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Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children

NCT00453856 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2007-08-10

No results posted yet for this study

Summary

IPTi, a strategy whereby infants are provided treatment doses of antimalarials at routine vaccination visits, has been shown to significantly reduce malaria and anemia in two studies in Tanzania. However the results obtained in Gabon are not similar. Many factors are likely to influence the efficacy or effectiveness IPTi. It is reasonable to assume that the efficacy of IPTi will be influenced markedly by the sensitivity of Plasmodium falciparum to the antimalarial drug (Sulfadoxine-Pyrimethamine) used for IPTi.

In order to interpret the results of individual IPTi trials conducted by the IPTi Consortium, and to provide information for policy makers regarding the predicted efficacy of IPTi, it is essential to obtain information on antimalarial drug sensitivity of Sulfadoxine-Pyrimethamine now that the IPTi trial has been conducted. The simplest and most universally accepted measure of testing for antimalarial drug efficacy is the "in vivo efficacy study," which follows a standardized World Health Organization protocol.

A second reason for evaluating drug resistance as an adjunct to the IPTi trials is to determine if the intervention increases the carriage and/or spread of drug resistant P. falciparum parasites.

Thirdly the overall effect at the community level of selection of resistant genotypes in IPTi-recipients is unclear.

Conditions

Interventions

DRUG

Sulfadoxine Pyrimethamine

Sponsors & Collaborators

  • Albert Schweitzer Hospital

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Albert Schweitzer Hospital, Netherlands

    lead UNKNOWN

Principal Investigators

  • Martin P Grobusch, MD · Medical Research Unit, Albert Schweitzer Hospital Lambaréné

  • Saadou Issifou, MD MSc · Albert Schweitzer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31

Countries

  • Gabon

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 NCT00453856 on ClinicalTrials.gov