Early bactericidal activity and pharmacokinetics of Contezolid in patients with drug-resistant pulmonary tuberculosis.

Early bactericidal activity and pharmacokinetics of Contezolid in patients withdrug-resistant pulmonary tuberculosis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300074581

Enrollment

Unknown

Registered

2023-08-10

Start date

2023-08-01

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Multi-drug resistant pulmonary tuberculosis

Interventions

Group A:Single Contezolid 800mg, Q12h, PO,14 days. Followed by Contezolid-included regimen for 14 days.

Group B:Single Contezolid 400mg, Q12h, PO,14 days. Followed by Contezolid-included regimen for 14 days.

Group C:Single linezolid 400mg, Q12h, PO,14 days. Followed by linezolid-included regimen for 14 days.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Male/Female, age 18 years -70 years 2. RR/MDR confirmed by molecular test or phenotypic drug susceptible test. 3. Volunteer to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. HIV co-infection treated with HARRT, multiple underlying diseases, chronic liver diseases, and cancer. 2. With a history of Alcohol dependence or drug abuse, or the researcher believes that participating in this study will harm the patient's health, or that the patient cannot comply with the schedule in the program; 3. A history of allergy or known Hypersensitivity reaction or serious adverse reaction of Linezolid or Contezolid 4. Patients who might have lung surgery during the trial; 5. Body mass index (BMI)<17 kg/m2; 6. Prohibited concomitant medications may continue to be used during the trial. Not suitable for participation in thestudy according to the judgement from the researcher. 7. Patients taking Immunosuppressive drug 8. Patients with organ transplantation 9. Pregnant women, postpartum and lactating patients. 10. Serious complications, hemoptysis, disseminated tuberculosis or sever extrapulmonary tuberculosis 11. Patients with abnormal QT/QTc intervals in the electrocardiogram. 12. Overnight sputum volume less than 10ml

Design outcomes

Primary

Measure	Time frame
Early bactericidal activity of Contezolid;	—

Secondary

Measure	Time frame
Safety indicators;AE incidence rate;Pharmacokinetic indicators;	—

Countries

China

Contacts

Public ContactPeize Zhang

The Third People's Hospital of Shenzhen

82880246@qq.com+86 755 6122 2333

Outcome results

None listed

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