A Trial of Four Drug Regimens for the Prevention of Malaria in Senegalese Children

Phase 3 Completed 2200 enrolled London School of Hygiene and Tropical Medicine Cheikh Anta Diop University, Senegal · collab Institut de Recherche pour le Developpement, Senegal · collab Ministry of Health, Senegal · collab

RandomizedSingle-groupSingle-blindPrevention

Summary

A recent study has shown that the administration of a single dose of sulfadoxine/pyrimethamine plus artesunate to Senegalese children on three occasions during a short malaria transmission season reduced the incidence of clinical attacks of malaria by 86%. However, use of this drug regimen led to the selection of parasites with molecular markers of resistance to pyrimethamine and sulfadoxine. Therefore, a trial of three alternative regimens has been undertaken to see if these are as effective and safe as the drug combination used in the initial study but less likely to select for drug resistance.

Timeline

Start: 2004-06
Primary completion: —
Completion: 2004-12

Outcome

Met primary endpoint

paper incidence of malaria, and the prevalence of parasitaemia at the end of the transmission season, were lowest in the group that received SP+3AQ PMID 18213379 ↗

paper SP+3AQ group, HR 0.50 (0.30-0.81). PMID 18213379 ↗

Publications

Sokhna C, Cisse B, Ba el H, Milligan P, Hallett R, Sutherland C, Gaye O, Boulanger D, Simondon K, Simondon F, Targett G, Lines J, Greenwood B, Trape JF. A trial of the efficacy, safety and impact on drug resistance of four drug regimens for seasonal intermittent preventive treatment for malaria in Senegalese children. PLoS One. 2008 Jan 23;3(1):e1471. doi: 10.1371/journal.pone.0001471.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Artesunate	Small molecule	—	—
Subject	amodiaquine	Other / unclassified	—	—
Subject	pyrimethamine	Small molecule	—	—
Subject	sulfadoxine	Small molecule	—	—