Protocol%20for%20Thesis%20Faculty%20of%20Medical%20Sciences%20University%20of%20Delhi

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Protocol for Thesis Faculty of Medical
SciencesUniversity of Delhi

• Dr XYZ
• Postgraduate student
• Department of ABCD
• University College of Medical Sciences GTB
  Hospital

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Supervisor Dr. A Professor Dept. of
ABCD UCMS GTB Hospital Delhi Co-Supervisor
s Dr. B Professor Dept. of EFGH UCMS
GTB Hospital Delhi Dr. C Professor
Head Dept. of IJKL UCMS GTB
Hospital Delhi
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Title
Single Dose Azithromycin versus Ciprofloxacin
for Cholera in Children A Randomized Controlled
Trial
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Background

• Cholera significant health concern
• Ciprofloxacin effective
• Flouroquinolone resistance hence alternatives
  required
• Oral single-dose azithromycin good results in
  adults
• Children no similar studies

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Aim
Treatment efficacy of single dose Azithromycin
versus Ciprofloxacin in children with cholera
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Objectives

• To compare clinical success of single dose
  treatment with Azithromycin and with
  Ciprofloxacin in children with cholera
• To compare bacteriological success of single dose
  treatment with Azithromycin and with
  Ciprofloxacin in children with cholera

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• Setting Departments of ABCD and EFGH, University
  College of Medical Sciences and GTB Hospital,
  Delhi.
• Study Design Randomized, open labeled, clinical
  controlled trial.
• Study Period November 2017-March 2019
• Consent and Ethics Written informed consent and
  Institutional Ethical Clearance

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Participants

• Inclusion criteria
• Children (2-12 years) with (all three)
• Acute watery diarrhea (24 h)
• Severe dehydration,
• Positive for V. cholerae by HD examination or
  stool culture
• Exclusion criteria
• Severe under-nutrition
• Co-existing systemic illness
• Blood in stool
• Receiving antibiotic/antidiarrheal within
  preceding 24 h

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Sample size

• Equivalence study
• At least 87 patients (each group) to ensure
• difference in clinical success rate between
  groups should not exceed 10
• Power 80
• a error 5
• ß 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. 1996348(9023)296-300.

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Methods

• Randomization Simple
• Allocation 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 8 hourly (from drug delivery)
• Time of discharge 72 hours (day 3) or until
  resolution of watery diarrhea, whichever is
  later.
• Follow-up visit day 7

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Bacteriological procedures

• Stool collection Fresh stool / rectal swab
• Hanging drop examination
• Transport Alkaline peptone water/ Cary Blair
  media.
• Stool culture Bile salt agar, Mac Conkey agar
  and thiosulphate citrate bile sucrose agar.
• Incubation 37ºC for 24 hours
• Enrichment alkaline peptone water
• Serotyping Slide agglutination test
• Antimicrobial susceptibility testing Kirby-Bauer
  disc diffusion techinque

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Outcome measures
Primary
Secondary

• Clinical success (resolution of diarrhea within
  72 hrs )
• Bacteriological success (cessation of Vibrio
  cholerae excretion by day 3)

• Recovery Time total duration of diarrhea
• Total requirement of ORS/ intravenous therapy
• Proportion of children with clinical or
  bacteriological relapse

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Statistical analysis

• Chi-square/Fishers exact test to compare
  frequency of
• Clinical and Bacteriological success
• Clinical or bacteriological relapse
• Unpaired t-test to compare
• Duration of diarrhea excretion of Vibrio
• requirement of RL and ORS
• Significance _at_ Plt0.05
• Repeated measure ANOVA for variables like mean
  frequency of stool (Days 1, 2, 3 and 7) and
  vomiting _at_1 level of significance to allow
  multiple comparisons

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Thank you!