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Trial record 14 of 1405 for:    Peru

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

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.

Condition or disease Intervention/treatment
Tropical Disease Diagnostic Test: Zika Diagnostic Test: Chikagunya Diagnostic Test: 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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Pilot Study Examining for the Presence of Fecal Coliforms in Peruvian Water Sources and the Association of Tropical Diseases Within Peru
Actual Study Start Date : March 17, 2017
Estimated Primary Completion Date : May 1, 2017
Estimated Study Completion Date : May 1, 2017


Group/Cohort Intervention/treatment
Districts: Contaminated Water
Subjects in this group are from districts that have contaminated water sources.
Diagnostic Test: Zika
Zika Diagnostic test

Diagnostic Test: Chikagunya
Chikagunya Diagnostic test

Diagnostic Test: Dengue
Dengue Diagnostic test

Districts: Uncontaminated Water
Subjects in this group are from districts that do not have contaminated water sources.
Diagnostic Test: Zika
Zika Diagnostic test

Diagnostic Test: Chikagunya
Chikagunya Diagnostic test

Diagnostic Test: Dengue
Dengue Diagnostic test




Primary Outcome Measures :
  1. The number of contaminated water bodies [ Time Frame: March 20th - April1st ]
    This is the number of contaminated water sources with fecal coliform


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078894


Contacts
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Contact: Trentice Lazard, MBA 337-794-9713 tdlazard0413@email.campbell.edu
Contact: Robert E Goode, MBA 919-672-2212 regoode0630@email.campbell.edu

Locations
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Peru
BioRed Recruiting
Patapo, Lambayeque, Peru
Contact: Lozado Dominguez         
BioRed Recruiting
Pucala, Lambayeque, Peru
Contact: Lozado Dominguez         
BioRed Recruiting
Tuman, Lambayeque, Peru
Contact: Lozado Dominguez         
BioRed Recruiting
Pomalca, Peru
Contact: Lozado Dominguez         
Sponsors and Collaborators
BioRed LLC
Investigators
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Principal Investigator: Trentice Lazard Campbell University

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Responsible Party: BioRed LLC
ClinicalTrials.gov Identifier: NCT03078894     History of Changes
Other Study ID Numbers: CUIRBTL231
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioRed LLC:
Zika
Dengue
Chikagunya
Peru