Epi Cystic Hydatid Disease Peru

E. Granulosus Cystic Hydatid d Clinical Trial

Official title:

Epidemiology of Human Cystic Hydatid Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138346
• Other study ID #: 04-045
• Status: Completed
• Phase: N/A
• First received: August 26, 2005
• Last updated: August 26, 2010
• Start date: August 2004
• Est. completion date: April 2007

Study information

• Verified date: December 2006
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years and older

Eligibility

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).

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• E. Granulosus Cystic Hydatid d

Locations

Country	Name	City	State
Peru	Universidad Nacional Mayor de San Marcos	Lima
Peru	Universidad Peruana Cayetano Heredia	Lima

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Peru,