Injectable Amoxicillin Versus Injectable Ampicillin Plus Gentamicin in the Treatment of Severe Pneumonia in Children Aged 2 to 59 Months: Protocol for an Open-Label Randomized Controlled Trial

Background: Pneumonia causes about 0.9 million deaths worldwide each year. The World Health Organization (WHO) guidelines for the standard management of severe pneumonia requires parenteral ampicillin every 6 hours and once-daily parenteral gentamicin for 5 to 7 days. Although this treatment has con...

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Published in:JMIR research protocols 2020-11, Vol.9 (11), p.e17735-e17735
Main Authors: Shahrin, Lubaba, Chisti, Mohammod Jobayer, Shahid, Abu Sadat Mohammad Sayeem Bin, Rahman, Abu Sayem Mirza Mohammad Hasibur, Islam, Md. Zahidul, Afroze, Farzana, Huq, Sayeeda, Ahmed, Tahmeed
Format: Article
Language:English
Subjects:
Antibiotics
Case management
Clinical trials
Congenital diseases
Drug dosages
Enrollments
Guardians
Hospitalization
Hospitals
Informed consent
Laboratories
Mortality
Multimedia
Nosocomial infections
Patients
Penicillin
Pneumonia
Protocol
Sepsis
Signs
Streptococcus infections
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Summary:Background: Pneumonia causes about 0.9 million deaths worldwide each year. The World Health Organization (WHO) guidelines for the standard management of severe pneumonia requires parenteral ampicillin every 6 hours and once-daily parenteral gentamicin for 5 to 7 days. Although this treatment has contributed to the reduction of mortality, it requires nursing interventions every 6 hours for 7 days. Further intervention trials should be conducted to search for alternate antibiotics with better adherence, reduced cost, and reduced hospital stay. Parenteral amoxicillin is an effective alternative to ampicillin, as it has a longer half-life and broader coverage. Objective: The aim of this clinical trial is to compare the efficacy of a dose of injectable amoxicillin every 12 hours plus a once-daily dose of injectable gentamicin with a dose of injectable ampicillin every 6 hours plus a once-daily dose of injectable gentamicin in children hospitalized for severe pneumonia. Methods: This randomized, controlled, open-label, noninferiority trial is being conducted in Dhaka Hospital of the International Centre for Diarrheal Disease Research, Bangladesh. A sample size of 308 children with severe pneumonia will give adequate power to this study. Children aged 2 to 59 months are randomized to either intravenous ampicillin or intravenous amoxicillin, plus intravenous gentamicin in both study arms. The monitoring of the patients is carried out according to the WHO protocol for the treatment of severe pneumonia. The primary objective is the rate of treatment failure, defined by the persistence of danger signs of severe pneumonia beyond 48 hours or deterioration within 24 hours of initiation of the therapy. The secondary objectives are (1) improvement in or the resolution of danger signs since enrollment, (2) length of hospital stay, (3) death during hospitalization, and (4) rate of nosocomial infections. Results: Enrollment in the study started on January 1, 2018, and ended on October 31, 2019. Data entry and analysis are in progress. Findings from the study are expected to be disseminated in October 2020. Conclusions: Our study's findings will improve compliance with the use of antibiotics that require less frequent doses for the treatment of severe pneumonia. Trial Registration: ClinicalTrials.gov NCT03369093; https://clinicaltrials.gov/ct2/show/NCT03369093 International Registered Report Identifier (IRRID): DERR1-10.2196/17735
ISSN:1929-0748
1929-0748
DOI:10.2196/17735