Activity of Mefloquine Against Urinary Schistosomiasis

January 23, 2013 updated by: Michael Ramharter, Albert Schweitzer Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Gabon
      • Lambarene, Gabon
        • Albert Schweitzer Hospital
    • Moyen Ogooue
      • Lambaréné, Moyen Ogooue, Gabon, BP 115
        • Albert Schweitzer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Placebo Comparator: S/P
sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations
Drug: S/P
sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks after second IPTp

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rate
Time Frame: 6 weeks after first and second IPTp
Mefloquine may lead to an adequate cure rates of Schistosoma haematobium infections compared to S/P (>80%)
6 weeks after first and second IPTp

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Schweitzer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Estimate)

January 24, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDC-2010-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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