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Monitoring Drug Efficacy and Anthelmintic Resistance in Soil-transmitted Helminth Programs

NCT04177654 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9457

Last updated 2023-08-29

No results posted yet for this study

Summary

Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. To control the morbidity due to these worms, school-based deworming programs are implemented, in which anthelminthic drugs are administered to children without prior diagnosis. The continued fight against these worms is aided by the London declaration on neglected tropical diseases, which helps sustain and expand global drug donation program, resulting in an unprecedented growth of deworming programs. However, the high degree of drug pressure makes deworming programs vulnerable to the development of anthelmintic resistance because they only rely on one drug with sometimes suboptimal efficacy and there is no availability of alternative drugs. Moreover, at present, there is no surveillance system to monitor the emergence and spread of anthelmintic resistance. It remains unclear to what extent the efficacy of drugs may have dropped and whether anthelmintic resistance is already present. This project aims to strengthen the monitoring and surveillance of drug efficacy and anthelmintic resistance in STH programs. As such, it will support deworming programs in their quest to eliminate STHs as a public health problem. The overall aim of this study is to pilot a surveillance system to assess anthelmintic drug efficacy and the emergence of AR in 9 countries were drug pressure has been high over a long period of time.

The specific objectives are to:

1. Assess the prevalence of moderate/heavy intensity infections of the different STH
2. Assess the drug efficacy of a single dose of BZ drugs against STH infections in these countries
3. Assess the frequency of the ß-tubulin SNPs linked to BZ resistance
4. Identify implementation-related barriers and opportunities for monitoring drug efficacy and AR in national PC programs for STH.
5. Expand the Starworms repository of STH field samples

Conditions

  • Soil-transmitted Helminth Infections

Interventions

DRUG

Benzimidazoles

A single dose of benzimidazole drug (400mg Albendazole or 500mg Mebendazole) will be administered as part of routine deworming services.

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Principal Investigators

  • Bruno Levecke, PhD · University Ghent

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • Bangladesh
  • Cambodia
  • Ghana
  • Haiti
  • Laos
  • Rwanda
  • Senegal
  • Vietnam

Study Locations

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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 NCT04177654 on ClinicalTrials.gov