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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00138359
Other study ID # 04-043
Secondary ID
Status Terminated
Phase N/A
First received August 26, 2005
Last updated August 26, 2010
Start date December 2004
Est. completion date January 2005

Study information

Verified date December 2006
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Investigators from Cayetano Heredia University and Johns Hopkins University are doing this study. They want to see how people and pigs get infected with a parasite, called cysticercus (known as "pig triquina"). Cysticercus attacks the meat of pigs and the brains of people. In the intestine, the parasite is known as "solitaria". This study is to see how treatment in both people and pigs works to control the disease.


Description:

This is a prospective intervention study to determine the efficacy and persistence of effect over time of a single, chemotherapy intervention in both the human and porcine population. Four villages will be selected to be treated against T solium adult (in humans) and larval forms (in pigs), and two villages will receive no intervention and will serve as control villages. Pigs in control villages will be followed during 3 months only, and then the human and porcine populations will receive the intervention treatment. The effect of this intervention will be measured by the prevalence of infection in pigs and parasitic burden of infected pigs at month 3, 6, 9, and 12.


Recruitment information / eligibility

Status Terminated
Enrollment 4200
Est. completion date January 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years and older
Eligibility Inclusion Criteria:

- All consenting individuals older than two years living in the study villages (6 endemic communities of the Northern coast of Peru)

Exclusion Criteria:

- Pregnancy (for antiparasitic treatment only).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Niclosamide


Locations

Country Name City State
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,