Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 9, 2020
Date Accepted: Aug 25, 2020
Methods for conducting an open labelled randomized controlled trial on Injectable Amoxicillin versus injectable Ampicillin plus Gentamicin in the treatment of severe pneumonia in children aged 2-59 months: a study protocol
ABSTRACT
Background:
Pneumonia is causing about 0.9 million deaths worldwide each year. World Health Organization (WHO) standard management of severe pneumonia requires six-hourly parenteral Ampicillin and once-daily parenteral Gentamicin for 5-7 days. Although this treatment has been contributed in reduction of mortality, it essentially requires 6 hourly nursing interventions for 7 days. Further intervention trials should be conducted for the search of alternate antibiotics with better adherence, cost and reduce hospital stay. Henceforth, parenteral Amoxicillin is an effective alternative to Ampicillin as it has a longer half-life and broader coverage.
Objective:
Aim of this clinical trial is to compare the efficacy of daily two doses of injectable Amoxicillin plus single-dose injectable Gentamicin with daily four doses of injectable Ampicillin plus single-dose injectable Gentamicin in children hospitalized for severe pneumonia.
Methods:
This randomized, controlled, open-label, non-inferiority trial is conducting in Dhaka hospital of International Centre for Diarrheal Disease Research Bangladesh (icddr,b). A sample size of 308 children with severe pneumonia will give adequate power to this study. Children between 2-59 months are randomized to either intravenous (IV) Ampicillin or IV Amoxicillin plus IV Gentamicin in both arm. Monitoring of the patients will be according to WHO treatment protocol of severe pneumonia. Rate of treatment failure compared by persistence of danger sign(s) of severe pneumonia beyond 48 hours, or deterioration within 24 hours of initiation of therapy. The secondary objectives are-length of hospital stay; death during hospitalization and rate of nosocomial infections.
Results:
Enrolment started from 1st January 2018 and continues till the end of August 2020.
Conclusions:
The findings of our study will improve the compliance of the use of antibiotics with lesser frequency in the treatment of severe pneumonia. Clinical Trial: Ethical approval (PR-17061, version 4.00) and Clinicaltrials.gov registration (NCT 03369093) obtained.
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