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

Not Applicable

Completed

• Conditions: Malaria
• Interventions: Drug: Seasonal IPT in children - Sulfadoxine-pyrimethamine

• Registration Number: NCT00623155
• Lead Sponsor: University of Bamako

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Status Verified: 2002-09
• Primary Completion: 2003-07
• Study Completion: 2004-01
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-22
• Last Update Submitted: 2008-02-22
• Study First Posted: 2008-02-25
• Last Update Posted: 2008-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Seasonal IPT in children - Sulfadoxine-pyrimethamine	Test group

Primary Outcome Measures

Name	Time	Method
incidence rate of clinical malaria
in vivo adequate clinical and parasitological response of P. falciparum to SP

Trial Locations

Locations (1)

Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako; 🇲🇱 Bamako, Mali