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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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9 January 2017 |
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Main ID: |
NCT02597556 |
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Date of registration:
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03/11/2015 |
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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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The Impact of Anthelmintic Treatment on the Incidence of Diarrheal Disease in Vietnamese School Children
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Impact of Anthelmintic Treatment on the Incidence of Diarrheal Disease in School Children in Southern Vietnam |
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Date of first enrolment:
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February 2016 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02597556 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Jacqueline Leung, MA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Princeton University, USA |
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Name:
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Stephen Baker, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oxford University Clinical Research Unit |
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Name:
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Nghia Ho Dang Trung, PhD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pham Ngoc Thach University of Medicine |
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Name:
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Andrea Graham, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Princeton University, USA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Between 6-15 years of age
- Written informed consent from a parent or guardian
- Written assent from children >10 years of age
Exclusion Criteria:
- Subjects who do not fulfill any component of the inclusion criteria
- Subjects that are both hookworm-positive and anemic, as defined by the WHO guidelines
Age minimum:
6 Years
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diarrhea
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Intestinal Helminthiasis
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Intervention(s)
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Drug: Albendazole
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Drug: Placebo
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Primary Outcome(s)
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Incidence of diarrheal disease assessed by 12 months of weekly active and passive case surveillance
[Time Frame: 12 months]
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Secondary Outcome(s)
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Prevalence and intensity of enteric viruses and bacteria that cause diarrhea assessed by real-time PCR and the Luminex xTAG Gastrointestinal Pathogen Panel
[Time Frame: Time Frame: Baseline, 3, 6, 9, and 12 months, and during and two weeks after diarrhea cases]
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Changes in fecal microbiota composition by Illumina sequencing
[Time Frame: Baseline, 0.5, 3, 6, 6.5, 9, and 12 months, and during and two weeks after diarrhea cases]
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Prevalence and intensity of soil-transmitted helminth infections by real-time PCR and microscopy
[Time Frame: Baseline, 0.5, 3, 6, 6.5, 9, and 12 months, and during and two weeks after diarrhea cases]
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Antibody isotype response to helminth and diarrheal antigens by ELISA
[Time Frame: Baseline, 6, and 12 months]
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Changes in blood cytokine (Th1, Th2, TH17, and Treg) levels by bead-based immunoassays
[Time Frame: Baseline, 6, and 12 months of study]
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Mean z-scores (height-for-age, weight-for-age, weight-for-height)
[Time Frame: Baseline and 12 months]
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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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