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Activity of Mefloquine Against Urinary Schistosomiasis

Information source: Albert Schweitzer Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Schistosomiasis

Intervention: Mefloquine (Drug); S/P (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Albert Schweitzer Hospital


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.

Clinical Details

Official title: Activity of Mefloquine Against Urinary Schistosomiasis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Reduction of egg excretion

Secondary outcome: Cure rate

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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Female.


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

Locations and Contacts

Albert Schweitzer Hospital, Lambarene, Gabon

Albert Schweitzer Hospital, Lambaréné, Moyen Ogooue BP 115, Gabon

Additional Information

Starting date: May 2010
Last updated: January 23, 2013

Page last updated: August 23, 2015

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