Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)

Helminthiasis Clinical Trial

Official title:

Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03014167
• Other study ID #: STUDY00000180
• Secondary ID: 1R01AI155739-01A
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 4, 2017
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children and school-age children. However mathematical models suggests that current MDA strategies are not sufficient for interrupting disease transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have successfully treated entire populations with albendazole (in combination with ivermectin or diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project will conduct a series of community-based cluster randomized trials in India, Malawi, and Benin to determine if maintaining three years of MDA with albendazole to entire communities following the cessation of LF programs can interrupt STH transmission in focal geographic areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus targeted MDA of children in interrupting the transmission of STH. Nested implementation science research will be used to optimize the intervention, identify contextual factors influencing trial efficacy, and evaluate the feasibility of sustaining and scaling community-wide MDA for STH. These data will provide evidence necessary to inform future guidelines, policies, and operational plans as country partners engage in intensified approaches to eliminate these disabling diseases.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 502363
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months and older

Eligibility

Treatment Inclusion Criteria:

• Ages 12 months and older

Treatment Exclusion Criteria:

• Children under 12 months of age

• Pregnant women in their first trimester

• History of adverse reaction to benzimidazoles

Outcome Sampling Inclusion Criteria:

• Resident of study clusters

• Ages 12 months and older

• Willingness of adult aged 18 years and above (or age as per country specific ethical guidelines) or parent/guardian of child to provide written informed consent

• Provision of written assent to participate from children aged 8 years and above (or age as per country specific ethical guidelines)

Outcome Sampling Exclusion Criteria:

• Less than 12 months of age

• Individuals who do not typically reside in the study cluster

• Nonconsenting or assenting individuals, as applicable

Related Conditions & MeSH terms

• Filariasis
• Helminthiasis

Intervention

Drug:
• Albendazole
All eligible individuals will receive a single dose of 400 mg albendazole.

Locations

Country	Name	City	State
Benin	Institut de Recherche pour le Développement	Comé
India	Christian Medical College	Vellore
Malawi	London School of Hygiene and Tropical Medicine	Mangochi

Sponsors (10)

Lead Sponsor

Collaborator

University of Washington

Bill and Melinda Gates Foundation, Blantyre Institute for Community Ophthalmology (BICO), Christian Medical College, Vellore, India, Imperial College London, Institut de Recherche Clinique du Bénin (IRCB), Institut de Recherche pour le Developpement, London School of Hygiene and Tropical Medicine, National Institute of Allergy and Infectious Diseases (NIAID), Swiss Tropical & Public Health Institute

Countries where clinical trial is conducted

Benin,  India,  Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	STH transmission interruption	Prevalence of STH infection =2% 24 months following the final round of mass drug administration with albendazole	5 years (Three years of drug administration and two years of surveillance)

External Links

•   University of Washington DeWorm3 Website