A Phase 3 interventional study of Albendazole in Helminthiasis and Filariasis, sponsored by University of Washington. Completed at 3 sites in 3 countries. Open to participants aged 12 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by University of Washington · Phase 3, Interventional, and Treatment
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.
Treatment Inclusion Criteria:
Treatment Exclusion Criteria:
Outcome Sampling Inclusion Criteria:
Outcome Sampling Exclusion Criteria:
Twice-yearly community-wide treatment delivered by drug distributors door to door or via community gatherings, depending upon the format of the prior LF program, for three years. All individuals above the age of 12 months will receive a single dose of albendazole.
Drug: Albendazole
Pre-school (pre-SAC) and school-age children (SAC) 12 months of age and older will receive albendazole delivered in accordance with national Ministry of Health guidelines for three years.
Drug: Albendazole
All eligible individuals will receive a single dose of 400 mg albendazole.
Also known as: Albenza
Comparison of Arms - Benin
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Time frame: 5 years (Three years of drug administration and two years of surveillance)
Comparison of Arms - India
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Time frame: 5 years (Three years of drug administration and two years of surveillance)
Comparison of Arms - Malawi
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Time frame: 5 years (Three years of drug administration and two years of surveillance)
N. Americanus Transmission Interruption - Benin
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
N. Americanus Transmission Interruption - India
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
N. Americanus Transmission Interruption - Malawi
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
N. Americanus Transmission Interruption - Pooled
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
Comparison of Arms - Pooled
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Pooled
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Benin
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - India
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Malawi
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
All participants were approached during a baseline census and offered the opportunity to participant in the study. Consent was taken from an adult household member for the entire household.
| Milestone | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| Started | 177705 | 179207 |
| Completed | 119342 | 116665 |
| Not completed | 58363 | 62542 |
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
| Study clusters | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| Transmission interruption | 12 | 6 |
| Did not achieve transmission interruption | 48 | 54 |
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
| Participants | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| N. americanus (primary) | 3055 (0.36 to 0.48) | 7047 |
| A. duodenale | 20 (0.33 to 1.51) | 29 |
| A. lumbricoides | 152 (0.89 to 2.18) | 81 |
| T. trichiura | 22 (0.76 to 3.12) | 15 |
| Any STH species | 3243 (0.37 to 0.49) | 7153 |
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
| Participants | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| N. americanus — N americanus | 322 | 748 |
| A duodenale — N americanus | 11 | 11 |
| A lumbricoides — N americanus | 123 | 59 |
| T trichiura — N americanus | 13 | 6 |
| Any STH species — N americanus | 467 | 819 |
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
| Participants | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| N. americanus (primary) | 1906 (0.32 to 0.52) | 4310 |
| A. duodenale | 3 (0.17 to 4.94) | 3 |
| A. lumbricoides | 17 (0.81 to 5.29) | 7 |
| T. trichiura | 7 (0.34 to 2.67) | 5 |
| Any STH species | 1930 (0.33 to 0.52) | 4318 (na to na) |
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
| Participants | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| N. americanus (primary) | 827 (0.34 to 0.46) | 1989 (na to na) |
| A. duodenale | 6 (0.07 to 1.40) | 15 (na to na) |
| A. lumbricoides | 12 (0.37 to 1.38) | 15 (na to na) |
| T. trichiura | 2 (0.03 to 2.63) | 4 (na to na) |
| Any STH species | 846 (0.35 to 0.47) | 2016 (na to na) |
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
| Study clusters | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| Transmission interruption | 11 | 6 |
| Did not achieve transmission interruption | 9 | 14 |
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
| Study clusters | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| Transmission interruption | 1 | 0 |
| Did not achieve transmission interruption | 19 | 20 |
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
| Study clusters | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| Transmission interruption | 9 | 5 |
| Did not achieve transmission interruption | 51 | 55 |
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
| Study clusters | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| Transmission interruption | 9 | 5 |
| Did not achieve transmission interruption | 11 | 15 |
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
| Study clusters | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| Transmission interruption | 0 | 0 |
| Did not achieve transmission interruption | 20 | 20 |
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
| Study clusters | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| Transmission interruption | 0 | 0 |
| Did not achieve transmission interruption | 20 | 20 |
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
| Study clusters | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|---|---|
| Transmission interruption | 0 | 0 |
| Did not achieve transmission interruption | 20 | 20 |
Collected over 2 years, 9 months. Treatment with albendazole is known to be safe and billions of doses have been distributed over the previous decades. Therefore, a comparison between arms was not an objective of the study and adverse events were only collected to reduce the risk of harm to research subjects. Therefore, adverse events were passively ascertained during rounds of mass drug administration contacted the study staff and a study clinician reviewed and responded to adverse events.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Community-wide Deworming (Intervention) | 0/242,344 (0%) | 13/242,344 (0%) | 0/242,344 (0%) |
| Event | Community-wide Deworming (Intervention) |
|---|---|
| FaintingGeneral disorders | 4/242344 |
| Fever / malariaInfections and infestations | 4/242344 |
| Acute gastroenteritisGastrointestinal disorders | 3/242344 |
| Viral feverGastrointestinal disorders | 1/242344 |
| Impacted bowelGastrointestinal disorders | 1/242344 |
Censused population prior to the intervention
| Age, Customized(Participants) | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) | Total |
|---|---|---|---|
| Age category — Infants (<1 year) | 4337 | 4396 | 8733 |
| Age category — Pre-school-age children (1-4 years) | 18491 | 18634 | 37125 |
| Age category — School-age children (5-14 years) | 42471 | 43062 | 85533 |
| Age category — Adults (15+ years) | 112284 | 113618 | 225902 |
| Age category — Unknown | 122 | 301 | 423 |
| Sex/Gender, Customized(Participants) | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) | Total |
|---|---|---|---|
| Sex — Male | 86233 | 87430 | 173663 |
| Sex — Female | 91466 | 92564 | 184030 |
| Sex — Other | 6 | 17 | 23 |
| Race/Ethnicity, Customized(Participants) | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) | Total |
|---|---|---|---|
| Language — Majority language | 168000 | 169596 | 337596 |
| Language — Minority Language | 7334 | 8149 | 15483 |
| Language — Unknown | 2371 | 2266 | 4637 |
| Region of Enrollment(participants) | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) | Total |
|---|---|---|---|
| Benin | 48241 | 46728 | 94969 |
| Malawi | 61007 | 60811 | 121818 |
| India | 68457 | 72472 | 141929 |
| Baseline STH prevalence: qPCR(Participants) | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) | Total |
|---|---|---|---|
| N. americanus | 2288 | 2214 | 4502 |
| A. lumbricoides | 141 | 148 | 289 |
| A. duodenale | 23 | 17 | 40 |
| T. trichiura | 23 | 19 | 42 |
| Any STH species | 2444 | 2368 | 4812 |
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