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PublishedInterventionalPhase 3

Longitudinal Antimalarial Combinations in Uganda

Longitudinal Comparison of Combination Antimalarial Therapies in Ugandan Children: Evaluation of Safety, Tolerability, and Efficacy

This is a registered study tracked in the Sterling IMRES research watch. It is sponsored by University of California, San Francisco and run by the investigators named in the registry, not by Sterling IMRES. Details come from ClinicalTrials.gov, last updated 9 June 2020.

Summary

This Phase 3 study followed a cohort of young children in Kampala, Uganda, treating each malaria episode with one of three randomised drug combinations: amodiaquine plus artesunate, amodiaquine plus sulfadoxine-pyrimethamine, or artemether-lumefantrine. Following children over time allowed comparison of efficacy and safety across repeated treatments. Several results papers are linked in the registry.

Objectives

  • Compare three combination treatments for uncomplicated malaria, including two artemisinin-based combinations, when used repeatedly in children.
  • Measure the annual incidence of malaria in each treatment arm in a Kampala cohort.

Methodology

Study design
Randomized, parallel assignment, single-blind, primary purpose: treatment
Conditions
Malaria
Interventions
Amodiaquine+Artesunate (drug); Amodiaquine+Sulfadoxine/Pyrimethamine (drug); Artemether+Lumefantrine (drug)
Primary outcome
Annual incidence of malaria per treatment arm
Sample size
601 participants (actual)
Locations
Uganda

Findings and resulting publications

  • Davis JC, Clark TD, Kemble SK, Talemwa N, Njama-Meya D, Staedke SG, Dorsey G. Longitudinal study of urban malaria in a cohort of Ugandan children: description of study site, census and recruitment. Malar J. 2006 Mar 21;5:18. doi: 10.1186/1475-2875-5-18. PubMed 16551365
  • Njama-Meya D, Clark TD, Nzarubara B, Staedke S, Kamya MR, Dorsey G. Treatment of malaria restricted to laboratory-confirmed cases: a prospective cohort study in Ugandan children. Malar J. 2007 Jan 21;6:7. doi: 10.1186/1475-2875-6-7. PubMed 17239256
  • Dorsey G, Staedke S, Clark TD, Njama-Meya D, Nzarubara B, Maiteki-Sebuguzi C, Dokomajilar C, Kamya MR, Rosenthal PJ. Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial. JAMA. 2007 May 23;297(20):2210-9. doi: 10.1001/jama.297.20.2210. PubMed 17519410
  • Clark TD, Greenhouse B, Njama-Meya D, Nzarubara B, Maiteki-Sebuguzi C, Staedke SG, Seto E, Kamya MR, Rosenthal PJ, Dorsey G. Factors determining the heterogeneity of malaria incidence in children in Kampala, Uganda. J Infect Dis. 2008 Aug 1;198(3):393-400. doi: 10.1086/589778. PubMed 18522503
  • Maiteki-Sebuguzi C, Jagannathan P, Yau VM, Clark TD, Njama-Meya D, Nzarubara B, Talisuna AO, Kamya MR, Rosenthal PJ, Dorsey G, Staedke SG. Safety and tolerability of combination antimalarial therapies for uncomplicated falciparum malaria in Ugandan children. Malar J. 2008 Jun 11;7:106. doi: 10.1186/1475-2875-7-106. PubMed 18547415
  • Staedke SG, Jagannathan P, Yeka A, Bukirwa H, Banek K, Maiteki-Sebuguzi C, Clark TD, Nzarubara B, Njama-Meya D, Mpimbaza A, Rosenthal PJ, Kamya MR, Wabwire-Mangen F, Dorsey G, Talisuna AO. Monitoring antimalarial safety and tolerability in clinical trials: a case study from Uganda. Malar J. 2008 Jun 11;7:107. doi: 10.1186/1475-2875-7-107. PubMed 18547416
  • Greenhouse B, Slater M, Njama-Meya D, Nzarubara B, Maiteki-Sebuguzi C, Clark TD, Staedke SG, Kamya MR, Hubbard A, Rosenthal PJ, Dorsey G. Decreasing efficacy of antimalarial combination therapy in Uganda is explained by decreasing host immunity rather than increasing drug resistance. J Infect Dis. 2009 Mar 1;199(5):758-65. doi: 10.1086/596741. PubMed 19199542
  • Clark TD, Njama-Meya D, Nzarubara B, Maiteki-Sebuguzi C, Greenhouse B, Staedke SG, Kamya MR, Dorsey G, Rosenthal PJ. Incidence of malaria and efficacy of combination antimalarial therapies over 4 years in an urban cohort of Ugandan children. PLoS One. 2010 Jul 30;5(7):e11759. doi: 10.1371/journal.pone.0011759. PubMed 20689585

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