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

NCT ID: NCT03078894

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-17

Study Completion Date

2017-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tropical Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Zika Dengue Chikagunya Peru

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Districts: Contaminated Water

Subjects in this group are from districts that have contaminated water sources.

Zika

Intervention Type DIAGNOSTIC_TEST

Zika Diagnostic test

Chikagunya

Intervention Type DIAGNOSTIC_TEST

Chikagunya Diagnostic test

Dengue

Intervention Type DIAGNOSTIC_TEST

Dengue Diagnostic test

Districts: Uncontaminated Water

Subjects in this group are from districts that do not have contaminated water sources.

Zika

Intervention Type DIAGNOSTIC_TEST

Zika Diagnostic test

Chikagunya

Intervention Type DIAGNOSTIC_TEST

Chikagunya Diagnostic test

Dengue

Intervention Type DIAGNOSTIC_TEST

Dengue Diagnostic test

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zika

Zika Diagnostic test

Intervention Type DIAGNOSTIC_TEST

Chikagunya

Chikagunya Diagnostic test

Intervention Type DIAGNOSTIC_TEST

Dengue

Dengue Diagnostic test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Not currently taking antiviral or antimicrobial medication
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BioRed LLC

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Trentice Lazard

Role: PRINCIPAL_INVESTIGATOR

Campbell University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

BioRed

Hacienda Pucala, Lambayeque, Peru

Site Status RECRUITING

BioRed

Pátapo, Lambayeque, Peru

Site Status RECRUITING

BioRed

Tumán, Lambayeque, Peru

Site Status RECRUITING

BioRed

Pomalca, , Peru

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Peru

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Trentice Lazard, MBA

Role: CONTACT

Phone: 337-794-9713

Email: [email protected]

Robert E Goode, MBA

Role: CONTACT

Phone: 919-672-2212

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lozado Dominguez

Role: primary

Lozado Dominguez

Role: primary

Lozado Dominguez

Role: primary

Lozado Dominguez

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CUIRBTL231

Identifier Type: -

Identifier Source: org_study_id