Activity of Mefloquine Against Urinary Schistosomiasis - Full Text View

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 Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Activity of Mefloquine Against Urinary Schistosomiasis

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Schistosomiasis Helminthiasis

U.S. FDA Resources

Further study details as provided by Michael Ramharter, Albert Schweitzer Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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%)


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
Sexes 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):

Basra A, Mombo-Ngoma G, Melser MC, Diop DA, Würbel H, Mackanga JR, Fürstenau 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.


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

Keywords provided by Michael Ramharter, Albert Schweitzer Hospital:


schistosomiasis, schistosoma haematobium

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 19, 2017