- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03078894
A Pilot Study Examining for the Presence of Fecal Coliforms and Tropical Diseases in Peru
A Pilot Study Examining for the Presence of Fecal Coliforms in Peruvian Water Sources and the Association of Tropical Diseases Within Peru
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Tropical diseases are active in South America and measures need to be taken to control these diseases. Sanitation is a major contributing factor as it serves for an ideal breeding ground for vectors. The EPA regulates water contamination and states that a water source can be recognized as contaminated if it contains anything above zero total coliforms. The severity of the water contamination within Peru can be observed by the presence of thermotolerant coliforms in 48% of all water samples. Studies have also found that on 23% of hands, 16% of utensils, and 4% of meals, E. coli was present. The most frequently contaminated item was kitchen cloths in which 89% had coliforms and 42% with E. coli. In 33% of drinking water, 27% of meals, and 23% kitchen utensils, diarrheagenic E. coli was present.
The purpose behind the research being conducted is to assist Peru concerning various factors in order to facilitate the process of working towards the reduction or complete elimination of tropical disease infections such as Dengue, Zika, and Chikungunya. The reason Peru has been identified as being the focal point for the proposed research lies within the factors that surround Peru. Peru is considered a developing country and with that encompasses consequential issues. These issues can manifest in malnutrition, disease ridden environments, debilitating physical repercussions, and many other linked issues.5 Peru also has a substantial market in which producers partake in sugar cane cultivation. "In Peru, Maple Energy anticipates that in 2013, it will harvest 1.075 million gross tons of sugar cane from its plantation for ethanol production." This is significant considering that sugar cane and molasses production attracts mosquitoes and creates a prime nesting ground for mosquitos considering the product as well as the climate which is required to grow these items. The fact that Dengue is so rampant in Peru presents the great possibility that the masking of other infections with similar symptoms such as Chikungunya and Zika is present. Given that Peru is a developing country makes this fact even more feasible considering the minimal access to quality healthcare in many locations, especially rural communities. The location of Peru gives rise to believe that many patients go undiagnosed or misdiagnosed since Peru borders Brazil, in which currently Zika and Chikungunya are currently epidemics sweeping the country. The lack of mandated hygienic practices allows the circulation of many diseases to fester and plague the Peruvian society.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Trentice Lazard, MBA
- Phone Number: 337-794-9713
- Email: tdlazard0413@email.campbell.edu
Study Contact Backup
- Name: Robert E Goode, MBA
- Phone Number: 919-672-2212
- Email: regoode0630@email.campbell.edu
Study Locations
-
-
-
Pomalca, Peru
- Recruiting
- BioRed
-
Contact:
- Lozado Dominguez
-
-
Lambayeque
-
Patapo, Lambayeque, Peru
- Recruiting
- BioRed
-
Contact:
- Lozado Dominguez
-
Pucala, Lambayeque, Peru
- Recruiting
- BioRed
-
Contact:
- Lozado Dominguez
-
Tuman, Lambayeque, Peru
- Recruiting
- BioRed
-
Contact:
- Lozado Dominguez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- From the Following Districts: Tuman, Pomalca, Patapo, Pimentel
- Over the age of 18
Exclusion Criteria:
- Not currently taking antiviral or antimicrobial medication
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Districts: Contaminated Water
Subjects in this group are from districts that have contaminated water sources.
|
Zika Diagnostic test
Chikagunya Diagnostic test
Dengue Diagnostic test
|
Districts: Uncontaminated Water
Subjects in this group are from districts that do not have contaminated water sources.
|
Zika Diagnostic test
Chikagunya Diagnostic test
Dengue Diagnostic test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of contaminated water bodies
Time Frame: March 20th - April1st
|
This is the number of contaminated water sources with fecal coliform
|
March 20th - April1st
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of population with Zika, Dengue or Chikagunya infections
Time Frame: March 20th - May 1st
|
The proportion of people that are positive for Zika, Dengue or Chikagunya infections
|
March 20th - May 1st
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Trentice Lazard, Campbell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CUIRBTL231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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