Study Results
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Basic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2010-05-31
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
S/P
sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations
S/P
sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations
Interventions
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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
S/P
sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations
Eligibility Criteria
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Inclusion Criteria
* 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
* Allergy to study drugs
FEMALE
No
Sponsors
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Albert Schweitzer Hospital
OTHER
Responsible Party
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Michael Ramharter
Ass. Prof. PD
Locations
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Albert Schweitzer Hospital
Lambaréné, Moyen-Ogooué Province, Gabon
Albert Schweitzer Hospital
Lambaréné, , Gabon
Countries
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References
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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.
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.
Other Identifiers
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IDC-2010-1
Identifier Type: -
Identifier Source: org_study_id
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