New hope for Drug-Resistant TB: a 6-Month pill regimen

NCT ID NCT06649721

Disease control Sponsor: Huashan Hospital Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial is testing a 6-month, all-oral combination of four drugs (bedaquiline, delamanid, linezolid, and levofloxacin or clofazimine) to treat rifampin-resistant tuberculosis in Chinese teenagers and adults aged 12 and older. The goal is to see if this shorter regimen is effective and safe. 120 participants will take the pills and be followed for up to 72 weeks.

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 or clofazimine
What this could lead to: If successful, this could offer a shorter, all-oral treatment option for drug-resistant tuberculosis, reducing treatment time and side effects.
What could go wrong: This is a single-arm trial with no comparison group, so results may be less reliable. Side effects from the drugs can be serious, and the regimen may not work for everyone.

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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

About 120 people

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

Started

Nov 2024

Expected to finish

Jun 2027

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

12 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: * Participants are willing to sign informed consent of this trial, those without capacity for civil conduct need their legal guardian to sign * Participants (and their legal guardian if applicable) are willing to cooperate to complete all trial procedures * Male or female, 12 years or older, weight ≥ 30kg * Confirmed pulmonary tuberculosis with resistance to rifampin by phenotypic or genotypic susceptibility testing within 3 months, and must be re-confirmed by sputum culture sampled at trial inclusion * Women with childbearing potential should not be pregnant, confirmed by a volunteered negative pregnancy test, and are willing to use effective contraceptive method from giving consent to 3 months after study treatment * Men with childbearing potential must be willing to use condom or other effective contraceptive methods to avoid their sex partners from being pregnant * Women in breastfeeding period must be willing to discontinue breastfeeding from giving consent to 3 months after study treatment * Participants are willing to take HIV test, and willing to take appropriate antiretroviral therapy if positive Exclusion Criteria: * Previously use of Bedaquiline or Delamanid for at least 28 days * Concomitant hematogenous disseminated tuberculosis, or severe pulmonary tuberculosis in investigator's opinion (including tuberculosis of the digestive system, osteoarticular tuberculosis or tuberculous meningitis) * Currently using any drug that has been prohibited in the protocol * History of allergic action to any of the study drugs * Currently participating in any other clinical trials * Cardiovascular risk at screening: (1) QTcF more than 480 milliseconds (ms); (2) History of clinically significant arrythmia, and at investigator's opinion, participation in this study will increase the risk; (3) Decompensated heart failure; (4) Grade 3 high blood pressure and the goals of treatment have not been reached; (5) Abnormal thyroid function; (6) Abnormal serum Ca, Mg or K level; (7) Other conditions with cardiovascular risks in investigator's opinion. * History of optic neuropathy or peripheral neuropathy, and the investigator considers that the condition may progress or deteriorate by participating in the study, or inappropriate to participate * Hepatic disorders at screening: (1) Active viral hepatitis: HBsAg positive or HBV DNA \>1000 CPs/mL, with elevated AST or ALT or HCV RNA positive; (2) Decompensated cirrhosis * Renal disorders at screening: (1) Unstable or rapidly progressive renal disease; (2) Moderate / severe renal disfunction or end-stage renal disease (eGFR\< 60 mL/min/1.73 m2); (3) Serum creatinine ≥133 μmol/L(1.5 mg/mL) in men, or ≥124 μmol/L (1.4 mg/mL) in women * Other abnormal laboratory test: (1) Hemoglobin \< 8.0g/dL; (2) Platelet \<75,000/mm3; (3) Absolute neutrophil count \<1000/mm3; (4) Aspartate transaminase (AST) or alanine aminotransferase (ALT) \>3×upper limit of normal (ULN); (5) Total bilirubin (TBil) \>2×ULN, or \>1.5×ULN together with abnormal AST or ALT; (6) Albumin \<30g/L * The investigator considers that the participant is not able to complete the study process, or the participation is not safe.

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Conditions

The condition(s) this trial relates to.

drug-resistant tuberculosis multidrug-resistant tuberculosis pulmonary tuberculosis rifampicin-resistant tuberculosis

As listed by the trial registrant

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

Drug-resistant tuberculosis Pulmonary tuberculosis Rifampin-resistant tuberculosis

Contacts and locations

Locations

Anhui Chest Hospital

Hefei, Anhui, China
Beijing Chest Hospital

Beijing, China
Changsha Central Hospital

Changsha, Hunan, China
Harbin Chest Hospital

Harbin, Helongjiang, China
Hebei Chest Hospital

Shijiazhuang, Hebei, China
Henan Chest Hospital

Zhengzhou, Henan, China
Henan Infectious Disease Hospital

Zhengzhou, Henan, China
Huashan Hospital

Shanghai, China
Hulunbuir Infectious Disease Hospital

Hulunbuir, Inner Mongolia, China
Infectious Disease Hospital of Changchun

Changchun, Jilin, China
Infectious Disease Hospital of Heilongjiang Province

Harbin, Heilongjiang, China
Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital)

Jiamusi, Heilongjiang, China
Jiangxi Chest Hospital

Nanchang, Jiangxi, China
Jilin Tuberculosis Hospital

Jilin City, Jilin, China
Linyi People Hospital

Linyi, Shandong, China
Liupanshui Third People's Hospital

Liupanshui, Guizhou, China
Luoyang Center Hospital

Luoyang, Henan, China
Public Health Clinical Center of Chengdu

Chengdu, Sichuan, China
Qingdao Chest Hospital

Qingdao, Shandong, China
Shandong Public Health Clinical Center, Shandong University

Jinan, Shandong, China
Shanxi Medical University Affiliated Chest Hospital

Taiyuan, Shanxi, China
Shenyang Chest Hospital

Shenyang, Liaoning, China
The 8th Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China
The Fifth Hospital of Shijiazhuang

Shijiazhuang, Hebei, China
The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China
The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China
The Fourth People's Hospital of Nanning

Nanning, Guangxi, China
The Second Hospital of Nanjing

Nanjing, Jiangsu, China
Tianjin Haihe Hospital

Tianjin, Tianjin Municipality, China
Weifang No.2 People's Hospital

Weifang, Shandong, China
Wenzhou Central Hospital

Wenzhou, Zhejiang, China
Wuhan Pulmonary Hospital，Wuhan Tuberculosis Prevention and Control Institute

Wuhan, Hubei, China
Xi'an Chest Hospital

Xi'an, Shaanxi, China
Yantai Qishan Hospital

Yantai, Shandong, China

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