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

NCT01379326 | Completed Phase 4

• 1 other identifier: 2011/374
• Study Type: interventional
• Target: 250
• Locations: 7 countries
• Sites: 8

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. 1.to assess the occurrence of Necator americanus and Ancylostoma duodenal.
2. 2.to assess the occurrence of β-tubulin mutations related to resistance before and after drug administration.
3. 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

Outcome Measures

Primary Outcomes (1)

• Reduction of fecal egg counts at 14 days post-intervention.

  Fecal egg counts at intervention and at 14 days follow-up.

  At 14 days post-intervention.

Secondary Outcomes (1)

• Distribution of hookworms species.

  Samples will be collected at 14 days of follow-up.

Study Arms (1)

Mebendazole

EXPERIMENTAL

Drug: Mebendazole

Interventions

Mebendazole DRUG

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

Mebendazole

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• Commonwealth Scientific and Industrial Research Organisation, Australia: collaborator
• World Health Organization: collaborator
• Institut Pasteur, Cambodia: collaborator
• The University of Queensland: collaborator
• Oswaldo Cruz Foundation: collaborator
• University of Nottingham: collaborator
• University of Yaounde 1: collaborator
• Ivo de Carneri, Pemba Island, Tanzania: collaborator
• National Institute of Malariology, Parasitology and Entomology, Vietnam: collaborator
• Jimma University: collaborator
• Fundación Huésped: collaborator
• Queensland Institute of Medical Research: collaborator
• Institut Pasteur: collaborator

Study Sites (9)

Fundacion Huesped

Buenos Aires, Argentina

Location

Commonwealth Scientific and Industrial Research Organisation

Brisbane, Australia

Location

Queensland Institute for Medical Research, University of Queensland

Herston QLD, Australia

Location

Fundação Oswaldo Cruz

Belo Horizonte, Brazil

Location

Institut Pasteur in Cambodia, Clinical Pathology Unit

Phnom Penh, Cambodia

Location

University of Yaoundé I

Yaoundé I, Cameroon

Location

College of Public Health and Medical Sciences, Jimma University

Jimma, Ethiopia

Location

Ivo de Carneri, Pemba Island

Zanzibar, Tanzania

Location

National Institute for Malariology, Parasitology and Entomology

Hanoi, Vietnam

Location

Related Publications (1)

• Levecke B, Montresor A, Albonico M, Ame SM, Behnke JM, Bethony JM, Noumedem CD, Engels D, Guillard B, Kotze AC, Krolewiecki AJ, McCarthy JS, Mekonnen Z, Periago MV, Sopheak H, Tchuem-Tchuente LA, Duong TT, Huong NT, Zeynudin A, Vercruysse J. Assessment of anthelmintic efficacy of mebendazole in school children in six countries where soil-transmitted helminths are endemic. PLoS Negl Trop Dis. 2014 Oct 9;8(10):e3204. doi: 10.1371/journal.pntd.0003204. eCollection 2014 Oct.

  PMID: 25299391 DERIVED

MeSH Terms

Conditions

Trichuriasis

Interventions

Mebendazole

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 23, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

ET (1); VN (1); CA (1); BR (1); TA (1); AU (2); AR (1)