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Personalized TB treatment could shorten recovery time

NCT ID NCT07595042

Cure Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study tests whether tuberculosis (TB) treatment can be tailored to each person's risk of a poor outcome. About 900 adults with drug-sensitive TB will be grouped as lower-risk or higher-risk. Lower-risk participants may get a shorter treatment course, while higher-risk participants may receive a stronger drug combination. The goal is to see if personalized treatment can improve cure rates and reduce side effects.

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

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

13 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: * Has pulmonary tuberculosis (TB) that is likely to respond to standard TB medicines (drug-susceptible TB), based on sputum testing done within 7 days before entering the study. The test must show Mycobacterium tuberculosis is present, with no rifamycin resistance detected and no known resistance to isoniazid or fluoroquinolones. * Has a SPECTRA-TB risk score and risk group assigned during screening using the study-specific calculator. * Has a Karnofsky performance score of 50 or higher within 30 days before entering the study. * Has documented HIV-1 status (either with HIV or without HIV) based on acceptable testing. * If living with HIV, has a CD4+ cell count of at least 50 cells/mm3 within 60 days before study entry. * If living with HIV, is currently receiving or plans to start an efavirenz-based or dolutegravir-based antiretroviral therapy regimen by study week 8. * Has laboratory test results within 7 days before study entry that meet all of the following: * alanine aminotransferase (ALT) no more than 3 times the upper limit of normal * total bilirubin no more than 2.5 times the upper limit of normal * creatinine no more than 2 times the upper limit of normal * potassium between 3.5 and 5.5 mEq/L * absolute neutrophil count at least 1000/mm3 * hemoglobin at least 7.0 g/dL * platelet count at least 100,000/mm3 * If able to become pregnant, has a negative blood or urine pregnancy test within 7 days before study entry. * If able to become pregnant and sexually active in a way that could lead to pregnancy, agrees not to try to become pregnant and agrees to use at least 1 reliable non-hormonal birth control method during study treatment and for 30 days after stopping study drugs. Acceptable methods include: * condoms * intrauterine device (IUD) or intrauterine system (IUS) * cervical cap with spermicide * diaphragm with spermicide * If not able to become pregnant, has a history or documentation of menopause, hysterectomy, bilateral removal of the ovaries, or bilateral tubal ligation. * Has a verifiable address or place of residence and is willing to tell the study team about any change of address during treatment and follow-up. * Is willing and able to give informed consent, or assent with permission from a parent or legal guardian if required. Exclusion Criteria: * TB bacteria are known to be resistant to 1 or more of the following medicines: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones. * Received more than 5 days of treatment for active TB within the 24 weeks before study entry. * Received more than 5 days of treatment within the 30 days before study entry with certain TB medicines or related antibiotics, including isoniazid, rifampin, rifapentine, ethambutol, moxifloxacin, pyrazinamide, aminoglycosides, fluoroquinolones, linezolid, bedaquiline, pretomanid, and other specified anti-TB drugs. * Has suspected or confirmed TB involving the brain or central nervous system, bones, joints, heart lining (pericardium), or miliary TB. * Has a past history of suspected or confirmed drug-resistant TB of any type. * Is currently pregnant or breastfeeding. * Cannot take medicines by mouth. * Has an HIV/AIDS-related opportunistic infection at study entry. * Has acute or chronic hepatitis B, unless the hepatitis B infection has cleared. * Has acute or chronic hepatitis C, unless the hepatitis C infection has cleared or has been successfully treated. * Has alcohol-related liver disease. * Has liver cirrhosis. * Has a history of aortic aneurysm or aortic dissection. * Has a known history of long QT syndrome, a first-degree relative with long QT syndrome, or a screening ECG showing QTcF greater than 470 ms that does not correct with treatment of contributing factors. * Is taking other medicines that can prolong the QT interval and cannot safely switch to an alternative medicine. * Has a known history of acute intermittent porphyria. * Weighs less than 30 kg. * Is currently using, or is expected to need within 24 weeks after enrollment, 1 or more medicines that are not allowed during the study. * Has a known allergy, sensitivity, or hypersensitivity to any of the study drugs or their ingredients. * Has active drug or alcohol use, dependence, mental illness, or another serious infection that, in the opinion of the site investigator, could make it hard to follow the study requirements. * Is currently taking part in another interventional clinical trial.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease pulmonary tuberculosis tuberculosis

As listed by the trial registrant

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

Tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites in 16 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barranco CRS (Site #: 11301)

    Lima, Peru

  • Blantyre CRS (Site #: 30301)

    Blantyre, Malawi

  • Byramjee Jeejeebhoy Government Medical College (BJGMC) CRS (Site #: 31441)

    Pune, Maharashtra, 411001, India

  • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site # 31970)

    Callao, Peru

  • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site #: 31784)

    Chiang Mai, 50200, Thailand

  • Chiangrai Prachanukroh Hospital NICHD CRS (Site # 5116)

    Chiang Rai, Thailand

  • Fundacion Huesped CRS (Site # 31957)

    Buenos Aires, Argentina

  • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (Site #: 31730)

    Port-au-Prince, HT-6110, Haiti

  • Gaborone CRS (Site #: 12701)

    Gaborone, Botswana

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site #: 12101)

    Rio de Janeiro, 21040-360, Brazil

  • Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site # 12201)

    Rio Grande, Brazil

  • Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site (Site #: 12401)

    Kampala, 10005, Uganda

  • Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (Site #: 12501)

    Kericho, Rift Valley, 20200, Kenya

  • Kilimanjaro Christian Medical Centre (KCMC) (Site # 5118)

    Moshi, Tanzania

  • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS (Site #: 30022)

    Port-au-Prince, HT-6110, Haiti

  • MU-JHU Research Collaboration (MUJHU CARE LTD) CRS (Site # 30293)

    Kampala, Uganda

  • Malawi CRS (Site #: 12001)

    Lilongwe, Central Region, Malawi

  • Milton Park CRS (Site #: 30313)

    Harare, 263663, Zimbabwe

  • Moi University Clinical Research Center (MUCRC) CRS (Site #: 12601)

    Eldoret, Rift Valley, 30100, Kenya

  • Molepolole CRS (Site # 12702)

    Gaborone, Botswana

  • National Lung Hospital (Site #: 32483)

    Hanoi, 100000, Vietnam

  • Nutrición-Mexico CRS (Site #: 32078)

    Mexico City, 14000, Mexico

  • San Miguel CRS (Site # 11302)

    Lima, Peru

  • Siriraj Hospital, Mahidol University NICHD CRS (Site # 5115)

    Bangkok, Thailand

  • Socios en Salud Sucursal Peru CRS (Site # 31985)

    Lima, Peru

  • TB HIV Innovations and Clinical Research Foundation Corp. (Site #: 31981)

    Dasmariñas, Cavite, 4114, Philippines

  • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site #: 31802)

    Pathum Wan, Bangkok, 10330, Thailand

  • Vietnam-University of Sydney CRS (Site # 32495)

    Sydney, Australia

  • YRG CARE CRS (Site # 32075)

    Chennai, India

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