NCT03074760

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

March 16, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

March 4, 2017

Last Update Submit

March 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Contamination of acequias

    Presence of Fecal Coliforms in the acequias

    March 20th - April 1st

Secondary Outcomes (1)

  • Proportion of population with infections

    March 20th - May 1st

Study Arms (2)

Contaminated acequias

Diagnostic Test: AdenovirusDiagnostic Test: RotavirusDiagnostic Test: H. pylori

Non-contaminated acequias

Diagnostic Test: AdenovirusDiagnostic Test: RotavirusDiagnostic Test: H. pylori

Interventions

AdenovirusDIAGNOSTIC_TEST

Diagnostic test for the presence of the adenovirus in the population groups

Contaminated acequiasNon-contaminated acequias
RotavirusDIAGNOSTIC_TEST

Diagnostic test for the presence of the Rotavirus in the population groups

Contaminated acequiasNon-contaminated acequias
H. pyloriDIAGNOSTIC_TEST

Diagnostic test for the presence of H. pylori infection in the population groups

Contaminated acequiasNon-contaminated acequias

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Currently taking antiviral or antimicrobial medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

BioRed

Hacienda Pucala, Lambayeque, Peru

RECRUITING

BioRed

Pátapo, Lambayeque, Peru

RECRUITING

BioRed

Pimentel, Lambayeque, Peru

RECRUITING

BioRed

Pomalca, Lambayeque, Peru

RECRUITING

BioRed

Tumán, Lambayeque, Peru

RECRUITING

MeSH Terms

Conditions

Waterborne Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Robert E Goode

    Campbell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2017

First Posted

March 9, 2017

Study Start

March 16, 2017

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations