IPTi in Mozambican Infants for Malaria Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1498 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2005-12-31

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.

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Sulfadoxine-Pyrimethamine (Fansidar)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children from study area
* Signed informed consent

Exclusion Criteria

* History of drug allergies

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Clara Menendez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for International Health, Hospital Clinic de Barcelona

Locations

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Centro de Investigaçao em Saude da Manhiça

Manhiça, Maputo Province, Mozambique

Site Status

Countries

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Mozambique

References

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Mayor A, Serra-Casas E, Sanz S, Aponte JJ, Macete E, Mandomando I, Puyol L, Berzosa P, Dobano C, Aide P, Sacarlal J, Benito A, Alonso P, Menendez C. Molecular markers of resistance to sulfadoxine-pyrimethamine during intermittent preventive treatment for malaria in Mozambican infants. J Infect Dis. 2008 Jun 15;197(12):1737-42. doi: 10.1086/588144.

Reference Type DERIVED

PMID: 18419347 (View on PubMed)

Other Identifiers

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TIM

Identifier Type: -

Identifier Source: org_study_id