Malaria
Conditions
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.
Interventions
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Inclusion criteria
* Children from study area * Signed informed consent
Exclusion criteria
* History of drug allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of first or only malaria episodes in each study cohort by 12 months of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of first or only malaria episodes by group up to 24 months of age. | — |
| Incidence of multiple malaria episodes up to 12 months of age. | — |
| Incidence of multiple malaria episodes up to 24 months of age. | — |
| Incidence of overall and severe anaemia up to 12 months of age. | — |
| Incidence of overall and severe anaemia up to 24 months of age. | — |
| Incidence of first or only malaria episodes by group up to 12 months of age as per protocol analysis. | — |
| Total number of admissions and outpatient attendances up to 24 months of age. | — |
| Prevalence of P falciparum parasitaemia and overall and severe anaemia at 12 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 side effects in each group up to 12 months of age. | — |
| Proportion of humoral and cellular immune responses against malaria at 12 months of age. | — |
Countries
Mozambique
Outcome results
None listed