MedTrace Logo

A Trial of Intermittent Treatment in the Prevention of Malaria in Senegalese Children

NCT00132561 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2017-01-12

No results posted yet for this study

Summary

In countries of the Sahel and sub-Sahel, malaria transmission is highly seasonal with nearly all infections occurring during a few months of the year. However, mortality and morbidity from malaria may be high during this period, especially in young children who are the group most at risk.

Intermittent preventative treatment (IPT) is a new approach to the prevention of malaria in this situation. IPT involves the administration of an anti-malarial to children at risk for malaria at fixed times, even if they are not infected. To investigate how effective this approach might be in Senegal, a trial has been undertaken in which 1136 children aged 6 weeks to 59 months were given a single dose of sulfadoxine pyrimethamine and artesunate on three occasions during a three-month rainy season and the incidence of clinical malaria in these children was compared with that in a group of children who received placebo. Additional observations were made on the incidence of side effects in children in the two groups and on the impact of IPT in children (IPTc) on markers of drug resistance in children whose blood films were positive for Plasmodium falciparum.

Conditions

Interventions

DRUG

Sulfadoxine/pyrimethamine and artesunate

Sponsors & Collaborators

  • Institut de Recherche pour le Developpement, Senegal

    collaborator OTHER

  • Institut de Recherche pour le Developpement

    collaborator OTHER_GOV

  • Cheikh Anta Diop University, Senegal

    collaborator OTHER

  • Ministry of Health, Senegal

    collaborator OTHER_GOV

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Badara Cisse, MD · Institut de Recherche pour le Developpement, Senegal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Weeks
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-06-30
Completion
2003-12-31

Countries

  • Senegal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00132561 on ClinicalTrials.gov