Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children
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|ClinicalTrials.gov Identifier: NCT00453856|
Recruitment Status : Terminated (The study was terminated because of Early Treatment Failure in child.The justification for this decision are concerns about safety of children.)
First Posted : March 29, 2007
Last Update Posted : August 10, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Sulfadoxine Pyrimethamine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||139 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Sulfadoxine-Pyrimethamine in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children in Lambaréné|
|Study Start Date :||March 2007|
- Measure the clinical and parasitological efficacy of SP among patients aged between 6-59 months suffering from uncomplicated P falciparum malaria,
- Determine the frequency of molecular markers for drug resistance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453856
|Medical Research Unit of the Albert Schweitzer Hospital|
|Lambaréné, Moyen Ogooué, Gabon, B.P. 118|
|Study Director:||Martin P Grobusch, MD||Medical Research Unit, Albert Schweitzer Hospital Lambaréné|
|Principal Investigator:||Saadou Issifou, MD MSc||Albert Schweitzer Hospital|