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Activity of Mefloquine Against Urinary Schistosomiasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Ramharter, Albert Schweitzer Hospital
ClinicalTrials.gov Identifier:
NCT01132248
First received: May 27, 2010
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose
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.

Condition Intervention Phase
Urinary Schistosomiasis
 Drug: Mefloquine
Drug: S/P
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Activity of Mefloquine Against Urinary Schistosomiasis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Albert Schweitzer Hospital:

Primary Outcome Measures:
  • Reduction of egg excretion [ Time Frame: 6 weeks after second IPTp ] [ Designated as safety issue: No ]
    Mefloquine reduces egg excretion of Schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (S/P) treatment when given as IPTp


Secondary Outcome Measures:
  • Cure rate [ Time Frame: 6 weeks after first and second IPTp ] [ Designated as safety issue: No ]
    Mefloquine may lead to an adequate cure rates of Schistosoma haematobium infections compared to S/P (>80%)
Enrollment: 65
Study Start Date: May 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132248

Locations
Gabon
Albert Schweitzer Hospital
Lambaréné, Moyen Ogooue, Gabon, BP 115
Albert Schweitzer Hospital
Lambarene, Gabon
Sponsors and Collaborators
Albert Schweitzer Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Ramharter, Ass. Prof. PD, Albert Schweitzer Hospital
ClinicalTrials.gov Identifier: NCT01132248     History of Changes
Other Study ID Numbers: IDC-2010-1 
Study First Received: May 27, 2010
Last Updated: January 23, 2013
Health Authority: Gabon: Ministry of Science and Research

Keywords provided by Albert Schweitzer Hospital:
schistosomiasis, schistosoma haematobium

Additional relevant MeSH terms:
Schistosomiasis
Schistosomiasis haematobia
Trematode Infections
Helminthiasis
Parasitic Diseases
Urinary Tract Infections
Infection
 Urologic Diseases
Mefloquine
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 26, 2016