ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03014167
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
University of Washington
Imperial College London
London School of Hygiene and Tropical Medicine
Institut de Recherche Clinique du Bénin (IRCB)
Institut de Recherche pour le Developpement
Christian Medical College, Vellore, India
Blantyre Institute for Community Ophthalmology (BICO)
Swiss Tropical & Public Health Institute
Information provided by (Responsible Party):
Natural History Museum, United Kingdom

Brief 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.

Condition or disease Intervention/treatment Phase
Helminthiasis Filariasis Drug: Albendazole Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)
Actual Study Start Date : October 4, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole

Arm Intervention/treatment
Experimental: Community-wide deworming
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
All eligible individuals will receive a single dose of 400 mg albendazole.
Other Name: Albenza

Active Comparator: Targeted deworming
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.
Other Name: Albenza




Primary Outcome Measures :
  1. STH transmission interruption [ Time Frame: 5 years (Three years of drug administration and two years of surveillance) ]
    Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014167


Contacts
Contact: Judd L Walson, MD, MPH 206-744-3695 ext 43695 walson@uw.edu

Locations
Benin
Institut de Recherche pour le Développement Recruiting
Comé, Benin
Contact: Adrian Luty, PhD, DR       adrian.luty@ird.fr   
India
Christian Medical College Recruiting
Vellore, India
Contact: Gagandeep Kang, MBBS, MD, PhD       gkang@cmcvellore.ac.in   
Malawi
London School of Hygiene and Tropical Medicine Recruiting
Mangochi, Malawi
Contact: Robin Bailey, MA, BM, MRCP, DTM&H, PhD, FRCP       robin.bailey@lshtm.ac.uk   
Sponsors and Collaborators
Natural History Museum, United Kingdom
Bill and Melinda Gates Foundation
University of Washington
Imperial College London
London School of Hygiene and Tropical Medicine
Institut de Recherche Clinique du Bénin (IRCB)
Institut de Recherche pour le Developpement
Christian Medical College, Vellore, India
Blantyre Institute for Community Ophthalmology (BICO)
Swiss Tropical & Public Health Institute
Investigators
Principal Investigator: Judd L Walson, MD, MPH University of Washington Department of Global Health

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Natural History Museum, United Kingdom
ClinicalTrials.gov Identifier: NCT03014167     History of Changes
Other Study ID Numbers: DeWorm3 Project
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Natural History Museum, United Kingdom:
transmission interruption
intestinal nematodes
soil-transmitted helminths
mass drug administration
Benin
India
Malawi

Additional relevant MeSH terms:
Filariasis
Helminthiasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents