Activity of Mefloquine Against Urinary Schistosomiasis

Albert Schweitzer Hospital

Status and phase: Completed; Phase 2

Conditions: Urinary Schistosomiasis

Treatments: Drug: Mefloquine; Drug: S/P

Study type: Interventional

Funder types: Other

Identifiers

NCT01132248

IDC-2010-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups, including a placebo group

Mefloquine

Experimental group

Description:

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

Treatment:

Drug: Mefloquine

S/P

Placebo Comparator group

Description:

sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations

Treatment:

Drug: S/P