Phase 3
N=356,912
Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)
Helminthiasis · Filariasis
Bottom Line
View on ClinicalTrials.gov: NCT03014167 ↗Enrolled (actual)
356,912
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Comparison of Arms - Benin — 322; 748; 11; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Albendazole (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Arms - Benin |
322; 748; 11; 11; 123; 59 | — |
| PRIMARY Comparison of Arms - India |
1906; 4310; 3; 3; 17; 7 | — |
| PRIMARY Comparison of Arms - Malawi |
827; 1989; 6; 15; 12; 15 | — |
| PRIMARY N. Americanus Transmission Interruption - Benin |
11; 6; 9; 14 | — |
| PRIMARY N. Americanus Transmission Interruption - India |
1; 0; 19; 20 | — |
| PRIMARY N. Americanus Transmission Interruption - Malawi |
0; 0; 20; 20 | — |
| SECONDARY N. Americanus Transmission Interruption - Pooled |
12; 6; 48; 54 | — |
| SECONDARY Comparison of Arms - Pooled |
3055; 7047; 20; 29; 152; 81 | — |
| SECONDARY STH Transmission Interruption - Pooled |
9; 5; 51; 55 | — |
| SECONDARY STH Transmission Interruption - Benin |
9; 5; 11; 15 | — |
| SECONDARY STH Transmission Interruption - India |
0; 0; 20; 20 | — |
| SECONDARY STH Transmission Interruption - Malawi |
0; 0; 20; 20 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03014167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.