Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Sulfadoxine-Pyrimethamine in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children in Lambaréné

Conditions
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Malaria

Intervention / Treatment
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* Drug: Sulfadoxine Pyrimethamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female outpatients Aged 6 to 59 months Body weight between 7.5 to 30 kg uncomplicated falciparum malaria with parasitaemia between 1,000/µL and 200,000/µL Ability to tolerate oral therapy Informed consent, oral agreement of the child if appropriate Exclusion Criteria: Still in IPTi trial and/or still in any other intervention trial Known G6PD-deficiency Presence of severe malnutrition Inability to drink or breastfeed Recent history of convulsions, lethargy or unconsciousness; Signs of severe and complicated Mixed/mono infection that includes a non-P. falciparum species. Hb < 7g/dl Inability to attend stipulated follow-up visits. History of hypersensitivity reactions to the drug being evaluated

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sulfadoxine Pyrimethamine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the clinical and parasitological efficacy of SP among patients aged between 6-59 months suffering from uncomplicated P falciparum malaria, |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the frequency of molecular markers for drug resistance |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sulfadoxine, Malaria, Pyrimethamine, Resistance, Gabon