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Trial record 26 of 50 for:    "Elephantiasis" | "Anti-Infective Agents"

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

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ClinicalTrials.gov Identifier: NCT03014167
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : August 21, 2019
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

Tracking Information
First Submitted Date  ICMJE December 30, 2016
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE October 4, 2017
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03014167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)
Official Title  ICMJE Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Mass drug administration intervention is not blinded to study participants but investigators and outcome assessors remain blind to link between allocation and outcome data
Primary Purpose: Treatment
Condition  ICMJE
  • Helminthiasis
  • Filariasis
Intervention  ICMJE Drug: Albendazole
All eligible individuals will receive a single dose of 400 mg albendazole.
Other Name: Albenza
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Albendazole
  • 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.
    Intervention: Drug: Albendazole
Publications * Ásbjörnsdóttir KH, Ajjampur SSR, Anderson RM, Bailey R, Gardiner I, Halliday KE, Ibikounle M, Kalua K, Kang G, Littlewood DTJ, Luty AJF, Means AR, Oswald W, Pullan RL, Sarkar R, Schär F, Szpiro A, Truscott JE, Werkman M, Yard E, Walson JL; DeWorm3 Trials Team. Assessing the feasibility of interrupting the transmission of soil-transmitted helminths through mass drug administration: The DeWorm3 cluster randomized trial protocol. PLoS Negl Trop Dis. 2018 Jan 18;12(1):e0006166. doi: 10.1371/journal.pntd.0006166. eCollection 2018 Jan. Erratum in: PLoS Negl Trop Dis. 2018 Jan 31;12 (1):e0006253.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2019)
380000
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2017)
240000
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Judd L Walson, MD, MPH 206-744-3695 ext 43695 walson@uw.edu
Listed Location Countries  ICMJE Benin,   India,   Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03014167
Other Study ID Numbers  ICMJE DeWorm3 Project
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Natural History Museum, United Kingdom
Study Sponsor  ICMJE Natural History Museum, United Kingdom
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Judd L Walson, MD, MPH University of Washington Department of Global Health
PRS Account Natural History Museum, United Kingdom
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP