drugset / Trial / NCT00868465

Treatment Efficacy and Malaria TRANSmission After Artemisinin Combination Therapy (TRANSACT)

NCT00868465

RandomizedParallel-groupTriple-blindTreatment

Summary

Artemisinin combination therapy (ACT) with artemether lumefantrine (AL) is currently the first line treatment policy in Tanzania. AL is an efficacious drug that also has the capacity to reduce malaria transmission to mosquitoes. Nevertheless, there is concern about the development of parasite resistance against AL and there have been very few clinical trials that compared different ACT regimens. A recent clinical trial shows that the combination of dihydroartemisinin-piperaquine (DP) may be more efficacious than AL and may have a more pronounced beneficial effect on post-treatment malaria transmission. Screening for molecular markers that are related to parasite susceptibility to ACT drugs and to post-ACT treatment malaria transmission can assist in preventing the development and spread of ACT resistance. In the current study, the investigators compared AL and DP for the treatment of uncomplicated malaria. The investigators endpoints are * clinical efficacy * post-treatment gametocytaemia by molecular techniques * post-treatment malaria transmission.

Timeline

Start
2009-04
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject ARTENIMOL Small molecule 2.5 mg/kg
Comparator Artemether Small molecule 20 mg
Comparator lumefantrine Small molecule 120 mg
Subject piperaquine Small molecule 20 mg/kg

Indications