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.
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
- Recruiting
BioRed
Hacienda Pucala, Lambayeque
Lozado Dominguez
- Recruiting
BioRed
Pátapo, Lambayeque
Lozado Dominguez
- Recruiting
BioRed
Pomalca
Lozado Dominguez
- Recruiting
BioRed
Tumán, Lambayeque
Lozado Dominguez
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.
- Conditions
- Tropical Disease
- 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 group | Role | What they receive |
|---|---|---|
| Districts: Contaminated Water | Subjects in this group are from districts that have contaminated water sources. Receives: 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. 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.
The number of contaminated water bodies
This is the number of contaminated water sources with fecal coliform
Measured: March 20th - April1st
Secondary outcomes (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.
- First posted14 Mar 2017
- Study start17 Mar 2017
- Primary completion1 May 2017 (estimated)
- Study completion1 May 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tropical DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- BioRed LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trentice Lazard, Principal investigator, Campbell University
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining for the Presence of Fecal Coliforms in Peruvian Water Sources and the Association of Tropical Diseases Within Peru
- ClinicalTrials.gov ID
- NCT03078894
- Acronym / sponsor ID
- CUIRBTL231
- Conditions
- Tropical Disease
- Keywords
- Zika, Dengue, Chikagunya, Peru
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BioRed LLCUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 1 May 2017 (estimated)
- Study completion
- 1 May 2017 (estimated)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Districts: Contaminated Water | – | Diagnostic Test: Zika, Diagnostic Test: Chikagunya, Diagnostic Test: DengueSubjects in this group are from districts that have contaminated water sources. |
| Districts: Uncontaminated Water | – | Diagnostic Test: Zika, Diagnostic Test: Chikagunya, Diagnostic Test: DengueSubjects in this group are from districts that do not have contaminated water sources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (2 listed)
- From the Following Districts: Tuman, Pomalca, Patapo, Pimentel
- Over the age of 18
Key exclusion criteria (1 listed)
- Not currently taking antiviral or antimicrobial medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZikaZika Diagnostic test | Diagnostic test | Districts: Contaminated Water, Districts: Uncontaminated Water |
| ChikagunyaChikagunya Diagnostic test | Diagnostic test | Districts: Contaminated Water, Districts: Uncontaminated Water |
| DengueDengue Diagnostic test | Diagnostic test | Districts: Contaminated Water, Districts: Uncontaminated Water |
Primary outcome
The number of contaminated water bodies
Time frame: March 20th - April1st
This is the number of contaminated water sources with fecal coliform
1 secondary outcome
Proportion of population with Zika, Dengue or Chikagunya infections
Time frame: March 20th - May 1st
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trentice Lazard principal investigator
Campbell University
4 sites in 1 country: see every site and its status.
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.