- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00138359
Mass Treatment T Solium Community Study
August 26, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
The Effect of a Single Control Intervention in the T Solium Life Cycle
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment
4200
Phase
- Not Applicable
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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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
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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
December 1, 2004
Study Completion
January 1, 2005
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
- 04-043
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.