drugset / Trial / NCT02372461
Randomized Trial of Amoxicillin Versus Placebo for (Fast Breathing) Pneumonia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The relative benefits and risks of antibiotic therapy in WHO defined fast breathing pneumonia in pre-school children in resource limited settings are controversial both at an individual and public health level. Most infections are viral or self-limiting and non-selective drug treatment has contributed to the global epidemic of antibiotic resistance. There is no high quality trial evidence in managing children with fast breathing in community settings and the WHO itself has called for evidence on which to update guidance. The investigators proposed non inferiority trial comparing standard antibiotic treatment with placebo in poor urban slum settings in South Asia to address this deficit.
Timeline
- Start
- 2014-11-09
- Primary completion
- 2017-11
- Completion
- 2017-11
Publications
- Jehan F, Nisar I, Kerai S, Balouch B, Brown N, Rahman N, Rizvi A, Shafiq Y, Zaidi AKM. Randomized Trial of Amoxicillin for Pneumonia in Pakistan. N Engl J Med. 2020 Jul 2;383(1):24-34. doi: 10.1056/NEJMoa1911998.
- Brown N, Rizvi A, Kerai S, Nisar MI, Rahman N, Baloch B, Jehan F. Recurrence of WHO-defined fast breathing pneumonia among infants, its occurrence and predictors in Pakistan: a nested case-control analysis. BMJ Open. 2020 Jan 7;10(1):e035277. doi: 10.1136/bmjopen-2019-035277.
- Jehan F, Nisar MI, Kerai S, Brown N, Balouch B, Hyder Z, Ambler G, Ginsburg AS, Zaidi AK. A double blind community-based randomized trial of amoxicillin versus placebo for fast breathing pneumonia in children aged 2-59 months in Karachi, Pakistan (RETAPP). BMC Infect Dis. 2016 Jan 13;16:13. doi: 10.1186/s12879-015-1334-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 500 mg | Oral |
| Comparator | Amoxicillin | Other / unclassified | 1000 mg | Oral |
| Comparator | Amoxicillin | Other / unclassified | 1500 mg | Oral |