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

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Methodology:

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.

Clinical trial registration

Drug-based Strategies
Impact of Interventions
Vulnerable Populations

Aug 2006 — Jan 2017

Tanzania

Intermittent preventive treatment in infants (IPTi)