NCT00209794

IPTi in Mozambican Infants for Malaria Prevention

The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,498 (planned)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 3 Months
• Healthy volunteers: —

Summary

To evaluate if intermittent preventive treatment in infants (IPTi) consisting of SP \[Fansidar\] given through the EPI scheme alongside routine immunisations at 3, 4 and 9 months of age reduces de incidence of clinical malaria up to 12 months of age

Detailed description

The study is a randomised, double blind, placebo-controlled trial of the antimalarial drug sulphadoxine-pyrimethamine administered intermittently at 3, 4 and 9 months of age through the EPI scheme at the time of routine immunisations. Children will be randomized into placebo and SP treatment groups by block randomization, and it is expected a similar age distribution and a similar number of children in each group. Doses of sulphadoxine (25 mg/kg)-pyrimethamine (1.25 mg/kg) (SP) or placebo will be given by a health assistant according to bodyweight (a quarter of a tablet for those \<5kg, a half for those 5-10 kg, and a whole tablet for children \>10 kg). The tablets will be crashed and diluted with water for their administration.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Sulfadoxine-Pyrimethamine (Fansidar)

Timeline

• Start date: 2002-09-01
• Completion: 2005-12-01
• First posted: 2005-09-21
• Last updated: 2006-11-16

Locations

1 site across 1 country: Mozambique