- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00138346
Epi Cystic Hydatid Disease Peru
August 26, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
Epidemiology of Human Cystic Hydatid Disease
This is a study developed by researchers from the Universidad Peruana Cayetano Heredia, the Universidad Mayor de San Marcos and other local and foreign institutions.
Researchers are performing this research in human beings and animals, in order to determine the best way to understand and eliminate a parasite called Echinococcus granulosus (tapeworm).
The parasite grows and develops in the dogs´ bowel.
The tapeworm produces eggs which are eliminated among the feces and remain in the environment.
Individuals may accidentally ingest the eggs through contaminated food or drinks and develop a disease called cystic hydatid disease.
This disease mainly affects the human lungs and liver.
The parasite grows in the shape of a water bag and it can jeopardize human life.
It also affects sheep, goats, llamas and alpacas.
The study will enroll almost 840 volunteers who are older than 5 years of age.
It will last about 3 years.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a 3 year study of approximately 840 male and female subjects aged 5 years old and above to be conducted in a Peruvian Highland community in Lima, Peru in order to described the dynamic and associated risk factors to both human infection and Cystic Hydatid Disease (CHD).
The purpose is to determine the prevalence and incidence of both infection and disease in human population, to assess the proportion of seroconversion (positive to negative) through follow-up of the same indiviuals every year and to identify risk factors related to human infection and disease by using baseline questionnaire (e.g.
husbandry practices and education level).
Echinococcal infection is prevalent in regions of the world where dogs are used to care for large herds (Lima, Peru).
This study involves collection of 5 ml of blood every year for 3 years.
In addition, CXR and abdominal US will also be performed.
Signs and symptoms of hydatid disease depend on the organ involved (lungs and liver) and the size of the cyst.
At this time, the best therapeutic approach is surgical intervention preceded by careful radiological evaluation plus adjuvant chemotherapy.
The mortality rate post surgery is 1-4% and for those patients who refuse to have surgery, 60%.
Despite the presence of current methods of control, the parasite prevalence appears to be increasing worldwide therefore this study will obtain data to implement a control program to eradicate this zoonosis.
Study Type
Observational
Enrollment
840
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lima, Peru
- Universidad Peruana Cayetano Heredia
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Lima, Peru, Lima 3
- Universidad Nacional Mayor de San Marcos
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Living in study area (Cooperative Tupac Amaru).
- Older than five-years old
Exclusion Criteria:
1. Pregnant woman (only for chest X-ray procedure).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Study Completion
April 1, 2007
Study Registration Dates
First Submitted
August 26, 2005
First Submitted That Met QC Criteria
August 26, 2005
First Posted (Estimate)
August 30, 2005
Study Record Updates
Last Update Posted (Estimate)
August 27, 2010
Last Update Submitted That Met QC Criteria
August 26, 2010
Last Verified
December 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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