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Sponsors and Collaborators: |
Albert Schweitzer Hospital Medical Research Unit, Lambaréné Bill and Melinda Gates Foundation |
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Information provided by: | Albert Schweitzer Hospital |
ClinicalTrials.gov Identifier: | NCT00453856 |
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 | Intervention | Phase |
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Malaria |
Drug: Sulfadoxine Pyrimethamine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Sulfadoxine-Pyrimethamine in the Treatment of Symptomatic, Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children in Lambaréné |
Estimated Enrollment: | 139 |
Study Start Date: | March 2007 |
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.
Ages Eligible for Study: | 6 Months to 59 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Gabon, Moyen Ogooué | |
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 | Medical Research Unit, Lambaréné |
Study ID Numbers: | IPTi-DRWG- SP Lambaréné |
Study First Received: | March 28, 2007 |
Last Updated: | August 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00453856 History of Changes |
Health Authority: | Gabon: Ministry of Health and Population |
Malaria Sulfadoxine Pyrimethamine Resistance Gabon |
Pyrimethamine Protozoan Infections Anti-Infective Agents Sulfadoxine-pyrimethamine Folate Malaria Anti-Infective Agents, Urinary Sulfadoxine |
Folic Acid Antagonists Folinic Acid Vitamin B9 Malaria, Falciparum Folic Acid Antimalarials Parasitic Diseases |
Pyrimethamine Protozoan Infections Anti-Infective Agents Sulfadoxine-pyrimethamine Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Anti-Infective Agents, Urinary Enzyme Inhibitors Malaria |
Renal Agents Folic Acid Antagonists Sulfadoxine Pharmacologic Actions Malaria, Falciparum Antimalarials Antiparasitic Agents Therapeutic Uses Parasitic Diseases |