drugset / Trial / NCT00944840

Intermittent Preventive Treatment (IPTc) and Home Based Management of Malaria (HMM)in The Gambia

NCT00944840

Phase 3 Completed 1312 enrolled London School of Hygiene and Tropical Medicine
RandomizedSingle-groupOpen-labelPrevention

Summary

Malaria in African countries remains an important cause of mortality and morbidity among young children. The global malaria control strategies include prompt treatment with an effective antimalarial drug, vector control using ITNs or curtains, indoor residual spraying (IRS), and intermittent preventive treatment. However, individually these interventions provide only imperfect protection. Thus, there is a need to investigate whether additional control measures provide added benefit in reducing mortality and morbidity. Therefore, 1312 children under 5 years of age living in villages and hamlets near Farafenni, The Gambia, which form part of the rural Farafenni Demographic Surveillance system (FDSS) in North Bank Region(NBR) were randomly allocated to receive IPTc or placebo from village health workers based in primary health care villages. Treatment with a single dose of sulfadoxine /pyrimethamine plus three doses of amodiaquine or placebo was given to all study subjects at monthly intervals on three occasions during the months of September, October and November. In addition, VHWs were trained to administer treatment with coartem to children if they develop symptoms compatible with malaria during the malaria transmission season. The primary end point was the incidence of clinical attacks of malaria detected during the study.

Timeline

Start
2008-09
Primary completion
2009-07
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator amodiaquine Other / unclassified
Comparator pyrimethamine Small molecule
Comparator sulfadoxine Small molecule

Indications