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The document discusses pneumonia treatment guidelines in Taiwan. It provides background on the etiology of community-acquired pneumonia (CAP) in Taiwan. It then summarizes the key changes between the 2018 and 2007 Taiwan pneumonia guidelines, including the use of a modified GRADE methodology, definitions of healthcare-associated pneumonia (HCAP) and pediatric pneumonia. The major sections of the 2018 guidelines covered CAP, hospital-acquired pneumonia (HAP), HCAP subdivided into nursing home-associated and hemodialysis-associated pneumonia, and pediatric pneumonia.

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周稚偵醫師 高雄榮民總醫院內科部感染科 下呼吸道感染 社區型肺炎
死亡率 2006 排名 2016 死亡率 495.4 惡性腫瘤 1 惡性腫瘤 439.4 139.3 腦血管疾病 2 心臟疾病 126.8 44.7 心臟性疾病 3 肺炎 50.3 43.8 糖尿病 4 腦血管疾病 26.9 34.9 事故傷害 5 糖尿病 28.6 31.9 肺炎 6 事故傷害 24.3 18.9 慢性肝病及肝硬化 7 慢性下呼吸道疾病 23.1 16.8 腎炎腎徵候群腎病變 8 高血壓性疾病 15.1 16.8 自殺 9 腎炎腎病症侯群腎病變 13.5 6.4 高血壓性疾病 10 慢性肝病及肝硬化 12.4 標準化死亡率(每10萬人口)
BSI RTI UTI SSI Others ID Hospitalized patients, Overall Patient# 128,868 343,023 323,079 73,953 314,609 1,987,429 % 6% 17% 16% 4% 16% 100%
Recommendations and Guidelines for the Treatment of Pneumonia in Taiwan • Epub: Dec 6, 2018 • Pub date: Feb 2019 2018 J Microbiol Immunol Infect 2019 Feb; 52(1):172-199.
台灣感染症醫學會 台灣胸腔暨重症加護醫學會 財團法人鄭德齡醫學發展基金會 台灣肺炎診治指引 2018年
https://pneumonia.idtaiwanguideline.org Web-book 網址: pneumonia.idtaiwanguideline.org
Why guidelines for pneumonia? • 按照指引治療可降低死亡率 − Dean NC. Decreased mortality after implementation of a treatment guideline for CAP. Am J Med 2001; 110: 451–57. − Martinez R. Impact of guidelines on outcome: the evidence. Semin Respir Crit Care Med 2009; 30: 172–78. • 減少住院日數 − McCabe C. Arch Intern Med. 2009;169(16):1525-1531 • 改善正確抗生素使用，減少抗生素使用日數 − Capelastegui A. Improvement of Process-of-Care and Outcomes after Implementing a Guideline for the Management of CAP: A Controlled Before- and-After Design Study. Clin Infect Dis 2004; 39:955–63
Reduced mortality in CAP & HAP patients with Guideline implementation Soo Hoo GW. Chest 2005;128(4):2778-87Dean NC. Am J Med 2001;110:451-7. CAP HAP 30% reduction in 30 day mortality Lower mortality at 14 days 14 day mortality: 8% vs 23%, (p=0.03)
台灣肺炎建議治療準則 1999 2007 2018 J Microbiol Immunol Infect 2019 Feb; 52(1):172-199.
Major Changes in Pneumonia Guidelines Taiwan 2018 vs 2007: What’s in it? Major changes • Use of modified GRADE methodology • Healthcare-associated pneumonia (HCAP) • Pediatric pneumonia What’s in it ? • CAP • HAP/VAP, pneumonia in RCW • HCAP: NHAP & HDAP • Pediatric pneumonia Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2018 Dec 6 Epub.
Major changes § Use of modified GRADE methodology § Healthcare-associated pneumonia (HCAP) § Pediatric pneumonia What’s in it ? § CAP § HAP/VAP, pneumonia in RCW § HCAP: NHAP & HDAP § Pediatric pneumonia Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2018 Dec 6 Epub. § CAP was defined as a pulmonary parenchymal acute infection in patients who acquire the condition in the community. § HAP was defined an infection of pulmonary parenchyma in patients who acquire the condition § at least 48 hours after admission to hospital, or § within 14 days after discharge from hospital. § VAP was defined as an infection of pulmonary parenchyma occurring at least 48 hours after endotracheal intubation. Recommendations and guidelines for treatment of pneumonia in Taiwan. J Microbiol Infect Immunol 2019 Feb; 52(1):172-199 於社區得到肺部間質急性感染 於醫療院所得到肺部間質急性感染 使用呼吸器 48 小時之後得到肺部間質急性感染 入院後 48 小時之後 前次出院後 14 天以內
§HCAP was defined as a pulmonary parenchymal infection in patients who was 1. Previously hospitalized in an acute care hospital for two or more days within 90 days prior to current infection; 2. resided in a nursing home or long term care facility; 3. received recent intravenous antibiotic therapy, chemotherapy, wound care or HD within 90 days prior to the current infection Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):172-199. 於以下情況得到肺部間質急性感染： 感染前 90 天內曾經住院超過兩天 居住於護理之家或安養院 感染前 90 天內曾經接受抗生素靜脈注射、化療、傷口照護或洗腎
HCAP: A distinct clinical entity in Taiwan • Unique medical care system in Taiwan − Numerous RCWs, caring for chronically ventilated patients, an − HD clinics, covered by the universal NHI − Recurrent hospitalization of patients in long term care facilities • A different epidemiology and antimicrobial resistance patterns in this patient population. • Stratified by risk of MDROs, subcategorized into two populations with special concern: 1. Hemodialysis-associated pneumonia (HDAP) 2. Nursing home-associated pneumonia (NHAP). Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):172-199.
社區性肺炎 CAP Management Guidelines
Yen MY. J Formos Med Assoc 2005 Oct;104(10):724-30. 26% 20% 13% 9% 5% 27% Etiology of Mild-to-Moderate CAP in Taiwan (N=100) S. pneumoniae Mycoplasma pneumoniae Chlaymydia pneumoniae Haemophilus influenzae Klebsiella pneumoniae Undetermined 72% had etiology Co-infection: 16 % Etiology of CAP in Taiwan (2002)
Etiology of Hospitalized CAP in Taiwan Pathogen Multicenter (2001-2002) N=168 Lauderdale TL Taipei (2001-2002) N=85 Ngeow YF Kaohsiung (2001-2002) N=100 Yen MY Taipei (2002-2004) N=65 Song JH S. pneumoniae 24% -- 26% 14% H. influenzae 5% -- 9% 2% S. aureus 2% -- 1% 1% K. pneumoniae 5% -- 5% 14% Other GNBs 2% -- 2% -- M. pneumoniae 14% 5% 20% -- C. pneumoniae 7% 6% 13% -- Legionella spp. 1% 4% 3% -- Viruses 10% -- 1% 2% M. tuberculosis 1% -- 2% -- Peto L. Trans R Soc Trop Med Hyg 2014; 108: 326–337
Etiology of CAP in Taiwan: Age matters Lauderdale TL. Respiratory Medicine (2005) 99, 1079–1086 Etiologic Agent 17-44 yrs N=59 45-59 yrs N=22 ≥ 60 yrs N=87 P-value Streptococcus pneumoniae 11 (17.2%) 4 (18.2%) 25 (28.7%) NS Klebsiella pneumoniae 1 (1.7%) 4 (18.2%) 3 (3.4%) < 0.01 Mycoplasma pneumoniae 12 (19.0%) 4 (18.2%) 8 (9.2%) NS Chlamydophila pneumoniae 3 (5.1%) 3 (13.6%) 6 (6.9%) NS Single infection 28 (47.5%) 16 (72.7%) 34 (39.1%) 0.02 Mixed infection (12.5%) 8 (13.6%) 2 (9.2%) 11 (12.6%) NS Etiology unidentified 23 (38.9%) 4 (18.2%) 42 (48.3) 0.03
Etiology of Severe CAP in Taiwan Northern Taiwan (2001) N=169 Taipei (2001-2003) N=62 Taichung (2002-2003) N=22 S. pneumoniae 2% 15% 14% H. influenzae 3% 3% 5% S. aureus 4% 10% 5% K. pneumoniae 11% 8% 9% Other GNBs 21% 16% 18% M. pneumoniae -- 2% 0 C. pneumoniae -- -- 5% Legionella spp. -- 2% 0 Viruses -- 2% -- M. tuberculosis -- -- -- Peto L. Trans R Soc Trop Med Hyg 2014; 108: 326–337 Severe CAP: ICU admission, ARDS, or ATS criteria for severe CAP
International CAP guidelines US & CANADA EUROPE ASIA OTHERS ATS/IDSA 2007 (2019) BTS 2009 NICE 2014 Taiwan 2018 South Africa 2017 CTS/CIDS 2000 ERS/ESCMID 2011 Japan 2006 Dutch SWAB 2012 Philippines 2016 Spanish SEPAR 2010 NEW!
CAP Guideline Logic Diagnosis Risk Stratification Additional Tests Site of Care Antibiotics Outpatient Inpatient ICU De-escalation Oral switch Tx Duration PSI: pneumonia severity index ICU: intensive care unit, Tx: treatment CAP: community acquired pneumonia Comorbidity Severity Score CURB-65, PSI Clinical + Radiologic Microbiological Biomarkers Empiric Target
CURB-65 Score for Mortality Risk Assessment NICE guidelines for pneumonia in adults 2014 Score Risk Mortality Site of Care 0-1 Low < 3 % Home 2 Intermediate 3-15 % Hospital 3-5 High > 15 % ICU Uremia (BUN > 19mg/dL) Respiratory Rate ≥ 30/min Blood Pressure drop (sBP < 90 or dBP < 60mmHg) Age ≥ 65 years Confusion (Abbreviated Mental Test score £ 8, or new disorientation in person, place or time)C U R B 65 Lim WS. Defining CAP severity on presentation to hospital: an international derivation and validation study. Thorax 2003;58;377-382.
Simplified CRB-65 Score Lim WS. Defining CAP severity on presentation to hospital: an international derivation and validation study. Thorax 2003;58;377-382. 1.2% 8.2% 31% Confusion Respiratory rate ≥ 30 Blood pressure drop (sBP < 90, dBP £ 60) ≥ 65 years Mortality 0 or 1 1 or 2 3 or 4
Pneumonia Severity Index (PSI) Fine MJ et. al N Engl J Med 1997; 336(4): 243-250 Risk Class Points Mortality (%) Recommended Site of Care I < 50 0.1 Outpatient II 51-70 0.6 Outpatient III 71-90 2.8 Outpatient or Brief Inpatient IV 91-130 8.2 Inpatient V > 130 29.2 Inpatient •Age (1 point per year) •Male: Yr •Female: Yr-10 •Nursing home residency +10 Demographics •Neoplasia +30 •Liver disease +20 •CHF +10 •Cerebrovascular disease +10 •Renal disease +10 Co-morbidities •Mental confusion +20 •RR ≥ 30/min, +20 •sBP < 90, +20 •Temp < 35 / ≥40 °C, +15 •HR ≥ 125/min, +15 Physical exam/ Vital signs •pH < 7.35, +30 •BUN ≥ 30, +20 •Na < 130 +20 •Glucose ≥ 250, +10 •Hct < 30%, +10 •Pleural effusion +10 •PaO2 < 60, +10 Laboratory / Imaging
IDSA Guidelines for CAP (2019) Severity Antibiotics Outpatients +comorbidity • Amoxicillin • Doxycycline • Macrolide • Dual therapy: amoxicillin/Augmentin, ceftriaxone/cefuroxime + macrolides/doxycycline, OR respiratory fluoroquinolone Inpatients • Levofloxacin, moxifloxacin or • Dual therapy: ampicillin/ceftriaxone/cefotaxime/ertapenem + macrolides (Fluroquinolones [FQ] if penicillin-allergic) ICU Ceftriaxone/cefotaxime/Unasyn + macrolides or FQ (FQ if penicillin allergic) P. aeruginosa Pip/tazo, cefepime, imipenem, meropenem + ciprofloxacin/levofloxacin or +/- aminoglycosides Or + azithromycin + aminoglycosides MRSA + vancomycin or linezolid
UK NICE Guidelines for CAP (2014) Severity Antibiotics Duration Low • Amoxicillin • Macrolide or tetracycline if allergic to penicillin 5 days (7 days)* Moderate • Dual therapy: Amoxicillin + macrolide 7-10 days (7 days)* High • Dual therapy: Amoxcillin-clavulanate + clarithromycin Penicillin + levofloxacin/ciprofloxacin Cefuroxime/ceftriaxone + clarithromycin Levofloxacin (Legionella) 7-10 days NICE guidelines for pneumonia in adults 2014 / BTS 2009* Lim WS, et al. Thorax 2015;0:1–3
ERS/ESCMID Guidelines for CAP (2011) Severity Antibiotics (in alphabetical order) Outpatients Moderate Aminopenicillin or +β-lactamase inhibitor ± macrolide Cefotaxime or ceftriaxone ± macrolide Levofloxacin /Moxifloxacin Penicillin G ± macrolide Severe Cefotaxime/ceftriaxone + macrolide moxifloxacin or levofloxacin ± cefotaxime/ceftriaxone Severe with Risk factors for P. aeruginosa Antipseudomonal cephalosporin or acylureidopenicillin/β-lactamase inhibitor or carbapenem (meropenem preferred, up to 6 g possible, 3 · 2 in 3-h infusion) PLUS ciprofloxacin / macrolide + aminoglycoside (gentamicin, tobramycin or amikacin) Woodhead M. Clin Microbiol Infect 2011; 17 (Suppl. 6): 1–24
Monotherapy or Combined Therapy for Empiric Treatment of Hospitalized CAP? • Cochrane Review 2012 • 28 trials, encompassing 5939 randomized patients. • Atypical antibiotic was monotherapy in all but 3 studies. • Only one study assessed a beta-lactam combined with a macrolide compared to the same beta-lactam. • No difference in mortality between the atypical arm and the non-atypical arm (RR 1.14; 95% CI 0.84 to 1.55), RR < 1 favors the atypical arm • No benefit of survival or clinical efficacy was shown with empirical atypical coverage in hospitalized patients with CAP (mostly FQ monotherapy vs b-lactams) Eliakim-Raz N. Cochrane Datab Syst Rev 2012;9. Art. No.: CD004418
CAP-START: b-lactam monotherapy noninferior to combined therapy in Hospitalized, non-ICU, CAP Strategy Results b-lactam b-lactam + Macrolide Fluoro- quinolone No of patients 656 739 888 Median age, yrs 70 (60-79) 70 (59-80) 71 (59-79) CURB-65 score (median) 1 (1-2) 1 (1-2) 1 (1-2) PSI score 84.6±29.0 84.8±27.8 85.4±28.5 90-day mortality 59 (9.0%) 82 (11.1%) 78 (8.8%) ITT: Risk of death + 1.9% (-0.6~4.4) - 0.6% (-2.8~1.9) Median LOS 6 days 6 days 6 days Median time to oral tx 4 (IQR 3-5) 4 (IQR 3-5) 3 (IQR 0-4) Postma DF. NEJM 2015 Apr;372:415-427. A cluster-randomized, crossover trial with strategies rotated in 4-month periods, non-ICU hospitalized CAP, in 7 hospitals in Netherlands (2011-2013).
Open-label, noninferior RCT: b-lactam Monotherapy vs Combination b-lactam + macrolide in moderate-severe CAP Switzerland (N=580) (2009-2013) • Primary Outcome: • Clinical Instability: % not reaching clinical stability at Day 7 Clinical stability defined as: • Heart rate < 100/min, • Systolic blood pressure > 90mmHg, • Temperature < 38.0°C, • Respiratory rate < 24/min • Oxygen saturation > 90% on room air Garin N. JAMA Intern Med. 2014;174(12):1894-1901
7.9% 3.1% 0% 2% 4% 6% 8% 10%Readmissions 30-day Monotherapy b-lactam Combination b-lactam + macrolide Combination b-lactam + macrolide Mortality, intensive care unit admission, complications, length of stay, and recurrence of pneumonia within 90 days did not differ between the 2 arms. Garin N. JAMA Intern Med. 2014;174(12):1894-1901 P=0.01 Difference = 7.6% P = 0.07 Atypical pathogens (HR 0.33) PSI category IV (HR 0.81) Monotherapy b-lactam 1-sided 90% CI: 13% d = 8%, NOT noninferior Difference = 7.6% (95% CI: -0.8 to 16%) P = 0.07 Open-label, noninferior RCT: b-lactam Monotherapy vs Combination b-lactam + macrolide in moderate-severe CAP Switzerland (N=580) (2009-2013)
CAP: 門診 - 低嚴重度 (sCRB-65: 0-1) Disease severity Disposition Preferred Alternative Duration Low severity CRB-65=0-1a No comorbidities, no history of antibiotic treatment in recent 3 months Outpatient Amoxicillin 500 mg-1g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb Presumed atypical pathogen Azithromycin 500 mg PO qd Clarithromycin 500 mg PO q12h Doxycycline 100 mg PO q12h Minocycline 100 mg PO q12h 5-7 dayse 3-5 dayse With comorbidities, or history of antibiotic treatment in recent 3 months Outpatient Amoxicillin 500 mg -1 g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb +/- Azithromycin 500 mg PO qd Clarithromycin 500 mg PO q12h Moxifloxacin 400 mg PO qdc Levofloxacin 500-750 mg PO qdc Gemifloxacin 320 mg PO qd Nemonoxacin 500 mg PO qdd 5-7 dayse 3-5 daysf Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):172-199.
CAP: 門診 - 低嚴重度 (sCRB-65: 0-1) Disease severity Disposition Preferred Alternative Duration Low severity CRB-65=0-1a No comorbidities, no history of antibiotic treatment in recent 3 months Outpatient Amoxicillin 500 mg-1g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb Presumed atypical pathogen Azithromycin 500 mg PO qd Clarithromycin 500 mg PO q12h Doxycycline 100 mg PO q12h Minocycline 100 mg PO q12h 5-7 dayse 3-5 dayse With comorbidities, or history of antibiotic treatment in recent 3 months Outpatient Amoxicillin 500 mg -1 g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb +/- Azithromycin 500 mg PO qd Clarithromycin 500 mg PO q12h Moxifloxacin 400 mg PO qdc Levofloxacin 500-750 mg PO qdc Gemifloxacin 320 mg PO qd Nemonoxacin 500 mg PO qdd 5-7 dayse 3-5 daysf 以目前台灣對肺炎鏈球 菌的流行病學研究， azithromycin對肺炎鏈 球菌的治療已不可信 Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):172-199.
CAP: 住院(非ICU) 低中度嚴重度 Disease severity Dispositi on Preferred Alternative Duration Low severity CURB-65 = 0-1a Hospitalized due to reasons other than disease severity (e.g. living alone, difficult to follow up, or accompanied with other clinical conditions requiring hospitalization.) Non-ICU Amoxicillin 500 mg-1 g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb Penicillin G 1-2 MU IV q6h-q4h Ampicillin 1-2 g IV q6h Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Cefuroxime 1.5 g IV q8hf +/- Azithromycin 500 mg PO QD Clarithromycin 500 mg PO q12h Moxifloxacin 400 mg PO/IV qdc Levofloxacin 500-750 mg PO/IV qdc Gemifloxacin 320 mg PO qd Nemonoxacin 500 mg PO qdd 5-7 dayse 3-5 daysf Moderate severity CURB-65 = 2-3a Non-ICU Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Cefuroxime 1.5 g IV q8hg Ceftriaxone 2 g IV qd Cefotaxime 1-2 g IV q8h Ertapenem 1 g IV qdh + Azithromycin 500 mg PO qd Clarithromycin 500 mg IV/PO q12h Moxifloxacin 400 mg IV qdc Levofloxacin 500-750 mg IV qdc Tigecyclinei 100 mg loading, then 50mg IV q12h Ceftaroline 500mg IV q12h 5-7 dayse 3-5 daysf Combination 優於monotherapy (1B)JMII 2019;52(1);171-199.
CAP: 住院(非ICU) 低中度嚴重度 Disease severity Dispositi on Preferred Alternative Duration Low severity CURB-65 = 0-1a Hospitalized due to reasons other than disease severity (e.g. living alone, difficult to follow up, or accompanied with other clinical conditions requiring hospitalization.) Non-ICU Amoxicillin 500 mg-1 g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb Penicillin G 1-2 MU IV q6h-q4h Ampicillin 1-2 g IV q6h Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Cefuroxime 1.5 g IV q8hf +/- Azithromycin 500 mg PO QD Clarithromycin 500 mg PO q12h Moxifloxacin 400 mg PO/IV qdc Levofloxacin 500-750 mg PO/IV qdc Gemifloxacin 320 mg PO qd Nemonoxacin 500 mg PO qdd 5-7 dayse 3-5 daysf Moderate severity CURB-65 = 2-3a Non-ICU Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Cefuroxime 1.5 g IV q8hg Ceftriaxone 2 g IV qd Cefotaxime 1-2 g IV q8h Ertapenem 1 g IV qdh + Azithromycin 500 mg PO qd Clarithromycin 500 mg IV/PO q12h Moxifloxacin 400 mg IV qdc Levofloxacin 500-750 mg IV qdc Tigecyclinei 100 mg loading, then 50mg IV q12h Ceftaroline 500mg IV q12h 5-7 dayse 3-5 daysf Combination 優於monotherapy (1B) 美國FDA曾對 tigecycline發出警訊，以靜脈途徑 用於FDA核准/ 非核准適應症時，死亡風險會提高， 因此建議在考慮選用 tigecycline時，照會感染症 專科醫師做評估。 JMII 2019;52(1);171-199.
FDA warning: Tigecycline increased all-cause mortality 2010/09 Pooled analysis of 13 Phase III & IV trials by FDA, showed higher risk of death, esp VAP, but nonsignificant. Adjusted risk difference 0.6% (95% CI: 0.1, 1.2) 2013/09 Higher risk of death for FDA approved indications: 2.5% (66/2640) vs. 1.8% (48/2628), adjusted RD 0.6% (95% CI 0.1,1.2) FDA new boxed warning in label Patients with Outcome of Death by Infection Type Mortality Rate Infection Type Tygacil Comparator drug Risk difference (95%CI) cSSSI 12/834 (1.4%) 6/813 (0.7%) 0.7 (-0.3, 1.7) cIAI 42/1382 (3.0%) 31/1393 (2.2%) 0.8 (-2.0, 2.4) CAP 12/424 (2.8%) 11/422 (2.6%) 0.2 (-2.0, 2.4) HAP 66/467 (14.1%) 57/467 (12.2%) 1.9 (-2.4, 6.3) Non-HAP 41/336 (12.2%) 42/345 (12.2%) 0.0 (-4.9, 4.9) VAP 25/131 (19.1%) 15/122 (12.3%) 6.8 (-2.1, 15.7) RP 11/128 (8.6%) 2/43 (4.7%) 3.9 (-4.0, 11.9) DFI 7/553 (1.3%) 3/508 (0.6%) 0.7 (-0.5, 1.8) Overall adjusted 150/3788 (4.0%) 110/3646 (3.0%) 0.6 (0.1, 1.2)
Severe CAP: Combination b-lactam + macrolide vs monotherapy Horita N et al. Respirology 2016; 21(7): 1193-200. Adding macrolide had a favorable effect on mortality only for severe CAP (observational studies) Meta-analysis 14 interventional studies (N= 1,011) 11 observational studies (N=33,332) Severity-based subgroup analysis and meta-regression
Meta-analysis: Severe CAP Combination b-lactam + FQ /Macrolide Vardakas KZ et al. Clin Microbiol Infect 2017; 23(4): 234-41. 17 studies, N=16,684, low quality evidence Mortality higher in b-lactam + FQ than +macrolide (RR 1.33), in American, not EU studies
Combination b-lactam + FQ /Macrolide Vardakas KZ et al. Clin Microbiol Infect 2017; 23(4): 234-41. In the meta-analysis of adjusted mortality data, a non- significant difference between b-lactam + FQ vs b-lactam + Macrolide (8 studies, adjusted RR=1.26)
CAP: 住院(ICU) 高度嚴重度 Disease severity Dispos ition Preferred Duration High severity CURB-65=3-5a ICU b-lactam based combination Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Cefuroxime 1.5g IV q8hg Ceftriaxone 2 g IV qd Cefotaxime 1-2 g IV q8h Ertapenem 1 g IV qdh One of the above b-lactam antibiotics plus one of the following macrolides: Clarithromycin 500 mg IV/PO q12h Azithromycin 500 mg PO qd or one of the following fluoroquinolones: Moxifloxacin 400 mg IV qdc Levofloxacin 500-750 mg IV qdc 7 dayse Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):171-199.
