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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mefloquine | Experimental | 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 |
|
| S/P | Placebo Comparator | sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mefloquine | Drug | 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Schweitzer Hospital | Lambaréné | Moyen-Ogooué Province | BP 115 | Gabon | ||
| Albert Schweitzer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33998661 | Derived | Salam RA, Das JK, Bhutta ZA. Effect of mass deworming with antihelminthics for soil-transmitted helminths during pregnancy. Cochrane Database Syst Rev. 2021 May 17;5(5):CD005547. doi: 10.1002/14651858.CD005547.pub4. | |
| 23175561 | Derived | Basra A, Mombo-Ngoma G, Melser MC, Diop DA, Wurbel H, Mackanga JR, Furstenau M, Zoleko RM, Adegnika AA, Gonzalez R, Menendez C, Kremsner PG, Ramharter M. Efficacy of mefloquine intermittent preventive treatment in pregnancy against Schistosoma haematobium infection in Gabon: a nested randomized controlled assessor-blinded clinical trial. Clin Infect Dis. 2013 Mar;56(6):e68-75. doi: 10.1093/cid/cis976. Epub 2012 Nov 21. |
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| ID | Term |
|---|---|
| D012553 | Schistosomiasis haematobia |
| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D015767 | Mefloquine |
| ID | Term |
|---|---|
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| S/P | Drug | sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations |
|
| Lambaréné |
| Gabon |
| D007239 |
| Infections |
| D014552 | Urinary Tract Infections |
| D000079426 | Vector Borne Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |