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TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection
Sponsor: Centers for Disease Control and Prevention
Summary
Compared to adults, children appear to require higher weight-based doses of rifapentine to acheive comparable drug levels. TBTC Study 26, a study of the effectiveness and tolerability of weekly rifapentine/isoniazid for three months versus daily isoniazid for nine months for the treatment of latent tuberculosis infection, has been amended to include children ages 2-11 based on an initial single-dose study and pharmacokinetic modeling. Study 26PK evaluates the adequacy of the doses chosen for young children enrolled in Study 26 with a single blood draw, 24 hours after the third or subsequent weekly Study 26 dose of rifapentine and isoniazid. An adult control is enrolled for each child enrolled.
Official title: TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children Receiving Once Weekly Rifapentine and Isoniazid for the Treatment of Latent Tuberculosis Infection
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
158
Start Date
2005-09
Completion Date
2008-08
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
Isoniazid
Isoniazid daily, oral, nine months
Rifapentine
Rifapentine plus Isoniazid taken orally, weekly, by direct observation for 12 weeks
Locations (24)
Central Arkansas Veterans Health System
Little Rock, Arkansas, United States
University of Southern California Medical Center
Los Angeles, California, United States
University of California at San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Denver Public Health Department
Denver, Colorado, United States
Washington DC Veterans Administration Medical Center
Washington D.C., District of Columbia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Northwestern University School of Medicine
Chicago, Illinois, United States
Hines Veterans Administration Medical Center
Hines, Illinois, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Boston University Medical Center
Boston, Massachusetts, United States
New Jersey School of Medicine
Newark, New Jersey, United States
Columbia University
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Veterans Administration Tennessee Valley Health Care System
Nashville, Tennessee, United States
University of North Texas Health Science Center
Fort Worth, Texas, United States
Houston Veterans Administration Medical Center
Houston, Texas, United States
Audie L. Murphy VA Hospital
San Antonio, Texas, United States
Seattle-King County Health Department
Seattle, Washington, United States
Hopital Universitario Clementino Fraga Filho
Rio de Janeiro, Brazil
University of British Columbia
Vancouver, British Columbia, Canada
University of Manitoba
Winnepeg, Manitoba, Canada
Montreal Chest Institute
Montreal, Quebec, Canada
Agencia de Salut Publica
Barcelona, Spain