IPTi in Mozambican Infants for Malaria Prevention

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malaria

Intervention / Treatment
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* Drug: Sulfadoxine-Pyrimethamine (Fansidar)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children from study area Signed informed consent Exclusion Criteria: History of drug allergies

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sulfadoxine-Pyrimethamine (Fansidar)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of first or only malaria episodes in each study cohort by 12 months of age. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. |  |  | 
| 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. |  |  | 
| 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. |  |  |