drugset / Trial / NCT00111163
Intermittent Preventive Treatment With Antimalarials in Kenyan Infants
Completed
1516 enrolled
Centers for Disease Control and Prevention
Bill and Melinda Gates Foundation · collabKenya Medical Research Institute · collab
RandomizedSingle-groupDouble-blindPrevention
Summary
The purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life.
Timeline
- Start
- 2004-03
- Primary completion
- 2006-03
- Completion
- 2008-03
Outcome
Mixed primary results
paper The protective efficacy (PE) and 95% confidence intervals against the primary endpoint were: 25.7% (6.3, 41.1); 25.9% (6.8, 41.0); and 16.3% (-5.2, 33.5) PMID 20368815 ↗
paper in the SP-AS3, AQ3-AS3, and CD3 groups, respectively. PMID 20368815 ↗
Publications
- Background Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7. doi: 10.1016/S0140-6736(00)04643-2.
- Background Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Ronn AM, Theander TG, Bygbjerg IC. Effect of intermittent treatment with amodiaquine on anaemia and malarial fevers in infants in Tanzania: a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1853-60. doi: 10.1016/s0140-6736(03)13504-0.
- Odhiambo FO, Hamel MJ, Williamson J, Lindblade K, ter Kuile FO, Peterson E, Otieno P, Kariuki S, Vulule J, Slutsker L, Newman RD. Intermittent preventive treatment in infants for the prevention of malaria in rural Western kenya: a randomized, double-blind placebo-controlled trial. PLoS One. 2010 Apr 2;5(4):e10016. doi: 10.1371/journal.pone.0010016.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artesunate | Small molecule | — | — |
| Subject | Dapsone | Small molecule | — | — |
| Subject | Sulfadoxine-pyrimethamine | Small molecule | — | — |
| Subject | amodiaquine | Other / unclassified | — | — |
| Subject | chlorproguanil | Small molecule | — | — |