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Monitoring the Efficacy of Anthelmintics for the Treatment of Soil Transmitted Helminths P2

NCT01379326 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2014-12-05

No results posted yet for this study

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.

Conditions

  • Ascaris Lumbricoides
  • Ascaris Suum
  • Trichuris Trichiura
  • Trichuris Vulpis
  • Ancylostoma Duodenal
  • Ancylostoma Caninum
  • Ancylostoma Ceylanicum
  • Necator Americanus

Interventions

DRUG

Mebendazole

All children providing stool samples will be treated with mebendazole single table of 500mg under supervision (chewing + water).

Sponsors & Collaborators

  • Commonwealth Scientific and Industrial Research Organisation, Australia

    collaborator OTHER_GOV

  • World Health Organization

    collaborator OTHER

  • Institut Pasteur, Cambodia

    collaborator OTHER

  • The University of Queensland

    collaborator OTHER

  • Oswaldo Cruz Foundation

    collaborator OTHER

  • University of Nottingham

    collaborator OTHER

  • University of Yaounde 1

    collaborator OTHER

  • Ivo de Carneri, Pemba Island, Tanzania

    collaborator UNKNOWN

  • National Institute of Malariology, Parasitology and Entomology, Vietnam

    collaborator OTHER_GOV

  • Jimma University

    collaborator OTHER

  • Fundación Huésped

    collaborator OTHER

  • Queensland Institute of Medical Research

    collaborator OTHER

  • Institut Pasteur

    collaborator INDUSTRY

  • University Ghent

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Argentina
  • Australia
  • Brazil
  • Cambodia
  • Cameroon
  • Ethiopia
  • Tanzania
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01379326 on ClinicalTrials.gov