At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 561 enrolled
Drug / intervention
Amoxicillin +1 moredrug
Likely dose
Amoxicillin 45mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Amoxicillin Versus Benzyl Penicillin for Severe Childhood Pneumonia Amongst Inpatients: An Open Label Randomised Controlled Non-inferiority Trial
KEMRI-Wellcome Trust Collaborative Research Program·interventional·Posted Jul 22, 2011·Updated Feb 13, 2015
In Brief
A Phase 3 clinical trial evaluating Amoxicillin and Benzyl penicillin for Pneumonia. Completed, enrolled 561 participants across 6 sites.
Detailed Summary
This study seeks to determine whether clinical outcome following initial treatment of severe pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin. The study will also provide an estimate of the proportion of Kenyan children with severe pneumonia who fail treatment with a single antibiotic.
Study Details
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartSep 2011
Primary CompletionSep 2013
TodayJul 2026
First PostedJul 22, 2011
Enrollment StartSep 1, 2011
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.9 years ago
Interventions
Amoxicillindrug
Oral 45mg/kg 12 hourly
Benzyl penicillindrug
Intravenous 50,000IU/kg 6 hourly