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NCT00164450 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Centers for Disease Control and Prevention.

Completed
Registry status
NA
Development phase
158
Enrollment target

NCT00164450 is a NA study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 158 participants.

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The verdict

NCT00164450, a NA study, has completed, sponsored by Centers for Disease Control and Prevention.

COMPLETED
Registry status
NA
Development phase
158 participants
Enrollment target

Study 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.

Interventions

  • DRUG Isoniazid
  • DRUG Rifapentine

Trial Details

FieldValue
Enrollment Target 158 participants
Start Date 2005-09
Est. Completion 2008-08
Phase NA

What the Registry Record Tells You About NCT00164450

The ClinicalTrials.gov registry entry for NCT00164450 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centers for Disease Control and Prevention, which has 139 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Isoniazid is the first listed.

NCT00164450 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00164450 about?

NCT00164450 is a clinical study titled "TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection". 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 ...

What is the current status of trial NCT00164450?

This trial is currently completed. It is a NA study. The enrollment target is 158 participants. The study started on 2005-09. Estimated completion is 2008-08.

What interventions are being tested in trial NCT00164450?

The interventions under investigation include: Isoniazid (DRUG), Rifapentine (DRUG).

Who is sponsoring clinical trial NCT00164450?

This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.