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Targeted Screening for Taenia Solium Tapeworms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01296958
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : October 24, 2014
Sponsor:
Collaborators:
Universidad Nacional Mayor de San Marcos
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Seth E O'Neal, MD MPH, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE February 15, 2011
First Posted Date  ICMJE February 16, 2011
Last Update Posted Date October 24, 2014
Study Start Date  ICMJE May 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
Porcine seroprevalence [ Time Frame: Every 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
Intestinal tapeworm prevalence [ Time Frame: 16 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Targeted Screening for Taenia Solium Tapeworms
Official Title  ICMJE Targeted Screening for Taenia Solium Tapeworms
Brief Summary The purpose of this study is to determine whether screening and treatment of tapeworm carriers can decrease community transmission of Taenia solium parasitic infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Taenia Solium Taeniasis
Intervention  ICMJE
  • Drug: Niclosamide
    Single oral dose of niclosamide determined by weight (dose: 11 to 34kg receive 1 gram, 35 to 50kg receive 1.5 grams, over 50kg receive 2 grams)
  • Behavioral: Community education campaign
    Education about prevention of Taenia solium infection provided in a single short (20 minute) interaction with the participant. Education was verbal with visual aids.
Study Arms  ICMJE
  • Experimental: Targeted screening
    Screening for intestinal tapeworm carrier followed by treatment with niclosamide as indicated.
    Intervention: Drug: Niclosamide
  • Active Comparator: Education
    Community education about Taenia solium prevention.
    Intervention: Behavioral: Community education campaign
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2014)
1811
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2011)
1600
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All community members are eligible

Exclusion Criteria:

  • Inability to provide informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01296958
Other Study ID Numbers  ICMJE 1R21NS069275-01( U.S. NIH Grant/Contract )
1R21NS069275-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seth E O'Neal, MD MPH, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE
  • Universidad Nacional Mayor de San Marcos
  • National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Seth E ONeal, MD MPH Oregon Health and Science University
Principal Investigator: Armando Gonzalez, DVM PhD San Marcos University School of Veterinary Medicine
PRS Account Oregon Health and Science University
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP