This study compared the efficacy of amoxicillin, azithromycin, and gatifloxacin in treating acute rhinosinusitis. All three drugs significantly reduced symptoms and improved radiographic findings. Gatifloxacin was the most effective based on symptom and radiographic scoring, and had the fewest adverse effects. Azithromycin was also effective with fewer adverse effects than amoxicillin. The study concluded that gatifloxacin is the best treatment option for acute rhinosinusitis.

1. Vivek Sharma, R. K. Saxena, Geetanjali Sharma, K. C. Mishra, Shalini Sharma, D. C. Dhasmana
Association of Otolaryngologists of India 2011
Created By :
Nyoman Aditya Sindunata (FK UPH)
FitriaAyu Anggraini (FK UPN)
Pembimbing :
dr. Khairan, Sp.THT K-L

2. To compare the efficacy of gatifloxacin, azithromycin with
amoxicillin as positive control for the treatment ofAcute
rhinosinusitis (ARS).
To monitor adverse drug reaction profile of amoxicillin,
azithromycin and gatifloxacin in patient of ARS.
An open randomized trial of comparative efficacy and
safety of amoxicillin, azithromycin and gatifloxacin in
patients with ARS

3. Rhinosinusitis is a global problem
It is usually a disease of sino-nasal obstruction and bacterial
trapping. It is usually preceded by and occurs in tandom with
viral URTI.
Sinusitis is considered to be inherent part of the ‘‘common-cold
syndrome’’ and hence the term rhino-sinusitis defines this
disease more precisely.

4. When the sinus ostium is obstructed, the retained secretions may
become infected with a variety of pathogens, including viruses,
bacteria and fungi
There is always a preceding viral upper respiratory infection which
gets superimposed by bacterial infections.
for which antibiotics are commonly prescribed in 85–95% of
cases.
Inspite of disease being very common, there is likely possibility
of it being often mis-diagnosed. At the same time disease
warrants early diagnoses and timely antimicrobial treatment so
as to avoid complications.

5. The treatment of such a condition is still
emprical and quite controversial in terms of
anti-bacterial drug of choice, frequency, route
and duration of treatment and other adjuvant
drugs being used.
There is no general consensus among physicians world-wide
with regard to drug treatment of this disease. So the present
study was envisaged to compare different anti-microbial drugs
in treatment of ARS.

6. STUDY DESIGN
 An open randomized
trial of comparative
efficacy and safety of
amoxicillin,
azithromycin and
gatifloxacin in patients
with Acute
rhinosinusitis (ARS).
SUBJECTS
 Adults patients presenting in ENT OPD
at HIMS, JollyGrant, Dehradun during
the course of 1 year with a primary
diagnosis of clinically and radiologically
documented acute sinusitis of less then
or equal to 4 weeks duration were
enrolled with us.
 Eligible adults of either sex of at least 18
years of age were enrolled.
 Use of adjunctive treatment such as
antipyretic, phenylephrine nose drops or
xylometazoline spray were allowed.

7. With symptoms lasting for more than 1 week or
those with severe rhinosinusitis symptoms :
 Nasal discharge of any quality
 Facial pain unrelated to trauma
 Predominantly unilateral maxillary pain
 Maxillary toothache or pain when chewing
 Unilateral pain above and below eyes on bending
forward.
INCLUSION CRITERIA

8.  Patient with chronic symptoms ([1 month)
 Immuno compromised patient
 Patient with previous sinus surgery.
 Patient with antibiotic use with in past 1 week.
 Co-morbidity (diabetes, heart failure, immune deficiency).
 Pregnancy/breast-feeding.
 In take of antibiotics for less than 4 weeks.
 Other nasal disorders (nasal polyps).
 Concurrent bronchitis, current episodes of longer than 3 months.
 Know hypersensitivity to pencillins, macrolides, fluoro-qunolones.
 Hepatic, renal or immunological disorders.
 Coagulation disorders.
 Seizure disorder or any condition requiring therapy with major tranquilizers.
 Patients who required nasal or systemic steroids.
EXCLUSION CRITERIA

