3 Days Versus 5 Days Amoxicillin for Chest-indrawing Childhood Pneumonia in Malawi

Summary

This clinical trial evaluates the duration of treatment of chest-indrawing pneumonia in children. Half the children will receive 3 days of amoxicillin dispersible tablets (DT) and then 2 days of placebo, while the other half will receive 5 days of amoxicillin DT.

Timeline

Start

2016-03

Primary completion

2019-04

Completion

2019-12

Outcome

Met primary endpoint

paper In HIV-uninfected Malawian children, treatment with amoxicillin for chest-indrawing pneumonia for 3 days was noninferior to treatment for 5 days. PMID 32609979 ↗

Publications

• Ginsburg AS, May S. Analysis of serious adverse events in a pediatric community-acquired pneumonia randomized clinical trial in Malawi. Sci Rep. 2022 Mar 3;12(1):3538. doi: 10.1038/s41598-022-07582-w.
• 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.
• Ginsburg AS, Mvalo T, Nkwopara E, McCollum ED, Phiri M, Schmicker R, Hwang J, Ndamala CB, Phiri A, Lufesi N, May S. Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children. N Engl J Med. 2020 Jul 2;383(1):13-23. doi: 10.1056/NEJMoa1912400.
• Ginsburg AS, May SJ, Nkwopara E, Ambler G, McCollum ED, Mvalo T, Phiri A, Lufesi N, Sadruddin S. Methods for conducting a double-blind randomized controlled clinical trial of three days versus five days of amoxicillin dispersible tablets for chest indrawing childhood pneumonia among children two to 59 months of age in Lilongwe, Malawi: a study protocol. BMC Infect Dis. 2018 Sep 21;18(1):476. doi: 10.1186/s12879-018-3379-z.

Drugs

Indications