Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia

Phase 3 Completed 561 enrolled KEMRI-Wellcome Trust Collaborative Research Program London School of Hygiene and Tropical Medicine · collab University of Nairobi · collab University of Oxford · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2011-09
Primary completion: 2013-09
Completion: 2013-09

Outcome

Met primary endpoint

paper CONCLUSIONS: Our findings confirm noninferiority of amoxicillin to benzyl penicillin PMID 25550349 ↗

paper Treatment failure was observed in 20 of 260 (7.7%) and 21 of 261 (8.0%) of patients in the amoxicillin and benzyl penicillin arms, respectively (risk difference, -0.3% [95% confidence interval, -5.0% to 4.3%]) PMID 25550349 ↗

Publications

Agweyu A, Gathara D, Oliwa J, Muinga N, Edwards T, Allen E, Maleche-Obimbo E, English M; Severe Pneumonia Study Group. Oral amoxicillin versus benzyl penicillin for severe pneumonia among kenyan children: a pragmatic randomized controlled noninferiority trial. Clin Infect Dis. 2015 Apr 15;60(8):1216-24. doi: 10.1093/cid/ciu1166. Epub 2014 Dec 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amoxicillin	Other / unclassified	45 mg/kg	Oral
Comparator	Benzylpenicillin	Unknown	50000 iu/kg	Intravenous