The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission

Hospital Clinic of Barcelona1 site in 1 country832 target enrollmentFebruary 1995

ConditionsMalaria Anemia

DrugsDeltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)iron (2 mg/kg/daily)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Malaria
Sponsor: Hospital Clinic of Barcelona
Enrollment: 832
Locations: 1
Primary Endpoint: Severe Anemia (PCV < 25%)
Status: Terminated
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission

Detailed Description

411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprim™ (3.125 mg pyrimethamine plus 25 mg dapsone) or placebo from ages 2-12 months. Children were followed-up until age 4 years. Uncomplicated febrile malaria, severe malaria and anaemia morbidity were assessed through hospital-based passive surveillance.

Registry

clinicaltrials.gov

Start Date

February 1995

End Date

July 1999

Last Updated

18 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Hospital Clinic of Barcelona

Eligibility Criteria

Inclusion Criteria

•Born in San Francis Designated District Hospital of Ifakara

Exclusion Criteria

•Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus
•Birth weight \< 1,5 kg
•Clinical signs of cerebral asphyxia
•Clinical signs of neonatal or congenital infection
•Mother unreliable (deaf, mentally handicapped)