Activity of Mefloquine Against Urinary Schistosomiasis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Albert Schweitzer Hospital
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Reduction of egg excretion
Study Overview
Brief 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.
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%)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- 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
Arms & Interventions
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
Intervention: Mefloquine (Drug)
S/P
sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations
Intervention: S/P (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Cure rate(6 weeks after first and second IPTp)
Investigators
Michael Ramharter
Ass. Prof. PD
Albert Schweitzer Hospital