Urinary Schistosomiasis Clinical Trial
Official title:
Activity of Mefloquine Against Urinary Schistosomiasis
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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