IPT and Efficacy of Sulphadoxine / Pyrimethamine and Chlorproguanil / Dapsone in 6-59 Month Old Children With Malaria.
This project is part of a multicentre trial looking into antimalarial resistance within a series of Intermittent Preventive Treatment of malaria in Infants (IPTi) studies. And proposes to measure the efficacy of SP and chlorproguanil/dapsone (CD), in symptomatic 6- 59 month old children using standard methodology compare to SP. This second study aims to quantify this difference and will produce evidence to help policymakers know when drugs used for IPTi should be changed.
This project proposes 2 studies that have the following objectives:
- Enumerate the drug efficacies of SP and CD in the study area using the standard WHO in vivo drug efficacy methodology in symptomatic children aged 6-59 months
- Enumerate the efficacy of SP in asymptomatic 2 - 10 month olds using a modified WHO in vivo drug efficacy methodology, the target population for IPTi
- Determine the difference of efficacy when using SP for the different indications, ie between its use in symptomatic and asymptomatic children.
Intermittent Preventive Treatment of malaria in infants is a promising strategy to reduce the 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/pyrimethamine 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.
ClinicalTrials.gov Identifier: NCT00361114
Study Phase: Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study 1 is a standard in vivo WHO drug efficacy study looking at parasite positive symptomatic children between the ages of 6 and 59 months treated with SP or CD. They will be followed up after 1,2 3, 7,14,21 and 28 days. At each visit, a blood slide and filter paper will be collected. Endpoints are day 28 recrudescence rates.
Study 2 is a modified in vivo drug efficacy study in the age group directly affected by IPTi, namely 2-10 months of age. Asymptomatic children will be followed up at days 1, 2, 3,7,14, 21 and 28 only. The endpoint is day 28 recrudescence rate. Blood slide and filter paper will only be taken on day 7, 14 and 28 unless the child has a fever or has reported fever in the last 48 hours.