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Dr
Karim Traore

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Project Title

Research Capacity Building by DHA-PQ SMC Clinical Trial in school aged children in Mali

EDCTP Project

TMA2018SF-2471

EDCTP Program

EDCTP2

EDCTP Project Call

Senior Fellowship (SF)

Project Objectives

- Assess the impact of SMC on the incidence of clinical malaria and infection in school-aged children; - Evaluate the effect of SMC with DHA-PQ on malaria transmission, measured by the reduction in the prevalence of gametocytes in DHA-PQ treatment group; - Assess the impact of SMC on the genetic diversity of malaria parasites, measured by studying the dynamics of molecular markers associated with resistance to drugs used in SMC. - Evaluate the clinical tolerance of DHA-PQ compared to SP-AQ and control

Study Design

Interventional study, Phase IV randomized trial with 3 treatment arms: DHA-PQ vs. SP-AQ vs. Albendazole. The trial was randomized double-blinded controlled. Efficacy and tolerability of Dihydroartemisinin-Piperaquine compared to Sulfadoxine-Pyrimethamine associated to Amodiaquine in Seasonal Malaria Chemoprevention in school aged children from 6-15 years were assessed. Participants were followed for 12 months, 4 SMC rounds and 2 cross-sectional surveys were conducted.

Project Summary

Seasonal Malaria Chemoprophylaxis with Sulfadoxine-Pyrimethamine associated to Amodiaquine (SP-AQ) is a malaria control strategy that targets children aged 3-59 months in areas where 60% or more of malaria transmission and disease burden occur in the rainy season over a period of about 4 months. School-aged children are not currently targeted by SMC in all countries and constitute a neglected population afflicted by seasonal malaria in countries where SMC is implemented. Modelling studies indicates that scale up of malaria interventions with high impact on disease burden may lead to an age shift in malaria burden. Evidence from field trials indicates that extending the age range for SMC may lead to reduced transmission of malaria and could contribute to programs to eliminate malaria transmission. SP-AQ is the currently recommended regimen for SMC and SP is also used in intermittent preventive treatment (IPT) in pregnant women. Pyrimethamine is known to rapidly select DHFR gene mutations associated with drug resistance to SP, therefore, SP is threatened by the rise and spread of drug resistant parasites. Hence, there is a need to have alternative drug regimens for SMC. Dihydroartemisinin-Piperaquine (DHA-PQ) is a long acting artemisinin-based combination therapy that is recommended by WHO for first line cure of uncomplicated malaria. The aim of this study is to establish the efficacy, effectiveness and safety of a preventive intervention with DHA-PQ to reduce malaria burden in school-aged children.

Host Organisation

Department Institution Country
Malaria Research and Training Center USTTB Mali

Sites

Results & Outcomes

We screened a total of 385 volunteers of which 345 were successfully enrolled. Thus, 116 were randomized to SP-AQ arm, 114 to treatment DHA-PQ arm and 115 to control arm. All randomized patients successfully completed the first two rounds of SMC. Two patients in SP-AQ arm and one patient in control arm missed the third round. In the fourth round, as in the cross-sectional visit, 113 volunteers from SP-AQ arm, 114 from DHA-PQ arm and 114 from control arm were seen. At the last cross-sectional survey, 105 volunteers from SP-AQ arm, 109 from DHA-PQ arm and 112 from control arm were seen. The total rates of lost to follow-up were 1.15% at the 4th SMC rounds, and 5.5% at the end of the study (last cross-sectional survey).