Activity of Mefloquine Against Urinary Schistosomiasis

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Activity of Mefloquine Against Urinary Schistosomiasis

Conditions
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Urinary Schistosomiasis

Intervention / Treatment
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* Drug: Mefloquine
* Drug: S/P


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women after first trimester and before 28th week of pregnancy HIV negative Egg excretion of Schistosoma haematobium (mean >10 eggs per mL urine) Asymptomatic (no signs of complicated Schistosomiasis, no severe anemia) Ability to comply with study protocol Exclusion Criteria: Intake of anthelminthic or antimalarial drug within 2 months prior to inclusion Allergy to study drugs
Sexes Eligible for Study
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Female

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mefloquine<br>15mg/kg mefloquine per dose Women receive two doses: One after the first trimester of pregnancy and the second at least one month after the first dose | Drug: Mefloquine<br>* 15mg/kg mefloquine per dose Women receive two doses: One after the first trimester of pregnancy and the second at least one month after the first dose<br>|
| Placebo Comparator: S/P<br>sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations | Drug: S/P<br>* sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of egg excretion | Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp | 6 weeks after second IPTp | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate | Mefloquine may lead to an adequate cure rates of Schistosoma haematobium infections compared to S/P (>80%) | 6 weeks after first and second IPTp | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schistosomiasis, schistosoma haematobium