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Trial record 32 of 1411 for:    Peru

A Study of Acequias Contamination & Association of Infectious Diseases in Peru

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03074760
Recruitment Status : Unknown
Verified March 2017 by BioRed LLC.
Recruitment status was:  Recruiting
First Posted : March 9, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
BioRed LLC

Tracking Information
First Submitted Date March 4, 2017
First Posted Date March 9, 2017
Last Update Posted Date March 31, 2017
Actual Study Start Date March 16, 2017
Estimated Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 8, 2017)
Contamination of acequias [ Time Frame: March 20th - April 1st ]
Presence of Fecal Coliforms in the acequias
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03074760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 8, 2017)
Proportion of population with infections [ Time Frame: March 20th - May 1st ]
Proportion of populations with adenovirus, rotavirus and H. pylori infections
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of Acequias Contamination & Association of Infectious Diseases in Peru
Official Title A Study of Acequias Contamination & Association of Infectious Diseases in Peru
Brief Summary A major water supply utilized in the Lambayeque region are acequias. Acequias are irrigation canals that are utilized by the agriculture industry for the cultivation of consumables. Utilization of contaminated water to irrigate consumables can lead to foodborne illnesses. Contamination studies on the acequias in the Lambayeque region have not been performed to date. The purpose of this study is to test contamination of acequias in 9 districts in Lambayeque and determine if a difference in infection rates exists in districts with contaminated acequias vs. districts without contaminated acequias for the following diseases: H. pylori, Adenovirus, Rotavirus.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population There is no study population in phase I as it is focused on the districts and their corresponding acequias. Phase II of this study will include participants 18 years of age or older who consent to participate and are from the following districts: Eten, Pomalca, Pimentel, Patapo, Pucala, Santa Rosa, Reque, Monsefu and Sana.
Condition Water-Related Diseases
Intervention
  • Diagnostic Test: Adenovirus
    Diagnostic test for the presence of the adenovirus in the population groups
  • Diagnostic Test: Rotavirus
    Diagnostic test for the presence of the Rotavirus in the population groups
  • Diagnostic Test: H. pylori
    Diagnostic test for the presence of H. pylori infection in the population groups
Study Groups/Cohorts
  • Contaminated acequias
    Interventions:
    • Diagnostic Test: Adenovirus
    • Diagnostic Test: Rotavirus
    • Diagnostic Test: H. pylori
  • Non-contaminated acequias
    Interventions:
    • Diagnostic Test: Adenovirus
    • Diagnostic Test: Rotavirus
    • Diagnostic Test: H. pylori
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 8, 2017)
450
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2017
Estimated Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Currently reside in one of the following districts: Eten, Pomalca, Pimentel, Patapo, Pucala, Santa Rosa, Reque, Monsefu and Sana
  • 18 years of age or older
  • Consent to participate

Exclusion Criteria:

  • Currently taking antiviral or antimicrobial medication
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Peru
Removed Location Countries  
 
Administrative Information
NCT Number NCT03074760
Other Study ID Numbers CUIRBRG273
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
Plan to Share IPD: Undecided
Responsible Party BioRed LLC
Study Sponsor BioRed LLC
Collaborators Not Provided
Investigators
Principal Investigator: Robert E Goode Campbell University
PRS Account BioRed LLC
Verification Date March 2017