CAP: 治療療程 • 輕至中嚴重度肺炎: 如達到臨床穩定狀態，抗生 素療程 5-7 天為安全且有效1-3 (1B) • 高嚴重度肺炎: 如達到臨床穩定狀態，抗生素療 程 7 天為安全且有效4 (2C) • 輕至重度嚴重度肺炎: 如達到臨床穩定狀態，在 2-4天轉換針劑為口服抗生素為安全且有效（1B） 1. Li JZ, Winston LG. Efficacy of short-course antibiotic regimens for CAP: a meta-analysis. Am J Med 2007; 120(9): 783-90. 2. Dimopoulos G. Short- versus long-course antibacterial therapy for community-acquired pneumonia : a meta-analysis. Drugs 2008; 68(13): 1841-54. 3. Uranga A et al. Duration of Antibiotic Treatment in CAP: A Multicenter Randomized Clinical Trial. JAMA Intern Med 2016; 176(9): 1257-65. 4. Choudhury G. Seven-day antibiotic courses have similar efficacy to prolonged courses in severe CAP-a propensity-adjusted analysis. Clin Microbiol Infect 2011; 17(12): 1852-8. 資料來源: 台灣肺炎診治指引 2018年 臨床穩定狀態定義為: 體溫 ≤ 37.8 °C; ⼼跳 ≤ 100 下/每分鐘; 呼吸速率 ≤ 24 次/分鐘; 收縮壓 ≧ 90 mm Hg; 未使用氧氣時 的血氧濃度 ≧ 90% 或 pO2 ≧ 60 mm Hg; 能穩定地由口進食; 正常意識狀態（最後兩項為出院或改為口服抗生素需考慮之 條件；並非用來判斷感染治療無效之標準）
Early Switch to Oral Treatment for CAP Early oral switch vs IV groups Odds Ratio (95% CI) Treatment success • Intention-to-treat 0.76 (0.36〜1.59) • Per-protocol 0.92 (0.6〜1.39) Mortality 0.81 (0.49〜1.33) Recurrence of CAP 1.81 (0.70〜4.72) Drug-related adverse events 0.65 (0.48〜0.89)* Athanassa Z. Drugs 2008; 68 (17): 2469-2481 Mean difference Duration of hospitalization - 3.34 (-4.42〜 -2.25)*
7-day course in Severe CAP Propensity-adjusted analysis In the multivariable analysis, incorporating the propensity score as a covariate, 7-day antibiotic courses were not associated with: • 30-day mortality (adjusted OR (AOR) 0.67, 95% CI 0.21–2.16, p=0.5) • Mechanical ventilation and/or inotropic support (AOR 0.92, 95% CI 0.27– 3.16, p=0.9) • Complicated pneumonia (AOR 0.63, 95% CI 0.23–1.71, p=0.4). Therefore, none suggest a harmful effect of 7-day antibiotic course Choudhury G et al. Clin Microbiol Infect 2011; 17(12): 1852-8. Lee RWW et al. Respirology 2007; 12: 111-6 .20. Capelategui et al. CID 2004; 39: 995-63 Marrie TJ et al. JAMA 2000; 283: 749-55.
Special considerations in Empiric CAP treatment • Pseudomonas aeruginosa • MRSA • Aspiration • Tuberculosis
CAP: Pseudomonas aeruginosa Special condition Preferred Risk of Pseudomonas infection Piperacillin/tazobactam 4.5 g IV q8h-q6h Ticarcillin/clavulanate 3.1 g IV q6h Cefoperazone/sulbactam 4 g IV q12h Cefepime 2 g IV q8h Imipenem 500 mg IV q6h-1g IV q8h Meropenem 1 g IV q8h +/- * Ciprofloxacin 400 mg IV q8h-12h Levofloxacin 750 mg IV qd Risk factors for P. aeruginosa 1. Recent hospitalization 2. Frequent (> 4 events per year) or recent administration of antibiotics (last 3 months), 3. Severe chronic pulmonary disease (FEV1 < 30%) 4. Oral steroid use (>10 mg of prednisolone daily in the last 2 weeks) P. aeruginosa infection may be treated with two antipseudomonal drugs to reduce the chance of treatment failure. When the drug susceptibility test of the pathogen is available, antibiotics regimens should be deescalated to monotherapy. * 在治療有P. aeruginosa 感染風險的病患時，可考慮使用合併治療避免因抗 藥性造成治療失敗。但是⼀旦有確認的藥物敏感性試驗報告，就應該降階為 有效的單⼀療法。 Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):171-199.
CAP Special considerations: MRSA Special condition Preferred Risk of MRSA infection Vancomycin 15-20 mg/kg IV q8-12h Teicoplanin 6-12 mg/kg/dose IV q12h x 3-5 doses, then 6-12 mg/kg/dose qd Linezolid 600 mg PO/IV q12h Risk factors for Methicillin-resistant Staphylococcus aureus (MRSA) • History of MRSA acquisition • Admission to a unit where MRSA ≥ 20% of S .aureus isolates 1.由於 methicillin-resistant Staphylococcus aureus (MRSA)感染比例在台 灣並不算高，不建議例行性給予治療抗MRSA之抗生素。 2.但若是病人之前曾培養出MRSA，或是該醫療單位MRSA菌感染的風險較高 時 (≥ 20% of S. aureus isolates)，可考慮經驗性加上治療MRSA的藥物。 Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019 Feb;52(1):171-199.
CAP: Aspiration & anaerobic infection Special condition Preferred Risk of aspiration pneumonia and anaerobic infection Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Moxifloxacin 400 mg PO/IV qdc Ertapenem 1 g IV qd Or metronidazole 500 mg PO/IV q8h plus one of the following b-lactams: Cefaclor 500 mg PO q8hb Cefuroxime 1.5 g IV q8hg Risk factors for Aspiration pneumonia: Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019 Feb;52(1):171-199.
M.tuberculosis presenting as CAP Shen GH et al. Internat J Antimicrob Agents 2012;39:201– 205
Meta-analysis: Delayed treatment and resistance with FQ use Develop fluoroquinolone resistance: 2.7x Overall Delays: 19 days Chen TC e al . FQ are associated with delayed treatment and resistance in tuberculosis: a systematic review and meta-analysis. Int J Infect Dis 2011; 15(3): e211-6.
Meta-analysis: Delayed treatment and resistance with FQ use Develop fluoroquinolone resistance: 2.7x Overall Delays: 19 days Chen TC e al . FQ are associated with delayed treatment and resistance in tuberculosis: a systematic review and meta-analysis. Int J Infect Dis 2011; 15(3): e211-6. Fluoroquinolone經驗性療 法有延遲肺結核的診斷及增 加抗藥性的風險，在臨床已 懷疑結核感染的病人應審慎 評估後使用（2C）
CAP: Melioidosis g. 若是併有深部感染如中樞神經感染，建議加上TMP-SMX ⼀起使用 h. 若病患病況危急、有嚴重肺炎、深部感染、器官膿瘍、骨髓炎、感染性關節炎、中樞神經感染等情況，則 治療可延⻑⾄4 ⾄8 週或更久 i. 對sulphonamides 過敏者可使用amoxicillin/clavulanate j. 葉酸(Folic acid)可以減少或預防TMP-SMX 所造成之antifolate 的副作用但卻不影響TMP-SMX 的殺菌力 Pathogen Preferred Alternative Duration Burkholderia pseudomallei Intensive phasei,j Ceftazidime 50 mg/kg (up to 2g) IV q6h Meropenem 25 mg/kg (up to 1 g) IV q8h Imipenem 25 mg/kg (up to1gm) q8h Imipenem 25 mg/kg up to 1g IV q6h 14 daysk Eradication phase TMP/SMX PO < 40kg: 160/800 mg q12h; 40-60 kg: 240/1200 mg q12h; > 60 kg: 320/1600 mg q12h plus folic acidm 0.1 mg/kg up to 5 mg PO qd Amoxicillin/clavulanate 20/5 mg/kg PO q8h, up to maximum of 1500/375 mg PO q8h plus doxycycline 100 mg PO q12h ≥ 3 months Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019 Feb;52(1):171-199.
Thank You

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1091218-下呼吸道感染

  • 1.
  • 2.
