Activity of Mefloquine Against Urinary Schistosomiasis

Phase 2

Completed

• Conditions: Urinary Schistosomiasis
• Interventions: Drug: S/P; Drug: Mefloquine

• Registration Number: NCT01132248
• Lead Sponsor: Albert Schweitzer Hospital

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 Description

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-27
• Study First Posted: 2010-05-28
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S/P	S/P	sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations
Mefloquine	Mefloquine	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

Primary Outcome Measures

Name	Time	Method
Reduction of egg excretion	6 weeks after second IPTp	Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp

Secondary Outcome Measures

Name	Time	Method
Cure rate	6 weeks after first and second IPTp	Mefloquine may lead to an adequate cure rates of Schistosoma haematobium infections compared to S/P (\>80%)

Trial Locations

Locations (1)

Albert Schweitzer Hospital; 🇬🇦 Lambarene, Gabon