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IPTi in Mozambican Infants for Malaria Prevention

H

Hospital Clinic of Barcelona

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Malaria

Treatments

Drug: Sulfadoxine-Pyrimethamine (Fansidar)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

Under 3 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children from study area
  • Signed informed consent

Exclusion criteria

  • History of drug allergies

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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