Early bactericidal activity, safety and tolerance of Contezolid tablets in patients of newly diagnosed sensitive pulmonary tuberculosis and multidrug-resistant pulmonary tuberculosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100053968

Enrollment

Unknown

Registered

2021-12-04

Start date

2021-12-15

Completion date

Unknown

Last updated

2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary tuberculosis

Interventions

Experimental group1:sensitive group: Contezolid tablets or Linezolid tablets

Experimental group2:multidrug-resistant group: Contezolid tablets or Linezolid tablets

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Initial treatment sensitive group: 1. Aged 18 to 65 years; 2. Diagnosed as newly-treated sensitive pulmonary tuberculosis, and drug sensitivity suggests rifampicin sensitivity; 3. Positive sputum smear or culture within 1 month before enrollment, and the bacterial type identification confirmed to be Mycobacterium tuberculosis; 4. Not treated with anti-tuberculosis drugs; 5. Fasting blood sugar is less than 7.0mmol/L. 6. Be able to understand and sign the informed consent form. MDR group: 1. Aged 18 to 65 years; 2. Diagnosed as MDR-TB, and quinolone resistance is excluded; 3. Positive sputum smear or culture within 2 months before enrollment, and the bacterial type identification confirmed to be Mycobacterium tuberculosis; 4. No second-line anti-tuberculosis drug treatment, or treatment for less than 1 month; 5. Fasting blood sugar is less than 7.0mmol/L. 6. Be able to understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to any drug in the program; 2. HIV-infected persons; 3. Patients with severe extrapulmonary tuberculosis; 4. Participated in other clinical studies within 8 weeks before the start of the experiment; 5. Complications such as severe diabetes and immune-compromised diseases; 6. Combined with serious heart, liver, kidney, blood and other diseases, pregnancy, breastfeeding, etc.; 7. The doctor believes that there are circumstances that are not suitable for participating in clinical research.

Design outcomes

Primary

Measure	Time frame
Blood routine;visual acuity;electromyograph;Tolerability of long-term use of contezolid versus linezolid;	—

Countries

China

Contacts

Public ContactYao Lan

Shanghai Pulmonary Hospital

spectium1981@126.com+86 17317756391

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026