    死亡率 2006 排名 2016死亡率 495.4 惡性腫瘤 1 惡性腫瘤 439.4 139.3 腦血管疾病 2 心臟疾病 126.8 44.7 心臟性疾病 3 肺炎 50.3 43.8 糖尿病 4 腦血管疾病 26.9 34.9 事故傷害 5 糖尿病 28.6 31.9 肺炎 6 事故傷害 24.3 18.9 慢性肝病及肝硬化 7 慢性下呼吸道疾病 23.1 16.8 腎炎腎徵候群腎病變 8 高血壓性疾病 15.1 16.8 自殺 9 腎炎腎病症侯群腎病變 13.5 6.4 高血壓性疾病 10 慢性肝病及肝硬化 12.4 標準化死亡率(每10萬人口)
  • 3.
    BSI RTI UTISSI Others ID Hospitalized patients, Overall Patient# 128,868 343,023 323,079 73,953 314,609 1,987,429 % 6% 17% 16% 4% 16% 100%
  • 4.
    Recommendations and Guidelinesfor the Treatment of Pneumonia in Taiwan • Epub: Dec 6, 2018 • Pub date: Feb 2019 2018 J Microbiol Immunol Infect 2019 Feb; 52(1):172-199.
  • 5.
  • 6.
  • 7.
    Why guidelines forpneumonia? • 按照指引治療可降低死亡率 − Dean NC. Decreased mortality after implementation of a treatment guideline for CAP. Am J Med 2001; 110: 451–57. − Martinez R. Impact of guidelines on outcome: the evidence. Semin Respir Crit Care Med 2009; 30: 172–78. • 減少住院日數 − McCabe C. Arch Intern Med. 2009;169(16):1525-1531 • 改善正確抗生素使用，減少抗生素使用日數 − Capelastegui A. Improvement of Process-of-Care and Outcomes after Implementing a Guideline for the Management of CAP: A Controlled Before- and-After Design Study. Clin Infect Dis 2004; 39:955–63
  • 8.
    Reduced mortality inCAP & HAP patients with Guideline implementation Soo Hoo GW. Chest 2005;128(4):2778-87Dean NC. Am J Med 2001;110:451-7. CAP HAP 30% reduction in 30 day mortality Lower mortality at 14 days 14 day mortality: 8% vs 23%, (p=0.03)
  • 9.
  • 10.
    Major Changes inPneumonia Guidelines Taiwan 2018 vs 2007: What’s in it? Major changes • Use of modified GRADE methodology • Healthcare-associated pneumonia (HCAP) • Pediatric pneumonia What’s in it ? • CAP • HAP/VAP, pneumonia in RCW • HCAP: NHAP & HDAP • Pediatric pneumonia Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2018 Dec 6 Epub.
  • 11.
    Major changes § Useof modified GRADE methodology § Healthcare-associated pneumonia (HCAP) § Pediatric pneumonia What’s in it ? § CAP § HAP/VAP, pneumonia in RCW § HCAP: NHAP & HDAP § Pediatric pneumonia Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2018 Dec 6 Epub. § CAP was defined as a pulmonary parenchymal acute infection in patients who acquire the condition in the community. § HAP was defined an infection of pulmonary parenchyma in patients who acquire the condition § at least 48 hours after admission to hospital, or § within 14 days after discharge from hospital. § VAP was defined as an infection of pulmonary parenchyma occurring at least 48 hours after endotracheal intubation. Recommendations and guidelines for treatment of pneumonia in Taiwan. J Microbiol Infect Immunol 2019 Feb; 52(1):172-199 於社區得到肺部間質急性感染 於醫療院所得到肺部間質急性感染 使用呼吸器 48 小時之後得到肺部間質急性感染 入院後 48 小時之後 前次出院後 14 天以內
  • 12.
    §HCAP was definedas a pulmonary parenchymal infection in patients who was 1. Previously hospitalized in an acute care hospital for two or more days within 90 days prior to current infection; 2. resided in a nursing home or long term care facility; 3. received recent intravenous antibiotic therapy, chemotherapy, wound care or HD within 90 days prior to the current infection Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):172-199. 於以下情況得到肺部間質急性感染： 感染前 90 天內曾經住院超過兩天 居住於護理之家或安養院 感染前 90 天內曾經接受抗生素靜脈注射、化療、傷口照護或洗腎
  • 13.
    HCAP: A distinctclinical entity in Taiwan • Unique medical care system in Taiwan − Numerous RCWs, caring for chronically ventilated patients, an − HD clinics, covered by the universal NHI − Recurrent hospitalization of patients in long term care facilities • A different epidemiology and antimicrobial resistance patterns in this patient population. • Stratified by risk of MDROs, subcategorized into two populations with special concern: 1. Hemodialysis-associated pneumonia (HDAP) 2. Nursing home-associated pneumonia (NHAP). Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):172-199.
  • 14.
  • 15.
    Yen MY. JFormos Med Assoc 2005 Oct;104(10):724-30. 26% 20% 13% 9% 5% 27% Etiology of Mild-to-Moderate CAP in Taiwan (N=100) S. pneumoniae Mycoplasma pneumoniae Chlaymydia pneumoniae Haemophilus influenzae Klebsiella pneumoniae Undetermined 72% had etiology Co-infection: 16 % Etiology of CAP in Taiwan (2002)
  • 16.
    Etiology of HospitalizedCAP in Taiwan Pathogen Multicenter (2001-2002) N=168 Lauderdale TL Taipei (2001-2002) N=85 Ngeow YF Kaohsiung (2001-2002) N=100 Yen MY Taipei (2002-2004) N=65 Song JH S. pneumoniae 24% -- 26% 14% H. influenzae 5% -- 9% 2% S. aureus 2% -- 1% 1% K. pneumoniae 5% -- 5% 14% Other GNBs 2% -- 2% -- M. pneumoniae 14% 5% 20% -- C. pneumoniae 7% 6% 13% -- Legionella spp. 1% 4% 3% -- Viruses 10% -- 1% 2% M. tuberculosis 1% -- 2% -- Peto L. Trans R Soc Trop Med Hyg 2014; 108: 326–337
  • 17.
    Etiology of CAPin Taiwan: Age matters Lauderdale TL. Respiratory Medicine (2005) 99, 1079–1086 Etiologic Agent 17-44 yrs N=59 45-59 yrs N=22 ≥ 60 yrs N=87 P-value Streptococcus pneumoniae 11 (17.2%) 4 (18.2%) 25 (28.7%) NS Klebsiella pneumoniae 1 (1.7%) 4 (18.2%) 3 (3.4%) < 0.01 Mycoplasma pneumoniae 12 (19.0%) 4 (18.2%) 8 (9.2%) NS Chlamydophila pneumoniae 3 (5.1%) 3 (13.6%) 6 (6.9%) NS Single infection 28 (47.5%) 16 (72.7%) 34 (39.1%) 0.02 Mixed infection (12.5%) 8 (13.6%) 2 (9.2%) 11 (12.6%) NS Etiology unidentified 23 (38.9%) 4 (18.2%) 42 (48.3) 0.03
  • 18.
    Etiology of SevereCAP in Taiwan Northern Taiwan (2001) N=169 Taipei (2001-2003) N=62 Taichung (2002-2003) N=22 S. pneumoniae 2% 15% 14% H. influenzae 3% 3% 5% S. aureus 4% 10% 5% K. pneumoniae 11% 8% 9% Other GNBs 21% 16% 18% M. pneumoniae -- 2% 0 C. pneumoniae -- -- 5% Legionella spp. -- 2% 0 Viruses -- 2% -- M. tuberculosis -- -- -- Peto L. Trans R Soc Trop Med Hyg 2014; 108: 326–337 Severe CAP: ICU admission, ARDS, or ATS criteria for severe CAP
  • 19.
    International CAP guidelines US& CANADA EUROPE ASIA OTHERS ATS/IDSA 2007 (2019) BTS 2009 NICE 2014 Taiwan 2018 South Africa 2017 CTS/CIDS 2000 ERS/ESCMID 2011 Japan 2006 Dutch SWAB 2012 Philippines 2016 Spanish SEPAR 2010 NEW!
  • 20.
    CAP Guideline Logic Diagnosis Risk Stratification AdditionalTests Site of Care Antibiotics Outpatient Inpatient ICU De-escalation Oral switch Tx Duration PSI: pneumonia severity index ICU: intensive care unit, Tx: treatment CAP: community acquired pneumonia Comorbidity Severity Score CURB-65, PSI Clinical + Radiologic Microbiological Biomarkers Empiric Target
  • 21.
