Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138346
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2005-08-26
Brief Title:
Epi Cystic Hydatid Disease Peru
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Epidemiology of Human Cystic Hydatid Disease
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None