TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection

Completed · Not applicable

Conditions studied: Tuberculosis

In brief

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.

Key facts

Study ID

NCT00164450

Run by

Centers for Disease Control and Prevention

People needed

158

Starts

2005-09-01

Expected to finish

2008-08-01

Last updated by the study team

2026-07-07

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrolled in TBTC Study 26 randomized to treatment with once weekly isoniazid and rifapentine:
• Child between the ages of 2 to less than 12 years for whom informed consent by a guardian and of assent (if applicable) have been obtained.
• Adult greater than age 18 for whom informed consent has been obtained.
• Willingness to undergo a blood phlebotomy 24 hours following dosing of isoniazid and rifapentine after receiving at least three once-weekly doses of rifapentine plus isoniazid.
• If as a result of a contact investigation, both a parent and child are enrolled in Study 26, both may be co-enrolled into the pharmacokinetic substudy with the adult serving as the control for the child. Preference will be given to a biologic parent of the same gender. If no eligible biologic parent is available for study, the next adult of the same gender and at the same TBTC site, who is substudy eligible, will serve as the adult control.

You may not qualify if…

• None

Where it is running

• 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

Full record on ClinicalTrials.gov

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