drugset / Trial / NCT00361114

IPT and Efficacy of Sulphadoxine/Pyrimethamine and Chlorproguanil/Dapsone in 6-59 Month Old Children With Malaria.

NCT00361114

Phase 3 Terminated 112 enrolled London School of Hygiene and Tropical Medicine
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Intermittent Preventive Treatment of malaria in infants is a promising strategy to reduce incidence of clinical malaria in children under the age of 1 year. It is likely to be implemented as a malaria control strategy in Tanzania using sulfadoxine/pyremethamine SP. SP is failing as a first line treatment for clinical episodes of malaria and government policy is driving a change to use Artemesin Combination Therapy (ACT). The main ongoing Kilimanjaro IPTi study is looking at alternatives to SP for use in IPTi. Currently, as there is no evidence for the use of other drugs for IPT, SP will be continued for IPT in pregnancy and in infants. This study proposes to measure the efficacy of SP and chlorproguanil/dapsone (CD), in symptomatic 6- 59 month old children using standard methodology. These are both study drugs in the main IPTi study. This will help us to see how the efficacies of SP and CD in sick children relate to the efficacies for treating asymptomatic children with IPTi. In addition this proposal aims to test the efficacy of SP given to 2-10 month old asymptomatic infants (the target group for IPTi). Evidence suggests that asymptomatic malaria infections with low parasitaemia have a higher cure rate than symptomatic infections with high parasitaemia even when markers of resistance are highly prevalent. This second study aims to quantify this difference and will produce evidence to help policy makers know when drugs used for IPTi should be changed. Both studies will be open label and run concurrently in Hale, Korogwe district near to the main Kilimanjaro IPTi site in Tanzania.

Timeline

Start
2006-07
Primary completion
2007-08
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapsone Small molecule 18.75 mg
Subject Dapsone Small molecule 28.125 mg
Subject Dapsone Small molecule 37.5 mg
Subject Dapsone Small molecule 46.875 mg
Subject Dapsone Small molecule 93.75 mg
Subject chlorproguanil Small molecule 15 mg
Subject chlorproguanil Small molecule 22.5 mg
Subject chlorproguanil Small molecule 30 mg
Subject chlorproguanil Small molecule 37.5 mg
Subject chlorproguanil Small molecule 75 mg
Comparator pyrimethamine Small molecule 7.5 mg
Comparator pyrimethamine Small molecule 15 mg
Comparator pyrimethamine Small molecule 22.5 mg
Comparator sulfadoxine Small molecule 250 mg
Comparator sulfadoxine Small molecule 500 mg
Comparator sulfadoxine Small molecule 750 mg

Indications