9.  Demographic characteristics
 Age, sex, occupation, socio-economic status
 Relevant medical history -> ENT examination

10. Diagnostic Criteria
at least 2 major / 1 major + 2 minor
Major Factors
• Facial pain / pressure
• Facial congestion / fullness
• Nasal obstruction
• Purulent rhinorrhoeae /
discoloured postnatal
discharge
• Hyposmia or anosmia
• Fever with preceding URTI
Minor Factors
• Headache
• Halitosis (foul breath)
• Fatigue
• Dental pain (maxillary
toothache)
• Cough

11.  After meeting criteria -> 3 groups @ 10 patients :
 Group 1: Patients on oral amoxicillin 500 mgTDS for
10 days.
 Group 2: Patients on oral azithromycin 500 mg OD for
5 days.
 Group 3: Patients on oral gatifloxacin 400 mg OD for
10 days.
 Evaluation of signs and symptoms :
 Day 1
 Primary end point : day 7 (group 2), day 12 (group 1, 3)
 Secondary end point : 28 days after post therapy

12.  Assessment of clinical signs and symptoms
 Overall clinical response rating and
radiographic findings
 Water’s view before and after drug treatment
(primary end point and secondary end point)

13. On admission and 2 days after the end of therapy
Assessment : resolved, improved, worsened, or unchanged

15.  Done simultaneously : monitoring adverse
drug reaction (each hospital visit)
 Grade :
 Mild : sign and symptoms, easily tolerated
 Moderate : discomfort -> affect daily activity
 Severe : inability to work / hospitalization /
permanent disability / life-threatening

16.  Done to test the efficacy
 Applying student’s t-test
 Results – reported according to an intent-to-
treat analysis

18.  Group I – amoxicillin (positive control)
 Highly significant fall of scoring : day 12 (P<0.001) and 40 (P<0.001)
 Group II – azithromycin
 Effective in significant reduction : day 7 (P<0.001) and 35 (P<0.01)
 Group III – gatifloxacin
 Effective in significant reduction : day 12 (P<0.001) and 40 (P<0.001)
*significant reduction in symptoms of acute sinusitis on visual analogue scale

19.  Effective : azithromycin = amoxicillin
 Reducing symptoms (VAS) on day 7 and 35 (P >
0.05)
 Most effective : gatifloxacin
 Reducing symptoms (VAS) on day 12 (P < 0.02)
and 35 (P < 0.05), compared to amoxicillin

20.  Group I – amoxicillin (positive control)
 Significant improvement : day 12 (P<0.05) and 40 (P<0.01)
 Group II – azithromycin
 Significant improvement : day 12 (P<0.05) and 40
(P<0.001)
 Group III – gatifloxacin
 Highly significant improvement : day 12 (P<0.001) and 40
(P<0.001)
*significant improvement in radiographic improvement

22.  Azithromycin : significant improvement
(radiographic) on day 7 (P < 0.01) and 35 (P <
0.01)
 Gatifloxacin :
 Very highly significant improvement
(radiographic) on day 40 (P < 0.001)
 Significant improvement on day 12 (P < 0.01),
compared to amoxicillin

25.  Primary goals of management of acute
sinusitis :
 Eradicate infection (systemic antimicrobial
treatment)
 Decrease the severity and duration of symptoms
 Prevent complications, i.e. micocoele, chronic
sinusitis
 Amoxicillin, azithromycin and gatifloxacin
 Effective : reducing symptoms onVAS scoring

27.  Amoxicillin, azithromycin, gatifloxacin
 Effective : reducing sign and symptoms –VAS
 Gatifloxacin
 Most effective drug : sign and symptoms –VAS and
radiographic scoring
 Least adverse events (mild), compared to other
 Azithromycin : 2nd safest drug (less adverse
effects)
 Conveniece of dosing -> patients compliance
 Conclusion : gatifloxacin – drug of choice
 Further study : prevalent nature of disease and
smaller sample size