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Could a 6-Month pill combo beat Drug-Resistant TB?

NCT ID NCT07198685

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a 6-month combination of four drugs (bedaquiline, delamanid, linezolid, and levofloxacin) works as well as the standard longer treatment for drug-resistant tuberculosis. Fifty-two adults in Hubei, China will be randomly assigned to either the short or standard regimen. The goal is to see if the shorter treatment is safe and effective enough to replace the current long course.

What this could mean

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

Active substance
a combination of bedaquiline, delamanid, linezolid, and levofloxacin
What this could lead to
If successful, this could offer a shorter, all-oral treatment option for drug-resistant tuberculosis, reducing the burden of long-term therapy.
What could go wrong
This is a small, early-stage study in one Chinese province, so results may not apply broadly. The shorter regimen might be less effective or have unexpected side effects compared to standard treatment.

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

About 52 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 years

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: * Patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions will be included. * Aged between 18 and 65 years old. * Have never used bedaquiline, delamanid, linezolid, or levofloxacin in the past, or have used them for no more than 4 weeks. * Positive results of mycobacterial culture (either smear-positive or smear-negative) within the recent one month, and no effective anti-tuberculosis treatment received within this one-month period; or in the absence of recent sputum culture results, smear-positive sputum and no effective anti-tuberculosis treatment administered. * No history of respiratory failure or cardiac insufficiency, and no clinically significant arrhythmia manifestations on electrocardiogram. * During the treatment and follow - up periods, patients are required to take medications as per the research project requirements, complete treatment monitoring, and promptly report any adverse reactions to the attending physicians. * Voluntarily participate in this study and sign the informed consent form. Exclusion Criteria: * Individuals with a history of optic neuropathy or peripheral neuropathy, whom the researchers believe may experience progression/worsening during the study or are not suitable for participation in this research. * Chronic active hepatitis, with positive results for three items: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and hepatitis B core antibody (anti - HBc), or HBV - DNA \> 1000 CPs/mL, accompanied by elevated ALT/AST. Elevation of ALT or AST is ≥3 times the upper limit of the normal value, or elevation of total bilirubin and direct bilirubin is ≥2 times the upper limit of the normal value (if it is a temporary elevation, patients can be enrolled after recovery from treatment). * Severe renal insufficiency (creatinine clearance rate (CrCl) less than 30 mL/min). * Individuals who have participated in clinical trials of other unlisted new drugs within the past three months. * Known congenital QT interval prolongation, presence of any disease that can prolong the QT interval, or a QTc \> 450 ms. * Pregnant women or women who may be pregnant. * Any cardiac diseases capable of inducing arrhythmia, such as severe hypertension (poorly controlled blood pressure), left ventricular hypertrophy (including hypertrophic cardiomyopathy), or congestive heart failure accompanied by a reduced left ventricular ejection fraction. * A history of known, untreated, and persistent hypothyroidism. Combined with hematogenous disseminated tuberculosis and central nervous system tuberculosis. * A history of allergy or a known allergy to any investigational medicinal product or related substances. * HIV-positive.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

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    Open the record ↗

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