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Could a simple blood test ensure the right TB dose for kids?

NCT ID NCT00164450

Disease control Sponsor: Centers for Disease Control and Prevention Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial investigates whether the dose of rifapentine given to children aged 2 to 11 with latent tuberculosis infection is adequate. Researchers measure the drug level in a single blood sample taken 24 hours after a dose and compare it to levels in adults. The goal is to ensure children receive a dose that is both safe and effective for preventing active TB.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rifapentine and isoniazid
What this could lead to
If successful, this could confirm that the chosen doses of rifapentine and isoniazid are effective for treating latent tuberculosis in children aged 2 to 11.
What could go wrong
This is a small pharmacokinetic substudy, not a full efficacy trial. It only checks drug levels, not whether the infection is actually cured. Results may not apply to all children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

158 people

The number who actually took part.

Start date

Sep 2005

Finished

Aug 2008

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. 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. Exclusion Criteria: * None

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Conditions

The condition(s) this trial relates to.

latent tuberculosis infection tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tuberculosis

Contacts and locations

Locations

  • Agencia de Salut Publica

    Barcelona, 080023, Spain

  • Audie L. Murphy VA Hospital

    San Antonio, Texas, 78284, United States

  • Boston University Medical Center

    Boston, Massachusetts, 02118, United States

  • Central Arkansas Veterans Health System

    Little Rock, Arkansas, 72205, United States

  • Columbia University

    New York, New York, 10032, United States

  • Denver Public Health Department

    Denver, Colorado, 80204, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30303, United States

  • Hines Veterans Administration Medical Center

    Hines, Illinois, 60141, United States

  • Hopital Universitario Clementino Fraga Filho

    Rio de Janeiro, 2194.590, Brazil

  • Houston Veterans Administration Medical Center

    Houston, Texas, 77030, United States

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21231, United States

  • Montreal Chest Institute

    Montreal, Quebec, H2X 2P4, Canada

  • New Jersey School of Medicine

    Newark, New Jersey, 07103, United States

  • Northwestern University School of Medicine

    Chicago, Illinois, 21231, United States

  • Seattle-King County Health Department

    Seattle, Washington, 98104, United States

  • University of British Columbia

    Vancouver, British Columbia, V5Z 4R4, Canada

  • University of California at San Diego

    San Diego, California, 92103, United States

  • University of California, San Francisco

    San Francisco, California, 94110, United States

  • University of Manitoba

    Winnepeg, Manitoba, R3A 1R8, Canada

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76104, United States

  • University of Southern California Medical Center

    Los Angeles, California, 90033, United States

  • Veterans Administration Tennessee Valley Health Care System

    Nashville, Tennessee, 37232, United States

  • Washington DC Veterans Administration Medical Center

    Washington D.C., District of Columbia, 20422, United States

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