AzTrials
AzTrials

Tropical DiseaseNCT03078894

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

An observational study of Tropical Disease, run by BioRed LLC at 4 sites in Peru.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tropical Disease
What is being tested?
Zika, Chikagunya and Dengue
How many people
100 participants
Where
4 sitesPeru
Study dates
17 Mar 2017to 1 May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Not currently taking antiviral or antimicrobial medication

Trial locations and contacts

4 sites in 1 country.

Peru4 sites, 4 recruiting
  • BioRed

    Hacienda Pucala, Lambayeque

    Lozado Dominguez

    Recruiting
  • BioRed

    Pátapo, Lambayeque

    Lozado Dominguez

    Recruiting
  • BioRed

    Pomalca

    Lozado Dominguez

    Recruiting
  • BioRed

    Tumán, Lambayeque

    Lozado Dominguez

    Recruiting

Other trials in Peru

About this study

Official title: A Pilot Study Examining for the Presence of Fecal Coliforms in Peruvian Water Sources and the Association of Tropical Diseases Within Peru

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.

Read the 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.

Being tested
Zika, Chikagunya, Dengue
Keywords
Zika, Dengue, Chikagunya, Peru
Medical subject headings
Zika Virus Infection, Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZikaDiagnostic test

    Zika Diagnostic test

  • ChikagunyaDiagnostic test

    Chikagunya Diagnostic test

  • DengueDiagnostic test

    Dengue Diagnostic test

Study groups in NCT03078894
Study groupRoleWhat they receive
Districts: Contaminated WaterSubjects in this group are from districts that have contaminated water sources.
Receives: Diagnostic Test: Zika; Diagnostic Test: Chikagunya; Diagnostic Test: Dengue
Districts: Uncontaminated WaterSubjects in this group are from districts that do not have contaminated water sources.
Receives: Diagnostic Test: Zika; Diagnostic Test: Chikagunya; Diagnostic Test: Dengue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of contaminated water bodies

    This is the number of contaminated water sources with fecal coliform

    Measured: March 20th - April1st

Secondary outcomes (1)
  1. Proportion of population with Zika, Dengue or Chikagunya infections

    The proportion of people that are positive for Zika, Dengue or Chikagunya infections

    Measured: March 20th - May 1st

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2017
  2. Study start17 Mar 2017
  3. Primary completion1 May 2017 (estimated)
  4. Study completion1 May 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03078894
Sponsor's protocol ID
CUIRBTL231
Status last verified
Mar 2017
First submitted
8 Mar 2017
Last updated
31 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Tropical Disease, run by BioRed LLC at 4 sites in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Trentice Lazard, MBA (337-794-9713, tdlazard0413@email.campbell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of contaminated water bodies (time frame: March 20th - April1st). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in