Clinical trial NCT01132248: Activity of Mefloquine Against Urinary Schistosomiasis
Official title: Activity of Mefloquine Against Urinary Schistosomiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Schistosomiasis
Keywords: schistosomiasis, schistosoma haematobium
Lead sponsor: Albert Schweitzer Hospital
Sponsor class: OTHER
First posted: 2010-05-28
Enrollment: 65
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of egg excretion
timeFrame: 6 weeks after second IPTp
Secondary outcomes:
measure: Cure rate
timeFrame: 6 weeks after first and second IPTp
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Albert Schweitzer Hospital
state: Moyen Ogooue
city: Lambarene
country: Gabon
facility: Albert Schweitzer Hospital
Study officials:
References:
citation: 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.
citation: 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.