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A Pilot Study Examining for the Presence of Fecal Coliforms and Tropical Diseases in Peru

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ClinicalTrials.gov Identifier: NCT03078894
Recruitment Status : Unknown
Verified March 2017 by BioRed LLC.
Recruitment status was:  Recruiting
First Posted : March 14, 2017
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
BioRed LLC

Tracking Information
First Submitted Date March 8, 2017
First Posted Date March 14, 2017
Last Update Posted Date March 31, 2017
Actual Study Start Date March 17, 2017
Estimated Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2017)
The number of contaminated water bodies [ Time Frame: March 20th - April1st ]
This is the number of contaminated water sources with fecal coliform
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 13, 2017)
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
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 Pilot Study Examining for the Presence of Fecal Coliforms and Tropical Diseases in Peru
Official Title A Pilot Study Examining for the Presence of Fecal Coliforms in Peruvian Water Sources and the Association of Tropical Diseases Within Peru
Brief Summary Tropical diseases are continuously on the rise throughout the world as they are spreading and manifesting in various locations globally. The more prominent vector tends to be the mosquito after it bites a previously infected host. The viruses of Zika, Chikungunya, and Dengue are some of the tropical diseases that are affecting large populations and expanding rapidly. Developing countries are at the highest risk because of the lack of preventive methods that are customarily demonstrated in developed countries. Sanitation issues complicate the problem as contaminated wastewater is ideal for mosquitos to lay eggs. In addition, the organic material in the wastewater serve as food for larvae. The purpose of this study is to test bodies of waters in Peru and examine if contaminated water is a contributing factor in the proportion of the population infected with Zika, Chikanguyna or Dengue.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Residents living in Tuman, Pomalca, Patapo and Pimentel that are over the age of 18 will be selected at random to participate in this study.
Condition Tropical Disease
Intervention
  • Diagnostic Test: Zika
    Zika Diagnostic test
  • Diagnostic Test: Chikagunya
    Chikagunya Diagnostic test
  • Diagnostic Test: Dengue
    Dengue Diagnostic test
Study Groups/Cohorts
  • Districts: Contaminated Water
    Subjects in this group are from districts that have contaminated water sources.
    Interventions:
    • Diagnostic Test: Zika
    • Diagnostic Test: Chikagunya
    • Diagnostic Test: Dengue
  • Districts: Uncontaminated Water
    Subjects in this group are from districts that do not have contaminated water sources.
    Interventions:
    • Diagnostic Test: Zika
    • Diagnostic Test: Chikagunya
    • Diagnostic Test: Dengue
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 13, 2017)
100
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:

  • From the Following Districts: Tuman, Pomalca, Patapo, Pimentel
  • Over the age of 18

Exclusion Criteria:

  • Not currently taking antiviral or antimicrobial medication
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Peru
Removed Location Countries  
 
Administrative Information
NCT Number NCT03078894
Other Study ID Numbers CUIRBTL231
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: Trentice Lazard Campbell University
PRS Account BioRed LLC
Verification Date March 2017