3 Days Amoxicillin Versus Placebo for Fast Breathing Childhood Pneumonia in Malawi

Summary

The purpose of this study to assess the effectiveness of no antibiotic treatment for fast breathing, community-acquired childhood pneumonia in a malaria-endemic region of Malawi.

Timeline

Start

2016-06

Primary completion

2019-03

Completion

2019-06

Publications

• Mvalo T, McCollum ED, Fitzgerald E, Kamthunzi P, Schmicker RH, May S, Phiri M, Chirombo C, Phiri A, Ginsburg AS. Chest radiography in children aged 2-59 months enrolled in the Innovative Treatments in Pneumonia (ITIP) project in Lilongwe Malawi: a secondary analysis. BMC Pediatr. 2022 Jan 10;22(1):31. doi: 10.1186/s12887-021-03091-3.
• May S, Brown SP, Schmicker RH, Emerson SS, Nkwopara E, Ginsburg AS. Non-inferiority designs comparing placebo to a proven therapy for childhood pneumonia in low-resource settings. Clin Trials. 2020 Apr;17(2):129-137. doi: 10.1177/1740774519888460. Epub 2019 Dec 8.
• Nkwopara E, Schmicker R, Mvalo T, Phiri M, Phiri A, Couasnon M, McCollum ED, Ginsburg AS. Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi. BMJ Open Respir Res. 2019 Sep 3;6(1):e000415. doi: 10.1136/bmjresp-2019-000415. eCollection 2019.
• Ginsburg AS, Mvalo T, Nkwopara E, McCollum ED, Ndamala CB, Schmicker R, Phiri A, Lufesi N, Izadnegahdar R, May S. Placebo vs Amoxicillin for Nonsevere Fast-Breathing Pneumonia in Malawian Children Aged 2 to 59 Months: A Double-blind, Randomized Clinical Noninferiority Trial. JAMA Pediatr. 2019 Jan 1;173(1):21-28. doi: 10.1001/jamapediatrics.2018.3407.

Drugs

Indications