The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Malaria
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 1498
- Locations
- 1
- Primary Endpoint
- Incidence of first or only malaria episodes in each study cohort by 12 months of age.
- Last Updated
- 19 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children from study area
- •Signed informed consent
Exclusion Criteria
- •History of drug allergies
Outcomes
Primary Outcomes
Incidence of first or only malaria episodes in each study cohort by 12 months of age.
Secondary Outcomes
- 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.