Activity of Mefloquine Against Urinary Schistosomiasis

Urinary Schistosomiasis Clinical Trial

Official title:

Activity of Mefloquine Against Urinary Schistosomiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132248
• Other study ID #: IDC-2010-1
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2010
• Last updated: January 23, 2013
• Start date: May 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Albert Schweitzer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Gabon: Ministry of Science and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schistosomiasis
• Schistosomiasis haematobia
• Urinary Schistosomiasis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Gabon	Albert Schweitzer Hospital	Lambarene
Gabon	Albert Schweitzer Hospital	Lambaréné	Moyen Ogooue

Sponsors (1)

Lead Sponsor	Collaborator
Albert Schweitzer Hospital

Country where clinical trial is conducted

Gabon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No