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Study on the use of contezolid as alternative therapy in patients with rifampicin-resistant pulmonary tuberculosis for whom linezolid is not applicable

Study on the use of contezolid as alternative therapy in patients with rifampicin-resistant pulmonary tuberculosis for whom linezolid is not applicable

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090645
Enrollment
Unknown
Registered
2024-10-10
Start date
2024-07-23
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

tuberculosis

Interventions

Contezolid Group:1) For patients with severe adverse reactions due to linezolid, Linezolid should be discontinued, and after symptomatic treatment of adverse reactions (about 7 days), Contezolid (800m

Sponsors

Guangzhou Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old =75 years old, male or female; 2. 40KG= weight =90KG; 3. Patients with clinically diagnosed rifampicin-resistant pulmonary tuberculosis who do not use oxazolidinone-containing drug therapy and do not have other better alternatives. 4. Patients who have been on an anti-tuberculosis regimen containing linezolid for more than 1 month, have developed thrombocytopenia, anemia, or peripheral neuropathy during treatment, and have been assessed as unsuitable for continued use of linezolid. Or patients who need to use oxazolidinone as an anti-tuberculosis regimen, but are assessed not suitable for linezolid due to a history of myelopathic depression, optic neuritis, peripheral neuropathy, etc.; 5. Test negative for HIV.

Exclusion criteria

Exclusion criteria: 1. Allergic to oxazolidinones; 2. Drug sensitivity showed resistance to linezolid; 3. Severe renal insufficiency (creatinine clearance (CrCl) less than 30 mL/min); 4. Moderate liver function impairment (ALT and/or AST levels above 3 times the upper limit of the laboratory reference value, if temporarily elevated, can be enrolled after treatment recovery); 5. Inability to attend or comply with treatment and accompanying visitors; 6. Have a history of severe cardiovascular disease or are suffering from such disease, such as heart failure, hypertension (poorly controlled blood pressure), arrhythmia or post-myocardial infarction status; 7. Pregnant or lactating women; 8. Hiv-positive or AIDS patients; 9. Patients with a history of allergy to more than 2 drugs; 10. Tuberculosis bacteria drug resistance degree is serious, can not form an effective background program patients; 11. Patients who have undergone clinical drug trials within the past 1 year; 12. Patients who lack self-awareness or are unable to walk; 13. Patients with less than primary education or who are unable to write; 14. Patients with advanced malignant tumors; 15. Patients who refuse to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Phlegm cultivation turned negative;

Secondary

MeasureTime frame
Chest imaging;

Countries

China

Contacts

Public ContactZhang Hong

Guangzhou Chest Hospital

naozhangde@sina.com+86 137 1039 3964

Outcome results

None listed

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