    CURB-65 Score forMortality Risk Assessment NICE guidelines for pneumonia in adults 2014 Score Risk Mortality Site of Care 0-1 Low < 3 % Home 2 Intermediate 3-15 % Hospital 3-5 High > 15 % ICU Uremia (BUN > 19mg/dL) Respiratory Rate ≥ 30/min Blood Pressure drop (sBP < 90 or dBP < 60mmHg) Age ≥ 65 years Confusion (Abbreviated Mental Test score £ 8, or new disorientation in person, place or time)C U R B 65 Lim WS. Defining CAP severity on presentation to hospital: an international derivation and validation study. Thorax 2003;58;377-382.
  • 22.
    Simplified CRB-65 Score LimWS. Defining CAP severity on presentation to hospital: an international derivation and validation study. Thorax 2003;58;377-382. 1.2% 8.2% 31% Confusion Respiratory rate ≥ 30 Blood pressure drop (sBP < 90, dBP £ 60) ≥ 65 years Mortality 0 or 1 1 or 2 3 or 4
  • 23.
    Pneumonia Severity Index(PSI) Fine MJ et. al N Engl J Med 1997; 336(4): 243-250 Risk Class Points Mortality (%) Recommended Site of Care I < 50 0.1 Outpatient II 51-70 0.6 Outpatient III 71-90 2.8 Outpatient or Brief Inpatient IV 91-130 8.2 Inpatient V > 130 29.2 Inpatient •Age (1 point per year) •Male: Yr •Female: Yr-10 •Nursing home residency +10 Demographics •Neoplasia +30 •Liver disease +20 •CHF +10 •Cerebrovascular disease +10 •Renal disease +10 Co-morbidities •Mental confusion +20 •RR ≥ 30/min, +20 •sBP < 90, +20 •Temp < 35 / ≥40 °C, +15 •HR ≥ 125/min, +15 Physical exam/ Vital signs •pH < 7.35, +30 •BUN ≥ 30, +20 •Na < 130 +20 •Glucose ≥ 250, +10 •Hct < 30%, +10 •Pleural effusion +10 •PaO2 < 60, +10 Laboratory / Imaging
  • 25.
    IDSA Guidelines forCAP (2019) Severity Antibiotics Outpatients +comorbidity • Amoxicillin • Doxycycline • Macrolide • Dual therapy: amoxicillin/Augmentin, ceftriaxone/cefuroxime + macrolides/doxycycline, OR respiratory fluoroquinolone Inpatients • Levofloxacin, moxifloxacin or • Dual therapy: ampicillin/ceftriaxone/cefotaxime/ertapenem + macrolides (Fluroquinolones [FQ] if penicillin-allergic) ICU Ceftriaxone/cefotaxime/Unasyn + macrolides or FQ (FQ if penicillin allergic) P. aeruginosa Pip/tazo, cefepime, imipenem, meropenem + ciprofloxacin/levofloxacin or +/- aminoglycosides Or + azithromycin + aminoglycosides MRSA + vancomycin or linezolid
  • 26.
    UK NICE Guidelinesfor CAP (2014) Severity Antibiotics Duration Low • Amoxicillin • Macrolide or tetracycline if allergic to penicillin 5 days (7 days)* Moderate • Dual therapy: Amoxicillin + macrolide 7-10 days (7 days)* High • Dual therapy: Amoxcillin-clavulanate + clarithromycin Penicillin + levofloxacin/ciprofloxacin Cefuroxime/ceftriaxone + clarithromycin Levofloxacin (Legionella) 7-10 days NICE guidelines for pneumonia in adults 2014 / BTS 2009* Lim WS, et al. Thorax 2015;0:1–3
  • 27.
    ERS/ESCMID Guidelines forCAP (2011) Severity Antibiotics (in alphabetical order) Outpatients Moderate Aminopenicillin or +β-lactamase inhibitor ± macrolide Cefotaxime or ceftriaxone ± macrolide Levofloxacin /Moxifloxacin Penicillin G ± macrolide Severe Cefotaxime/ceftriaxone + macrolide moxifloxacin or levofloxacin ± cefotaxime/ceftriaxone Severe with Risk factors for P. aeruginosa Antipseudomonal cephalosporin or acylureidopenicillin/β-lactamase inhibitor or carbapenem (meropenem preferred, up to 6 g possible, 3 · 2 in 3-h infusion) PLUS ciprofloxacin / macrolide + aminoglycoside (gentamicin, tobramycin or amikacin) Woodhead M. Clin Microbiol Infect 2011; 17 (Suppl. 6): 1–24
  • 29.
    Monotherapy or CombinedTherapy for Empiric Treatment of Hospitalized CAP? • Cochrane Review 2012 • 28 trials, encompassing 5939 randomized patients. • Atypical antibiotic was monotherapy in all but 3 studies. • Only one study assessed a beta-lactam combined with a macrolide compared to the same beta-lactam. • No difference in mortality between the atypical arm and the non-atypical arm (RR 1.14; 95% CI 0.84 to 1.55), RR < 1 favors the atypical arm • No benefit of survival or clinical efficacy was shown with empirical atypical coverage in hospitalized patients with CAP (mostly FQ monotherapy vs b-lactams) Eliakim-Raz N. Cochrane Datab Syst Rev 2012;9. Art. No.: CD004418
  • 30.
    CAP-START: b-lactam monotherapynoninferior to combined therapy in Hospitalized, non-ICU, CAP Strategy Results b-lactam b-lactam + Macrolide Fluoro- quinolone No of patients 656 739 888 Median age, yrs 70 (60-79) 70 (59-80) 71 (59-79) CURB-65 score (median) 1 (1-2) 1 (1-2) 1 (1-2) PSI score 84.6±29.0 84.8±27.8 85.4±28.5 90-day mortality 59 (9.0%) 82 (11.1%) 78 (8.8%) ITT: Risk of death + 1.9% (-0.6~4.4) - 0.6% (-2.8~1.9) Median LOS 6 days 6 days 6 days Median time to oral tx 4 (IQR 3-5) 4 (IQR 3-5) 3 (IQR 0-4) Postma DF. NEJM 2015 Apr;372:415-427. A cluster-randomized, crossover trial with strategies rotated in 4-month periods, non-ICU hospitalized CAP, in 7 hospitals in Netherlands (2011-2013).
  • 31.
    Open-label, noninferior RCT:b-lactam Monotherapy vs Combination b-lactam + macrolide in moderate-severe CAP Switzerland (N=580) (2009-2013) • Primary Outcome: • Clinical Instability: % not reaching clinical stability at Day 7 Clinical stability defined as: • Heart rate < 100/min, • Systolic blood pressure > 90mmHg, • Temperature < 38.0°C, • Respiratory rate < 24/min • Oxygen saturation > 90% on room air Garin N. JAMA Intern Med. 2014;174(12):1894-1901
  • 32.
    7.9% 3.1% 0% 2% 4% 6% 8% 10%Readmissions 30-day Monotherapy b-lactam Combination b-lactam + macrolide Combination b-lactam+ macrolide Mortality, intensive care unit admission, complications, length of stay, and recurrence of pneumonia within 90 days did not differ between the 2 arms. Garin N. JAMA Intern Med. 2014;174(12):1894-1901 P=0.01 Difference = 7.6% P = 0.07 Atypical pathogens (HR 0.33) PSI category IV (HR 0.81) Monotherapy b-lactam 1-sided 90% CI: 13% d = 8%, NOT noninferior Difference = 7.6% (95% CI: -0.8 to 16%) P = 0.07 Open-label, noninferior RCT: b-lactam Monotherapy vs Combination b-lactam + macrolide in moderate-severe CAP Switzerland (N=580) (2009-2013)
  • 33.
