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TB drug dosing under the microscope: could this lead to shorter, safer treatment?

NCT ID NCT02563327

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This completed Phase 3 study measured how high doses of the tuberculosis drugs rifapentine and moxifloxacin move through the body in 53 adults with TB. Participants gave multiple blood samples to track drug levels. The goal was to understand the best doses to kill TB bacteria while avoiding side effects. This research may help refine future TB treatment regimens.

What this could mean

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

Active substance
Rifapentine, Moxifloxacin, Rifampin, Isoniazid, Pyrazinamide, Ethambutol, Pyridoxine
What this could lead to
If successful, this study could help doctors choose the best doses of these TB drugs to cure patients faster and with fewer side effects.
What could go wrong
This is a small, intensive sampling study (53 participants) that looks at drug levels in the body, not a direct test of a new cure. Results may not apply to all TB patients.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,516 people

The number who actually took part.

Started

Jan 2016

Finished

Aug 2021

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

18 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: * Age 18 years or greater * Enrolled in TBTC Study 31 * Randomized to receive one of the rifapentine treatment regimens. * Willingness to be sampled 6 times during 1 PK sampling session and 2 - 3 times during another PK sampling session at an outpatient clinic, a clinical research center, or a hospital. * Written informed consent given for the Study 31 PK/PD study Exclusion Criteria: * Hematocrit \< 25% most recent value, measured within 30 days before PK/PD study enrollment

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Conditions

The condition(s) this trial relates to.

pulmonary tuberculosis tuberculosis

As listed by the trial registrant

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

Tuberculosis

Contacts and locations

Locations

  • Joint Clinical Research Centre/ Makerere Univ Med Sch

    Kampala, Uganda

  • National TB Program

    Hanoi, Vietnam

  • University of Texas Health Science Center at

    San Antonio, Texas, 78229, United States

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