Sample protocol presentation 2013


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Prototype Protocol for presentation before the PG committee, UCMS, University of Delhi

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  • Severe under-nutrition (weight for age less than 60% of 50th percentile of CDC 2000 standards).
  • (30 mL/kg in first ½ hour; by 70 mL/kg over next 2½ hours)
  • Sample protocol presentation 2013

    1. 1. Single Dose Azithromycin versus Ciprofloxacin for Cholera in Children: A Randomized Controlled Trial Dr Pooja Dewan Postgraduate student Department of Pediatrics University College of Medical Sciences & GTB Hospital
    2. 2. Supervisor : Dr. Piyush Gupta Professor Dept. of Pediatrics UCMS & GTB Hospital Delhi Co-Supervisors : Dr. Shukla Das Professor Dept. of Microbiology UCMS & GTB Hospital Delhi Dr MMA Faridi Professor & Head Dept. of Pediatrics UCMS & GTB Hospital Delhi
    3. 3. Background • Cholera is a significant health problem in children • Ciprofloxacin proven an effective drug • Emergence of flouroquinolone resistance in Vibrio cholerae • Alternate drug required • Single-dose oral azithromycin shown good results for cholera in adults • No similar studies in Children
    4. 4. Aim: to evaluate the role of Azithromycin in children with cholera Primary Objective: To compare Azithromycin with Ciprofloxacin, both as single dose treatment, in children with cholera, in terms of clinical success (resolution of diarrhea) and bacteriological success (cessation of excretion of Vibrio cholerae) Secondary Objectives: To compare recovery time, requirement of ORS or IV fluids, and relapse rate
    5. 5. • Setting: Departments of Pediatrics and Microbiology, University College of Medical Sciences and GTB Hospital, Delhi. • Study Design: Randomized, open labeled, clinical controlled trial. • Study Period: April 1, 2011-March 31, 2012 • Consent and Ethics: Written informed consent and Institutional Ethical Clearance
    6. 6. Participants Inclusion criteria Children between 2-12 years with •Acute watery diarrhea for ≤24 h •Severe dehydration, and •Positive for V. cholerae by HD examination or stool culture Exclusion criteria •Severe undernutrition •Co-existing systemic illness •Blood in stool •Receiving an antibiotic/antidiarrheal within preceding 24 h
    7. 7. Sample size • Equivalence study • At least 87 patients in each treatment group to show that the difference in rates of clinical success between the two groups does not exceed 10%; Power= 80%, α error= 5%, β error= 20% Khan WA, et al. Randomised controlled comparison of single- dose ciprofloxacin and doxycycline for cholera caused by Vibrio cholerae 01 or 0139. Lancet. 1996;348(9023):296-300.
    8. 8. Methods • Randomization: Simple randomization • Allocation by sealed envelope technique • Intervention: Immediate rehydration (WHO Guidelines) followed by Oral azithromycin {20 mg/kg, dispersible tab} single dose Oral ciprofloxacin {20mg/kg dispersible tab} single dose • Monitoring: Every 8 hourly from time of drug delivery • Time of discharge: 72 hours (day 3) or until resolution of watery diarrhea, whichever is later. • Follow-up visit on day 7
    9. 9. Bacteriological procedures • Stool collection: Fresh stool sample/ rectal swab • Hanging drop examination • Transport : Alkaline peptone water or Cary Blair media. • Stool culture: Bile salt agar, Mac Conkey agar and thiosulphate citrate bile sucrose agar. Incubation at 37ºC for 24 hours, followed by enrichment (alkaline peptone water) Serotyping: Slide agglutination test Antimicrobial susceptibility testing: Kirby-Bauer disc diffusion techinque
    10. 10. Outcome measures Primary • Clinical success (resolution of diarrhea within 72 hrs after the start of therapy ) • Bacteriological success (cessation of excretion of Vibrio cholerae by day 3) Secondary • Total duration of diarrhea (recovery Time) • Total requirement of ORS or intravenous therapy • Proportion of children with clinical or bacteriological relapse
    11. 11. Statistical analysis • Frequency of Clinical and Bacteriological success, and clinical or bacteriological relapse will be compared by Chi-square or Fisher’s exact test. • Duration of diarrhea and excretion of Vibrio and requirement of RL and ORS will be compared by unpaired t-test. • Significant @ P<0.05 • Variables measured repeatedly like mean frequency of stool (Days 1, 2, 3 and 7) and vomiting, will be analyzed with repeated measure ANOVA at 1% level of significance to allow for multiple comparisons.