Clinical Trial: Activity of Mefloquine Against Urinary Schistosomiasis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Activity of Mefloquine Against Urinary Schistosomiasis
Brief Summary: Urinary schistosomiasis is a debilitating disease in Central Africa and pregnant women are frequently suffering from this condition. Mefloquine is currently investigated as preventive treatment against malaria in pregnancy and mefloquine is also known to exert activity against schistosomiasis. The investigators want to test the hypothesis whether mefloquine may active against urinary schistosomiasis when used as preventive treatment against malaria in pregnancy.
Detailed Summary:
Objectives
The principal aim of this clinical trial is to evaluate whether mefloquine - when given as intermittent preventive treatment against malaria in pregnancy - shows in vivo activity against concomitant Schistosoma haematobium infection. This study is therefore a "proof of principle" study and is not intended to establish a clinically satisfying cure rate or to formally compare the efficacy of mefloquine with the standard therapy.
Hypothesis
Two underlying hypotheses have been formulated for this proof of principle study.
Primary hypothesis: Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp Secondary hypothesis: Mefloquine may lead to an adequate cure rates of Schistosoma haematobium infections compared to S/P (>80%)
Trial Design
The evaluation of mefloquine activity against S. haematobium will be evaluated in the course of an open label multicenter randomized controlled trial assessing the efficacy, tolerability, and safety of mefloquine IPTp against malaria. This study is therefore a nested randomized controlled trial taking advantage of the randomization and treatment allocation procedures of the IPTp trial and assessing the additional efficacy outcome of reduction of S. haematobium egg excretion.
Sponsor: Albert Schweitzer Hospital
Current Primary Outcome: Reduction of egg excretion [ Time Frame: 6 weeks after second IPTp ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Cure rate [ Time Frame: 6 weeks after first and second IPTp ]
Original Secondary Outcome: Same as current
Information By: Albert Schweitzer Hospital
Dates:
Date Received: May 27, 2010
Date Started: May 2010
Date Completion:
Last Updated: January 23, 2013
Last Verified: January 2013