ArticleJMIR research protocols2020
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.
Article in JMIR research protocols, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03369093 (Efficacy of Two Doses of Parenteral Amoxicillin Plus Single Dose Gentamicin Compared to Four Doses of Parenteral Ampicillin Plus Single Dose Gentamicin in Managing Children Hospitalized With WHO Classified Severe Pneumonia), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy of Two Doses of Parenteral Amoxicillin Plus Single Dose Gentamicin Compared to Four Doses of Parenteral Ampicillin Plus Single Dose Gentamicin in Managing Children Hospitalized With WHO Classified Severe Pneumonia: a RCT
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.
- Antibiotics for hospital-acquired pneumonia in neonates and children.The Cochrane database of systematic reviews · 2021Pooled it
- Derivation and validation of a clinical prediction model for risk-stratification of children hospitalized with severe pneumonia in Bangladesh.PLOS global public health · 2023Article
- Prevalence and predictors of magnesium imbalance among critically ill diarrheal children and their outcome in a developing country.PloS one · 2023Article
- Intravenous Amoxicillin Plus Intravenous Gentamicin for Children with Severe Pneumonia in Bangladesh: An Open-Label, Randomized, Non-Inferiority Controlled Trial.Life (Basel, Switzerland) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPneumonia 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.
objectiveThe 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.
methodsThis 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.
resultsEnrollment 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.
conclusionsOur study's findings will improve compliance with the use of antibiotics that require less frequent doses for the treatment of severe pneumonia.
trial registrationClinicalTrials.gov NCT03369093; https://clinicaltrials.gov/ct2/show/NCT03369093. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17735.
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