IPTi in Mozambican Infants for Malaria Prevention

Phase 1

• Conditions: Malaria

• Registration Number: NCT00209794
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-21
• Study Completion: 2005-12
• Status Verified: 2006-11
• Last Update Submitted: 2006-11-15
• Last Update Posted: 2006-11-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1498

Inclusion Criteria

• Children from study area
• Signed informed consent

Exclusion Criteria

• History of drug allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of first or only malaria episodes in each study cohort by 12 months of age.

Secondary Outcome Measures

Name	Time	Method
Incidence of multiple malaria episodes up to 12 months of age.
Incidence of multiple malaria episodes up to 24 months of age.
Incidence of side effects in each group up to 12 months of age.
Incidence of overall and severe anaemia up to 12 months of age.
Prevalence of P falciparum parasitaemia and overall and severe anaemia at 12 months of age.
Proportion of humoral and cellular immune responses against malaria at 12 months of age.
Total number of admissions and outpatient attendances up to 24 months of age.
Proportion of humoral responses and geometric mean antibody titres of polio, DTP and Hepatitis B at 5 months and of measles at 9 and 12 months
Incidence of first or only malaria episodes by group up to 12 months of age as per protocol analysis.
Incidence of first or only malaria episodes by group up to 24 months of age.
Incidence of overall and severe anaemia up to 24 months of age.

Trial Locations

Locations (1)

Centro de Investigaçao em Saude da Manhiça; 🇲🇿 Manhiça, Maputo, Mozambique