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Monitoring the Efficacy of Anthelmintics for the Treatment of Soil Transmitted Helminths P2 (ConWorm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01379326
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : December 5, 2014
Sponsor:
Collaborators:
Commonwealth Scientific and Industrial Research Organisation, Australia
World Health Organization
Institut Pasteur, Cambodia
The University of Queensland
Oswaldo Cruz Foundation
University of Nottingham
University of Yaounde 1
Ivo de Carneri, Pemba Island, Tanzania
National Institute of Malariology, Parasitology and Entomology, Vietnam
Jimma University
The Huesped Foundation
Queensland Institute of Medical Research
Institut Pasteur
Information provided by (Responsible Party):
University Ghent

Brief Summary:

Objectives:

The overall objective is to monitor efficacy of mebendazole (MBZ) against Soil-Transmitted Helminths (STH).

The primary objective is:

(1) to monitor the efficacy a single dose 500 mg of mebendazole (MBZ) against Soil-Transmitted Helminths (STH) infections by means of Faecal Egg Count Reduction (FECR) and Cure Rate (CR).

The secondary objectives are:

  1. to assess the occurrence of Necator americanus and Ancylostoma duodenal.
  2. to assess the occurrence of β-tubulin mutations related to resistance before and after drug administration.
  3. to evaluate the role of dogs and pigs as reservoir for zoonotic transmission.

Condition or disease Intervention/treatment Phase
Ascaris Lumbricoides Ascaris Suum Trichuris Trichiura Trichuris Vulpis Ancylostoma Duodenal Ancylostoma Caninum Ancylostoma Ceylanicum Necator Americanus Drug: Mebendazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of a Single-dose Mebendazole Against Soil-transmitted Helminths in School Children
Study Start Date : December 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Mebendazole

Arm Intervention/treatment
Experimental: Mebendazole Drug: Mebendazole
All children providing stool samples will be treated with mebendazole single table of 500mg under supervision (chewing + water).




Primary Outcome Measures :
  1. Reduction of fecal egg counts at 14 days post-intervention. [ Time Frame: At 14 days post-intervention. ]
    Fecal egg counts at intervention and at 14 days follow-up.


Secondary Outcome Measures :
  1. Distribution of hookworms species. [ Time Frame: Samples will be collected at 14 days of follow-up. ]
    Presence of zoonotic Soil-Transmitted Helminths species, mutations linked with anthelminthic resistance.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria:

  • Subjects who are unable to provide a stool sample at follow-up
  • Subjects who are experiencing a severe concurrent medical condition
  • Subjects with diarrhea at first sampling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379326


Locations
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Argentina
Fundacion Huesped
Buenos Aires, Argentina
Australia
Commonwealth Scientific and Industrial Research Organisation
Brisbane, Australia
Queensland Institute for Medical Research, University of Queensland
Herston QLD, Australia
Brazil
Fundação Oswaldo Cruz
Belo Horizonte, Brazil
Cambodia
Institut Pasteur in Cambodia, Clinical Pathology Unit
Phnom Penh, Cambodia
Cameroon
University of Yaoundé I
Yaoundé I, Cameroon
Ethiopia
College of Public Health and Medical Sciences, Jimma University
Jimma, Ethiopia
Tanzania
Ivo de Carneri, Pemba Island
Zanzibar, Tanzania
Vietnam
National Institute for Malariology, Parasitology and Entomology
Hanoi, Vietnam
Sponsors and Collaborators
University Ghent
Commonwealth Scientific and Industrial Research Organisation, Australia
World Health Organization
Institut Pasteur, Cambodia
The University of Queensland
Oswaldo Cruz Foundation
University of Nottingham
University of Yaounde 1
Ivo de Carneri, Pemba Island, Tanzania
National Institute of Malariology, Parasitology and Entomology, Vietnam
Jimma University
The Huesped Foundation
Queensland Institute of Medical Research
Institut Pasteur
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01379326    
Other Study ID Numbers: 2011/374
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Mebendazole
Piperazine
Piperazine citrate
DMP 777
Antinematodal Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors