Activity of Mefloquine Against Urinary Schistosomiasis
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ClinicalTrials.gov Identifier: NCT01132248 |
Recruitment Status
:
Completed
First Posted
: May 28, 2010
Last Update Posted
: January 24, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Schistosomiasis | Drug: Mefloquine Drug: S/P | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Activity of Mefloquine Against Urinary Schistosomiasis |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: 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
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Drug: 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
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Placebo Comparator: S/P
sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations
|
Drug: S/P
sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations
|
- Reduction of egg excretion [ Time Frame: 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
- Cure rate [ Time Frame: 6 weeks after first and second IPTp ]Mefloquine may lead to an adequate cure rates of Schistosoma haematobium infections compared to S/P (>80%)

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132248
Gabon | |
Albert Schweitzer Hospital | |
Lambaréné, Moyen Ogooue, Gabon, BP 115 | |
Albert Schweitzer Hospital | |
Lambarene, Gabon |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Michael Ramharter, Ass. Prof. PD, Albert Schweitzer Hospital |
ClinicalTrials.gov Identifier: | NCT01132248 History of Changes |
Other Study ID Numbers: |
IDC-2010-1 |
First Posted: | May 28, 2010 Key Record Dates |
Last Update Posted: | January 24, 2013 |
Last Verified: | January 2013 |
Keywords provided by Michael Ramharter, Albert Schweitzer Hospital:
schistosomiasis, schistosoma haematobium |
Additional relevant MeSH terms:
Schistosomiasis Schistosomiasis haematobia Trematode Infections Helminthiasis Parasitic Diseases Urinary Tract Infections Infection |
Urologic Diseases Fanasil, pyrimethamine drug combination Mefloquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |