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Wells and Enteric Disease Transmission Trial (WET - Trial)

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ClinicalTrials.gov Identifier: NCT04258059
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
Temple University

Tracking Information
First Submitted Date  ICMJE February 3, 2020
First Posted Date  ICMJE February 6, 2020
Last Update Posted Date February 24, 2020
Actual Study Start Date  ICMJE December 16, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2020)
Incident gastrointestinal illness [ Time Frame: 12 months ]
The investigators will collect data on the presence of gastrointestinal illness symptoms through weekly text messages. Households that report symptoms through text messages will be directed to an online illness questionnaire to characterize the symptoms (incidence, severity, duration, diarrhea, vomiting, coughing, etc.), febrile episodes, as well as relevant exposure information such as recent travel, exposure to ill persons, etc. Incident gastrointestinal illness (GI) is defined by the reporting of a minimum of three episodes of diarrhea or vomiting in a 24 hour period. Each illness will be considered distinct when separated by ≥ 6 symptom-free days.
Original Primary Outcome Measures  ICMJE Same as current
Change History
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 Wells and Enteric Disease Transmission Trial (WET - Trial)
Official Title  ICMJE Wells and Enteric Disease Transmission - A Randomized Controlled Trial (WET- Trial)
Brief Summary Approximately 40 million people in the US are served by private wells, many of which are untreated. The investigators estimate that 1.29 million cases of gastrointestinal illness (GI) per year are attributed to consuming water from untreated private wells in the US. These cases of GI can cause a significant burden in terms of health care costs and lost work/school days, as well as increased risk to developing longer term health complications. This impact is magnified when accounting for vulnerable populations such as children under the age of 5, the elderly and the immunocompromised. The investigators are preparing to conduct the first household randomized controlled trial (RCT) to investigate whether consuming well water treated by ultraviolet light (UV) compared to consuming untreated private well water decreases the incidence of self-reported gastrointestinal illness and respiratory infections in children under 5. The investigators will collect illness symptom data using a combination of weekly text messages and online illness questionnaires.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Gastrointestinal Infection
  • Respiratory Viral Infection
Intervention  ICMJE
  • Device: Active household UV water treatment device
    This point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home.
  • Device: Inactive household UV water treatment device
    This sham device will use a lamp not emitting germicidal UV.
Study Arms  ICMJE
  • Active Comparator: Active UV Device
    A household water treatment device with a lamp emitting germicidal UV. The device will be operated at 50 millijoule per square centimeter to treat >99.9% of all bacteria, protozoa, and most viruses in water supplies.
    Intervention: Device: Active household UV water treatment device
  • Sham Comparator: Inactive UV Device
    A device that appears identical to the active comparator device except the lamp will not emit germicidal UV.
    Intervention: Device: Inactive household UV water treatment device
Publications *

*   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: February 4, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Child resides in Berks, Bucks, Chester, Lancaster, Lehigh, or Montgomery County in Pennsylvania
  • Household is served by a private well
  • Participant child is under the age of 5 (under 4 at time of enrollment), who is a full-time resident of the home and drinks untreated well water (75% or more of water consumption must be from untreated well water)
  • Parent/guardian has access to a phone with texting capabilities

Exclusion Criteria:

  • Child participant is immunocompromised
  • Child participant has a chronic gastrointestinal condition
  • Child takes daily oral steroids
  • Household treats water before consumption (with the exception of water softeners)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Heather Murphy, PhD 215-204-4766 heather.murphy@temple.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04258059
Other Study ID Numbers  ICMJE 25665
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE Pennsylvania Department of Health
Investigators  ICMJE
Principal Investigator: Heather Murphy, PhD Assistant Professor
PRS Account Temple University
Verification Date February 2020

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