Seasonal Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine in Children in Mali

Study Overview
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Brief Summary
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Recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (IPT) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. However, in countries such as Mali, where malaria is highly seasonal and prevalent in older children, IPT in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. An alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. Here we propose (i) to evaluate the impact of two seasonal IPT (sIPT) with Sulfadoxine-pyrimethamine (SP) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in Kambila, Mali; (ii) to assess the impact of this strategy on the in vivo response of P. falciparum to SP; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. Children 6 months-10 years in Kambila, Mali will randomized to receive either IPT with SP twice at 8 weeks interval or no IPT during the transmission season and will followed up for 12 months. Subjects will be also followed during the subsequent transmission season to assess possible rebound effect. Clinical malaria cases will be treated with SP and followed for 28 days to assess the in vivo response during both periods.

Official Title
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Evaluation of a Malaria Transmission Target Strategy Based on the Periodic Treatment With Sulfadoxine-Pyrimethamine vs. Early Case Management

Conditions
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Malaria

Intervention / Treatment
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* Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6 months to 10 years Agree to seek initial medical care for all medical illness in the study clinic during the study period Written informed consent by a parent or legal garden, No plan to travel for a long time during the study period. Exclusion Criteria: History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine Chronic illness or symptomatic malaria at the time of enrollment

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Control group | |
| Experimental: 2<br>Test group | Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine<br>* Subjecs randomized to receive two intermittent preventive treatments with standard recommended treatment doses of Sulfadoxine-pyrimethamine at 8 weeks interval during the peak malaria transmission season.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence rate of clinical malaria |  |  | 
| in vivo adequate clinical and parasitological response of P. falciparum to SP |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malaria, intermittent preventive treatment, season, children