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