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Can a more powerful antibiotic clear TB faster? a trial puts rifapentine to the test.

NCT ID NCT00694629

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 23, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This trial compares the antibiotic rifapentine against the standard drug rifampin during the first 8 weeks of treatment for pulmonary tuberculosis. About 334 adults with TB bacteria in their sputum are randomly assigned to receive either the standard regimen or one with rifapentine at different doses. The key question is whether rifapentine can turn sputum cultures negative more quickly, which could lead to shorter, more effective treatment.

What this could mean

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

Active substance
the drug rifapentine, an antibiotic related to rifampin
What this could lead to
If rifapentine works better than the standard drug, it could shorten the intensive phase of TB treatment and reduce the risk of drug resistance.
What could go wrong
This is an early Phase 2 trial, so the higher doses may cause more side effects or not improve bacterial clearance. 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

334 people

The number who actually took part.

Start date

Dec 2008

Finished

Dec 2013

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: 1. Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated or induced sputum. 2. Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 3 months prior to enrollment. 3. 5 (five) or fewer days of multidrug therapy for tuberculosis disease in the 6 months preceding initiation of study drugs. 4. 7 (seven) or fewer days of fluoroquinolone therapy in the 30 days preceding initiation of study drugs. 5. Age \>= 18 years 6. Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs; see Appendix B) 7. Signed informed consent 8. Women of child-bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual intercourse during study therapy. 9. Laboratory parameters done within 14 days prior to, enrollment: * Serum or plasma alanine aminotransferase (ALT) activity ≤ 3 times the upper limit of normal * Serum or plasma total bilirubin level ≤ 2.5 times the upper limit of normal * Serum or plasma creatinine level ≤ 2 times the upper limit of normal * Complete blood count with hemoglobin level of at least 7.0 g/dL * Complete blood count with platelet count of at least 100,000/mm3 * Negative pregnancy test (women of childbearing potential) Exclusion Criteria: 1. Pregnant or breast-feeding 2. Known intolerance or allergy to any of the study drugs 3. Concomitant disorders or conditions for which isoniazid (INH), rifamycins, pyrazinamide (PZA), or ethambutol (EMB) are contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gouty arthritis. 4. Current or planned therapy, during the intensive phase of TB therapy, with combination antiretroviral therapy for HIV, or with cyclosporine or tacrolimus. Cyclosporine and tacrolimus have unacceptable interactions with rifamycins. 5. Pulmonary silicosis 6. Central nervous system TB 7. Weight \< 40 kg or \> 85 kg

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Conditions

The condition(s) this trial relates to.

pulmonary tuberculosis

As listed by the trial registrant

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

Pulmonary tuberculosis

Contacts and locations

Locations

  • Agencia de Salut Publica

    Barcelona, 08023, Spain

  • Audi L. Murphy VA Hospital

    San Antonio, Texas, 78284, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Central Arkansas Veterans Health System

    Little Rock, Arkansas, 72205, United States

  • Chicago VA Medical Center (Lakeside)

    Chicago, Illinois, 60611, United States

  • Columbia University/Presbyterian Medical Center

    New York, New York, 10032, United States

  • Denver Department of Public Health and Hospitals

    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

  • Harlem Hospital, Columbia University

    New York, New York, 10037, United States

  • Hines VA 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

  • LA County/USC Medical Center

    Los Angeles, California, 90033, United States

  • Makerere University Medical School

    Kampala, Uganda

  • Montreal Chest Institute McGill University

    Montreal, Quebec, H2X 2P4Pq Canada, Canada

  • Nashville VA Medical Center

    Nashville, Tennessee, 37212-2637, United States

  • Nelson R Mandela School of Medicine

    Durban, KwaZulu-Natal, South Africa

  • New Jersey Medical School

    Newark, New Jersey, 07107-3001, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Seattle King County Health Department

    Seattle, Washington, 98104, United States

  • University of California at San Diego

    San Diego, California, 92103, United States

  • University of California, San Francincisco

    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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