Malaria Clinical Trial
Official title:
Efficacy of Sulfadoxine-Pyrimethamine in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children in Lambaréné
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.
Administration of standard single oral dose of sulfadoxine-pyrimethamine to children aged
6-59 month old children in Lambaréné at enrolment, if eligible according to the approved
protocol.
139 subjects will be enrolled and treated with Sulfadoxine-Pyrimethamine for uncomplicated
malaria. Thereafter each subject will be followed according to the approved protocol
The proportion of subjects with Adequate Clinical and Parasitological response (ACPR) by day
28, Early Treatment Failure (ETF), Late Clinical Failure (LCF) and Late Parasitological
Failure (LPF)will be evaluated.
secondly the frequency of molecular markers for Sulfadoxine-Pyrimethamine drug resistance
will be determined.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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