Phase II Clinical Study of Contezolid for the Treatment of Bone and Joint Tuberculosis

Phase 1

• Conditions: Tuberculosis; Bone; Joint
• Interventions: Drug: Contezolid; Drug: Linezolid (LZD)

• Registration Number: NCT06811012
• Lead Sponsor: Beijing Chest Hospital

Brief Summary

Contezolid is a novel oxazolidinone antibacterial agent that has shown promising application prospects in the field of tuberculosis treatment in recent years. Studies have demonstrated that contezolid exhibits comparable anti-tuberculosis activity to linezolid both in vitro and in vivo, and even superior intracellular bactericidal activity against Mycobacterium tuberculosis. More importantly, contezolid significantly reduces the risks of bone marrow suppression toxicity, neurotoxicity, and lactic acidosis compared to linezolid, thereby enhancing the drug's safety and tolerability.

In the treatment of bone and joint tuberculosis, contezolid, as a new anti-tuberculosis drug, holds potential significant value. Firstly, it can provide new options for the treatment of drug-resistant Mycobacterium tuberculosis, improving treatment outcomes. Secondly, its lower toxic and side effects can enhance patient compliance, ensuring the smooth progress of treatment. Additionally, contezolid may exhibit synergistic effects with other anti-tuberculosis drugs, further optimizing treatment regimens. Therefore, conducting research on the application of contezolid in the treatment of bone and joint tuberculosis not only helps to improve the cure rate of the disease but also may open up new avenues for the treatment of tuberculosis.

The aim of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of contezolid in the treatment of bone and joint tuberculosis.

Detailed Description

Contezolid is a novel oxazolidinone antibacterial agent that has shown promising application prospects in the field of tuberculosis treatment in recent years. Studies have demonstrated that contezolid exhibits comparable anti-tuberculosis activity to linezolid both in vitro and in vivo, and even superior intracellular bactericidal activity against Mycobacterium tuberculosis. More importantly, contezolid significantly reduces the risks of bone marrow suppression toxicity, neurotoxicity, and lactic acidosis compared to linezolid, thereby enhancing the drug's safety and tolerability.

In the treatment of bone and joint tuberculosis, contezolid, as a new anti-tuberculosis drug, holds potential significant value. Firstly, it can provide new options for the treatment of drug-resistant Mycobacterium tuberculosis, improving treatment outcomes. Secondly, its lower toxic and side effects can enhance patient compliance, ensuring the smooth progress of treatment. Additionally, contezolid may exhibit synergistic effects with other anti-tuberculosis drugs, further optimizing treatment regimens. Therefore, conducting research on the application of contezolid in the treatment of bone and joint tuberculosis not only helps to improve the cure rate of the disease but also may open up new avenues for the treatment of tuberculosis.

The aim of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of contezolid in the treatment of bone and joint tuberculosis.

Study Timeline

• Study Start: 2024-01-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• (1) Inpatients who have been diagnosed or clinically diagnosed with bone and joint tuberculosis within the past 3 months prior to screening; (2) Voluntarily participate in this study and sign the informed consent form; (3) Male and female participants must use effective contraception during the study and for 1 month after the study ends.

Exclusion Criteria

• (1) Patients who have been on long-term corticosteroid therapy or taking immunosuppressants within 90 days prior to screening; (2) Pregnant women, postpartum women, and lactating women; (3) Patients with a history of allergy or known hypersensitivity to contezolid or linezolid, or a history of severe adverse reactions; (4) Evidence of resistance to contezolid or linezolid; (5) Patients deemed unsuitable for participation in this study by the investigator's assessment; (6) Patients whom the investigator believes participation in this study would harm their health, or who are deemed unable to comply with the scheduled visits and assessments as outlined in the protocol, and therefore unsuitable for participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contezolid	Contezolid	Contezolid 800mg QD for 14 days
linezolid	Linezolid (LZD)	Linezolid 600mg QD for 14 days.

Primary Outcome Measures

Name	Time	Method
concentration tests will be conducted on both blood and lesion tissue samples.	14 days	After 14 days of oral treatment with contezolid or linezolid, patients will undergo surgery or puncture to obtain tissue from the site of the bone and joint tuberculosis lesion, and concentration tests will be conducted on both blood and lesion tissue samples.

Trial Locations

Locations (1)

Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute; 🇨🇳 Beijing, Beijing, China