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Mass Treatment T Solium Community Study

Primary Purpose

Intestinal Parasitism

Status
Terminated
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Niclosamide
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Parasitism focused on measuring T solium, cysticercus, pig triquina, solitaria, intestinal parasites, Niclosamide, tapeworms, Taeniasis

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Universidad Peruana Cayetano Heredia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 26, 2005
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00138359
Brief Title
Mass Treatment T Solium Community Study
Official Title
The Effect of a Single Control Intervention in the T Solium Life Cycle
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Terminated
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Parasitism
Keywords
T solium, cysticercus, pig triquina, solitaria, intestinal parasites, Niclosamide, tapeworms, Taeniasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Niclosamide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Universidad Peruana Cayetano Heredia
City
Lima
Country
Peru

12. IPD Sharing Statement

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Mass Treatment T Solium Community Study

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