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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2024 |
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Main ID: |
NCT03014167 |
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Date of registration:
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30/12/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)
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Scientific title:
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Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project |
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Date of first enrolment:
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October 4, 2017 |
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Target sample size:
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502363 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03014167 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Benin
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India
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Malawi
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Contacts
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Name:
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Judd L Walson, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington, Departments of Global Health, Medicine (Infectious Disease), Pediatrics and Epidemiology |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Months
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Filariasis
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Helminthiasis
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Intervention(s)
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Drug: Albendazole
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Primary Outcome(s)
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STH transmission interruption
[Time Frame: 5 years (Three years of drug administration and two years of surveillance)]
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Secondary ID(s)
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STUDY00000180
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1R01AI155739-01A1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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