    CAP: 門診 -低嚴重度 (sCRB-65: 0-1) Disease severity Disposition Preferred Alternative Duration Low severity CRB-65=0-1a No comorbidities, no history of antibiotic treatment in recent 3 months Outpatient Amoxicillin 500 mg-1g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb Presumed atypical pathogen Azithromycin 500 mg PO qd Clarithromycin 500 mg PO q12h Doxycycline 100 mg PO q12h Minocycline 100 mg PO q12h 5-7 dayse 3-5 dayse With comorbidities, or history of antibiotic treatment in recent 3 months Outpatient Amoxicillin 500 mg -1 g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb +/- Azithromycin 500 mg PO qd Clarithromycin 500 mg PO q12h Moxifloxacin 400 mg PO qdc Levofloxacin 500-750 mg PO qdc Gemifloxacin 320 mg PO qd Nemonoxacin 500 mg PO qdd 5-7 dayse 3-5 daysf Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):172-199.
  • 34.
    CAP: 門診 -低嚴重度 (sCRB-65: 0-1) Disease severity Disposition Preferred Alternative Duration Low severity CRB-65=0-1a No comorbidities, no history of antibiotic treatment in recent 3 months Outpatient Amoxicillin 500 mg-1g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb Presumed atypical pathogen Azithromycin 500 mg PO qd Clarithromycin 500 mg PO q12h Doxycycline 100 mg PO q12h Minocycline 100 mg PO q12h 5-7 dayse 3-5 dayse With comorbidities, or history of antibiotic treatment in recent 3 months Outpatient Amoxicillin 500 mg -1 g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb +/- Azithromycin 500 mg PO qd Clarithromycin 500 mg PO q12h Moxifloxacin 400 mg PO qdc Levofloxacin 500-750 mg PO qdc Gemifloxacin 320 mg PO qd Nemonoxacin 500 mg PO qdd 5-7 dayse 3-5 daysf 以目前台灣對肺炎鏈球 菌的流行病學研究， azithromycin對肺炎鏈 球菌的治療已不可信 Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):172-199.
  • 35.
    CAP: 住院(非ICU) 低中度嚴重度 Diseaseseverity Dispositi on Preferred Alternative Duration Low severity CURB-65 = 0-1a Hospitalized due to reasons other than disease severity (e.g. living alone, difficult to follow up, or accompanied with other clinical conditions requiring hospitalization.) Non-ICU Amoxicillin 500 mg-1 g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb Penicillin G 1-2 MU IV q6h-q4h Ampicillin 1-2 g IV q6h Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Cefuroxime 1.5 g IV q8hf +/- Azithromycin 500 mg PO QD Clarithromycin 500 mg PO q12h Moxifloxacin 400 mg PO/IV qdc Levofloxacin 500-750 mg PO/IV qdc Gemifloxacin 320 mg PO qd Nemonoxacin 500 mg PO qdd 5-7 dayse 3-5 daysf Moderate severity CURB-65 = 2-3a Non-ICU Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Cefuroxime 1.5 g IV q8hg Ceftriaxone 2 g IV qd Cefotaxime 1-2 g IV q8h Ertapenem 1 g IV qdh + Azithromycin 500 mg PO qd Clarithromycin 500 mg IV/PO q12h Moxifloxacin 400 mg IV qdc Levofloxacin 500-750 mg IV qdc Tigecyclinei 100 mg loading, then 50mg IV q12h Ceftaroline 500mg IV q12h 5-7 dayse 3-5 daysf Combination 優於monotherapy (1B)JMII 2019;52(1);171-199.
  • 36.
    CAP: 住院(非ICU) 低中度嚴重度 Diseaseseverity Dispositi on Preferred Alternative Duration Low severity CURB-65 = 0-1a Hospitalized due to reasons other than disease severity (e.g. living alone, difficult to follow up, or accompanied with other clinical conditions requiring hospitalization.) Non-ICU Amoxicillin 500 mg-1 g PO q8h Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Cefaclor 500 mg PO q8hb Penicillin G 1-2 MU IV q6h-q4h Ampicillin 1-2 g IV q6h Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Cefuroxime 1.5 g IV q8hf +/- Azithromycin 500 mg PO QD Clarithromycin 500 mg PO q12h Moxifloxacin 400 mg PO/IV qdc Levofloxacin 500-750 mg PO/IV qdc Gemifloxacin 320 mg PO qd Nemonoxacin 500 mg PO qdd 5-7 dayse 3-5 daysf Moderate severity CURB-65 = 2-3a Non-ICU Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Cefuroxime 1.5 g IV q8hg Ceftriaxone 2 g IV qd Cefotaxime 1-2 g IV q8h Ertapenem 1 g IV qdh + Azithromycin 500 mg PO qd Clarithromycin 500 mg IV/PO q12h Moxifloxacin 400 mg IV qdc Levofloxacin 500-750 mg IV qdc Tigecyclinei 100 mg loading, then 50mg IV q12h Ceftaroline 500mg IV q12h 5-7 dayse 3-5 daysf Combination 優於monotherapy (1B) 美國FDA曾對 tigecycline發出警訊，以靜脈途徑 用於FDA核准/ 非核准適應症時，死亡風險會提高， 因此建議在考慮選用 tigecycline時，照會感染症 專科醫師做評估。 JMII 2019;52(1);171-199.
  • 37.
    FDA warning: Tigecyclineincreased all-cause mortality 2010/09 Pooled analysis of 13 Phase III & IV trials by FDA, showed higher risk of death, esp VAP, but nonsignificant. Adjusted risk difference 0.6% (95% CI: 0.1, 1.2) 2013/09 Higher risk of death for FDA approved indications: 2.5% (66/2640) vs. 1.8% (48/2628), adjusted RD 0.6% (95% CI 0.1,1.2) FDA new boxed warning in label Patients with Outcome of Death by Infection Type Mortality Rate Infection Type Tygacil Comparator drug Risk difference (95%CI) cSSSI 12/834 (1.4%) 6/813 (0.7%) 0.7 (-0.3, 1.7) cIAI 42/1382 (3.0%) 31/1393 (2.2%) 0.8 (-2.0, 2.4) CAP 12/424 (2.8%) 11/422 (2.6%) 0.2 (-2.0, 2.4) HAP 66/467 (14.1%) 57/467 (12.2%) 1.9 (-2.4, 6.3) Non-HAP 41/336 (12.2%) 42/345 (12.2%) 0.0 (-4.9, 4.9) VAP 25/131 (19.1%) 15/122 (12.3%) 6.8 (-2.1, 15.7) RP 11/128 (8.6%) 2/43 (4.7%) 3.9 (-4.0, 11.9) DFI 7/553 (1.3%) 3/508 (0.6%) 0.7 (-0.5, 1.8) Overall adjusted 150/3788 (4.0%) 110/3646 (3.0%) 0.6 (0.1, 1.2)
  • 38.
    Severe CAP: Combinationb-lactam + macrolide vs monotherapy Horita N et al. Respirology 2016; 21(7): 1193-200. Adding macrolide had a favorable effect on mortality only for severe CAP (observational studies) Meta-analysis 14 interventional studies (N= 1,011) 11 observational studies (N=33,332) Severity-based subgroup analysis and meta-regression
  • 39.
    Meta-analysis: Severe CAP Combinationb-lactam + FQ /Macrolide Vardakas KZ et al. Clin Microbiol Infect 2017; 23(4): 234-41. 17 studies, N=16,684, low quality evidence Mortality higher in b-lactam + FQ than +macrolide (RR 1.33), in American, not EU studies
  • 40.
    Combination b-lactam +FQ /Macrolide Vardakas KZ et al. Clin Microbiol Infect 2017; 23(4): 234-41. In the meta-analysis of adjusted mortality data, a non- significant difference between b-lactam + FQ vs b-lactam + Macrolide (8 studies, adjusted RR=1.26)
  • 41.
    CAP: 住院(ICU) 高度嚴重度 Diseaseseverity Dispos ition Preferred Duration High severity CURB-65=3-5a ICU b-lactam based combination Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Cefuroxime 1.5g IV q8hg Ceftriaxone 2 g IV qd Cefotaxime 1-2 g IV q8h Ertapenem 1 g IV qdh One of the above b-lactam antibiotics plus one of the following macrolides: Clarithromycin 500 mg IV/PO q12h Azithromycin 500 mg PO qd or one of the following fluoroquinolones: Moxifloxacin 400 mg IV qdc Levofloxacin 500-750 mg IV qdc 7 dayse Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):171-199.
  • 42.
    CAP: 治療療程 • 輕至中嚴重度肺炎:如達到臨床穩定狀態，抗生 素療程 5-7 天為安全且有效1-3 (1B) • 高嚴重度肺炎: 如達到臨床穩定狀態，抗生素療 程 7 天為安全且有效4 (2C) • 輕至重度嚴重度肺炎: 如達到臨床穩定狀態，在 2-4天轉換針劑為口服抗生素為安全且有效（1B） 1. Li JZ, Winston LG. Efficacy of short-course antibiotic regimens for CAP: a meta-analysis. Am J Med 2007; 120(9): 783-90. 2. Dimopoulos G. Short- versus long-course antibacterial therapy for community-acquired pneumonia : a meta-analysis. Drugs 2008; 68(13): 1841-54. 3. Uranga A et al. Duration of Antibiotic Treatment in CAP: A Multicenter Randomized Clinical Trial. JAMA Intern Med 2016; 176(9): 1257-65. 4. Choudhury G. Seven-day antibiotic courses have similar efficacy to prolonged courses in severe CAP-a propensity-adjusted analysis. Clin Microbiol Infect 2011; 17(12): 1852-8. 資料來源: 台灣肺炎診治指引 2018年 臨床穩定狀態定義為: 體溫 ≤ 37.8 °C; ⼼跳 ≤ 100 下/每分鐘; 呼吸速率 ≤ 24 次/分鐘; 收縮壓 ≧ 90 mm Hg; 未使用氧氣時 的血氧濃度 ≧ 90% 或 pO2 ≧ 60 mm Hg; 能穩定地由口進食; 正常意識狀態（最後兩項為出院或改為口服抗生素需考慮之 條件；並非用來判斷感染治療無效之標準）
  • 43.
    Early Switch toOral Treatment for CAP Early oral switch vs IV groups Odds Ratio (95% CI) Treatment success • Intention-to-treat 0.76 (0.36〜1.59) • Per-protocol 0.92 (0.6〜1.39) Mortality 0.81 (0.49〜1.33) Recurrence of CAP 1.81 (0.70〜4.72) Drug-related adverse events 0.65 (0.48〜0.89)* Athanassa Z. Drugs 2008; 68 (17): 2469-2481 Mean difference Duration of hospitalization - 3.34 (-4.42〜 -2.25)*
  • 44.
    7-day course inSevere CAP Propensity-adjusted analysis In the multivariable analysis, incorporating the propensity score as a covariate, 7-day antibiotic courses were not associated with: • 30-day mortality (adjusted OR (AOR) 0.67, 95% CI 0.21–2.16, p=0.5) • Mechanical ventilation and/or inotropic support (AOR 0.92, 95% CI 0.27– 3.16, p=0.9) • Complicated pneumonia (AOR 0.63, 95% CI 0.23–1.71, p=0.4). Therefore, none suggest a harmful effect of 7-day antibiotic course Choudhury G et al. Clin Microbiol Infect 2011; 17(12): 1852-8. Lee RWW et al. Respirology 2007; 12: 111-6 .20. Capelategui et al. CID 2004; 39: 995-63 Marrie TJ et al. JAMA 2000; 283: 749-55.
  • 45.
    Special considerations in EmpiricCAP treatment • Pseudomonas aeruginosa • MRSA • Aspiration • Tuberculosis
  • 46.
    CAP: Pseudomonas aeruginosa Specialcondition Preferred Risk of Pseudomonas infection Piperacillin/tazobactam 4.5 g IV q8h-q6h Ticarcillin/clavulanate 3.1 g IV q6h Cefoperazone/sulbactam 4 g IV q12h Cefepime 2 g IV q8h Imipenem 500 mg IV q6h-1g IV q8h Meropenem 1 g IV q8h +/- * Ciprofloxacin 400 mg IV q8h-12h Levofloxacin 750 mg IV qd Risk factors for P. aeruginosa 1. Recent hospitalization 2. Frequent (> 4 events per year) or recent administration of antibiotics (last 3 months), 3. Severe chronic pulmonary disease (FEV1 < 30%) 4. Oral steroid use (>10 mg of prednisolone daily in the last 2 weeks) P. aeruginosa infection may be treated with two antipseudomonal drugs to reduce the chance of treatment failure. When the drug susceptibility test of the pathogen is available, antibiotics regimens should be deescalated to monotherapy. * 在治療有P. aeruginosa 感染風險的病患時，可考慮使用合併治療避免因抗 藥性造成治療失敗。但是⼀旦有確認的藥物敏感性試驗報告，就應該降階為 有效的單⼀療法。 Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019;52(1):171-199.
  • 47.
    CAP Special considerations:MRSA Special condition Preferred Risk of MRSA infection Vancomycin 15-20 mg/kg IV q8-12h Teicoplanin 6-12 mg/kg/dose IV q12h x 3-5 doses, then 6-12 mg/kg/dose qd Linezolid 600 mg PO/IV q12h Risk factors for Methicillin-resistant Staphylococcus aureus (MRSA) • History of MRSA acquisition • Admission to a unit where MRSA ≥ 20% of S .aureus isolates 1.由於 methicillin-resistant Staphylococcus aureus (MRSA)感染比例在台 灣並不算高，不建議例行性給予治療抗MRSA之抗生素。 2.但若是病人之前曾培養出MRSA，或是該醫療單位MRSA菌感染的風險較高 時 (≥ 20% of S. aureus isolates)，可考慮經驗性加上治療MRSA的藥物。 Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019 Feb;52(1):171-199.
  • 48.
    CAP: Aspiration &anaerobic infection Special condition Preferred Risk of aspiration pneumonia and anaerobic infection Amoxicillin/clavulanate 1-2 g PO q12h Ampicillin/sulbactam 375-750 mg PO q12h Amoxicillin/clavulanate 1.2 g IV q8h Ampicillin/sulbactam 1.5-3 g IV q6h Moxifloxacin 400 mg PO/IV qdc Ertapenem 1 g IV qd Or metronidazole 500 mg PO/IV q8h plus one of the following b-lactams: Cefaclor 500 mg PO q8hb Cefuroxime 1.5 g IV q8hg Risk factors for Aspiration pneumonia: Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019 Feb;52(1):171-199.
  • 49.
    M.tuberculosis presenting asCAP Shen GH et al. Internat J Antimicrob Agents 2012;39:201– 205
  • 50.
    Meta-analysis: Delayed treatmentand resistance with FQ use Develop fluoroquinolone resistance: 2.7x Overall Delays: 19 days Chen TC e al . FQ are associated with delayed treatment and resistance in tuberculosis: a systematic review and meta-analysis. Int J Infect Dis 2011; 15(3): e211-6.
  • 51.
    Meta-analysis: Delayed treatmentand resistance with FQ use Develop fluoroquinolone resistance: 2.7x Overall Delays: 19 days Chen TC e al . FQ are associated with delayed treatment and resistance in tuberculosis: a systematic review and meta-analysis. Int J Infect Dis 2011; 15(3): e211-6. Fluoroquinolone經驗性療 法有延遲肺結核的診斷及增 加抗藥性的風險，在臨床已 懷疑結核感染的病人應審慎 評估後使用（2C）
  • 52.
    CAP: Melioidosis g. 若是併有深部感染如中樞神經感染，建議加上TMP-SMX⼀起使用 h. 若病患病況危急、有嚴重肺炎、深部感染、器官膿瘍、骨髓炎、感染性關節炎、中樞神經感染等情況，則 治療可延⻑⾄4 ⾄8 週或更久 i. 對sulphonamides 過敏者可使用amoxicillin/clavulanate j. 葉酸(Folic acid)可以減少或預防TMP-SMX 所造成之antifolate 的副作用但卻不影響TMP-SMX 的殺菌力 Pathogen Preferred Alternative Duration Burkholderia pseudomallei Intensive phasei,j Ceftazidime 50 mg/kg (up to 2g) IV q6h Meropenem 25 mg/kg (up to 1 g) IV q8h Imipenem 25 mg/kg (up to1gm) q8h Imipenem 25 mg/kg up to 1g IV q6h 14 daysk Eradication phase TMP/SMX PO < 40kg: 160/800 mg q12h; 40-60 kg: 240/1200 mg q12h; > 60 kg: 320/1600 mg q12h plus folic acidm 0.1 mg/kg up to 5 mg PO qd Amoxicillin/clavulanate 20/5 mg/kg PO q8h, up to maximum of 1500/375 mg PO q8h plus doxycycline 100 mg PO q12h ≥ 3 months Recommendations and guidelines for treatment of pneumonia in Taiwan. JMII 2019 Feb;52(1):171-199.
  • 53.