Epi Cystic Hydatid Disease Peru

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00138346
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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 dogsĀ“ 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Time Perspective:
    Prospective
    Official Title:
    Epidemiology of Human Cystic Hydatid Disease
    Study Start Date :
    Aug 1, 2004
    Study Completion Date :
    Apr 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      5 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      1. Living in study area (Cooperative Tupac Amaru).

      2. Older than five-years old

      Exclusion Criteria:
      1. Pregnant woman (only for chest X-ray procedure).

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Universidad Nacional Mayor de San Marcos Lima Peru Lima 3
      2 Universidad Peruana Cayetano Heredia Lima Peru

      Sponsors and Collaborators

      • National Institute of Allergy and Infectious Diseases (NIAID)

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00138346
      Other Study ID Numbers:
      • 04-045
      First Posted:
      Aug 30, 2005
      Last Update Posted:
      Aug 27, 2010
      Last Verified:
      Dec 1, 2006
      Keywords provided by , ,
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Aug 27, 2010