Clinical trial NCT06811012: Phase II Clinical Study of Contezolid for the Treatment of Bone and Joint Tuberculosis
Official title: Phase II Clinical Study of Contezolid for the Treatment of Bone and Joint Tuberculosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Tuberculosis
Bone
Joint
Keywords: Contezolid
tuberculosis
bone
joint
Lead sponsor: Beijing Chest Hospital
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: concentration tests will be conducted on both blood and lesion tissue samples.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute
state: Beijing
Study officials:
References: