Oral treatment for multidrug-resistant tuberculosis in China
A Pragmatic Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Patients With Multidrug-resistant Tuberculosis in China
This study tests if a new short treatment plan with bedaquiline and other antibiotics can help people in China with multidrug-resistant tuberculosis feel better compared to a treatment plan without bedaquiline.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Chest Hospital Academic / other |
| Locations | 17 sites (Beijing and 16 other locations) |
| Trial ID | NCT05306223 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of a short-course regimen that includes bedaquiline for treating patients with multidrug-resistant tuberculosis (MDR-TB) compared to a regimen that does not include bedaquiline. Participants will be those with confirmed pulmonary MDR-TB, and the study will assess outcomes at the end of treatment. The regimen will also include other antibiotics such as levofloxacin, linezolid, cycloserine, and clofazimine. The trial is conducted in various hospitals in China.
Who should consider this trial
Good fit: Ideal candidates are individuals with confirmed pulmonary multidrug-resistant tuberculosis who have not previously been treated with bedaquiline.
Not a fit: Patients who have received prior treatment with bedaquiline or have significant laboratory abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and safer option for patients suffering from multidrug-resistant tuberculosis.
How similar studies have performed: Other studies have shown promise with bedaquiline in treating multidrug-resistant tuberculosis, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Has a positive sputum Mycobacterium tuberculosis culture from a test performed at screening * Has microbiological confirmation of rifampicin resistance by GeneXpert and to isoniazid (INH) via molecular drug-susceptibility testing (DST) showing katG mutation * Has a chest imaging result compatible with a diagnosis of pulmonary Tuberculosis (TB) * Agrees to use effective contraception during the 40-week study treatment phase. A female participant must be: of nonchildbearing potential; of childbearing potential and practicing effective methods of contraception during the 40-week study treatment phase * Is willing to undergo human immunodeficiency virus (HIV) testing Exclusion Criteria: * Has received prior treatment with bedaquiline * Has prior exposure to at least 1 second-line drug in the regimen for at least 4 weeks * Has any grade 3 or 4 laboratory abnormality as confirmed by a clinical expert * Has a known allergy or intolerance to bedaquiline or other drugs in the regimen * Is infected with a strain of nontuberculous mycobacteria * Is HIV-positive
Where this trial is running
Beijing and 16 other locations
- Beijing Chest Hospital — Beijing, China (Recruiting)
- The Eighth Medical Center of PLA General Hospital — Beijing, China (Recruiting)
- Changsha Central Hospital — Changsha, China (Recruiting)
- Public health clinical medical center of Chengdu — Chengdu, China (Recruiting)
- Chongqing Public Health Medical Center — Chongqing, China (Recruiting)
- The Pulmonary Hospital of Fuzhou in Fujian Province（The tuberculosis control and prevention Hospital of Fuzhou in Fujian Province） — Fuzhou, China (Recruiting)
- Guiyang Public Health Clinical Center — Guiyang, China (Recruiting)
- Anhui Chest Hospital — Hefei, China (Recruiting)
- Infectious Disease Hospital of Heilongjiang Province — Heilongjiang, China (Recruiting)
- Jiamusi Tumor Hospital — Jiamusi, China (Not_yet_recruiting)
- Jiangxi Chest Hospital — Jiangxi, China (Not_yet_recruiting)
- Shandong public health clinical center — Shandong, China (Recruiting)
- Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)
- Shenyang Chest Hospital — Shenyang, China (Recruiting)
- Wuhan Pulmonary Hospital — Wuhan, China (Recruiting)
- Xi'an Chest Hospital — Xi'an, China (Recruiting)
- The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, China (Recruiting)
Study contacts
- Principal investigator: Mengqiu Gao — Beijing Chest Hospital
- Study coordinator: Jingtao Gao, PhD
- Email: jingtaogao@outlook.com
- Phone: +8610-89509131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.