Ethiopia Antimalarial in Vivo Efficacy Study 2012

Summary

The investigators hypothesize that the addition of primaquine (PQ) to both artemether-lumefantrine (AL) and chloroquine (CQ) for the treatment of Plasmodium vivax infection will result in decreased chance of relapse by about 60%. The investigators plan to assess the therapeutic efficacy of AL compared to combined AL + PQ and CQ compared to combined CQ + PQ against P. vivax infection. They also plan to determine the number of recurrent vivax episodes in patients receiving PQ compared to those who don't receive PQ. Patients aged above 1 year with symptomatic malaria presenting to health centers will be enrolled for treatment with AL, AL+PQ, CQ, or CQ+PQ for P. vivax infection. Phase 1 of the study will monitor the clinical, parasitological, and hematological parameters for P. vivax infection over a 42-day follow-up period, which will be used to evaluate drug efficacy. Phase 2 will continue monthly follow-up of these patients for one year to assess frequency of recurring vivax infections. Results from this research study will be used to assist Ethiopia in assessing their current national malaria drug policies.

Timeline

Start

2012-10

Primary completion

2014-12

Completion

2014-12

Publications

• Kleinecke M, Sutanto E, Rumaseb A, Hoon KS, Trimarsanto H, Osborne A, Manrique P, Peters T, Hawkes D, Benavente ED, Whitton G, Siegel SV, Pearson RD, Amato R, Rai A, Nhien NTT, Nguyen HC, Assefa A, Degaga TS, Abate DT, Rahim AG, Pasaribu AP, Sutanto I, Alam MS, Pava Z, Lopera-Mesa T, Echeverry D, William T, Anstey NM, Grigg MJ, Day NP, White NJ, Kwiatkowski DP, Taylor AR, Noviyanti R, Neafsey D, Price RN, Auburn S. Microhaplotype deep sequencing assays to capture Plasmodium vivax infection lineages. Nat Commun. 2025 Aug 5;16(1):7192. doi: 10.1038/s41467-025-62357-x.
• Abreha T, Hwang J, Thriemer K, Tadesse Y, Girma S, Melaku Z, Assef A, Kassa M, Chatfield MD, Landman KZ, Chenet SM, Lucchi NW, Udhayakumar V, Zhou Z, Shi YP, Kachur SP, Jima D, Kebede A, Solomon H, Mekasha A, Alemayehu BH, Malone JL, Dissanayake G, Teka H, Auburn S, von Seidlein L, Price RN. Comparison of artemether-lumefantrine and chloroquine with and without primaquine for the treatment of Plasmodium vivax infection in Ethiopia: A randomized controlled trial. PLoS Med. 2017 May 16;14(5):e1002299. doi: 10.1371/journal.pmed.1002299. eCollection 2017 May.

Drugs

Indications