Phase II Clinical Study of Contezolid for the Treatment of Bone and Joint Tuberculosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Contezolid, Linezolid (LZD).
- Who it may be relevant to
- Registry conditions: Tuberculosis, Bone, Joint. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Contezolid
This study intends to enroll 24 patients with bone and joint tuberculosis, who will be randomly divided into two groups: the contezolid monotherapy group and the linezolid monotherapy group. Patients will receive oral contezolid or linezolid monotherapy for 14 consecutive days, and data on treatment safety, pharmacokinetics, and preliminary efficacy will be collected before and after administration. Study Medications: Contezolid 800mg QD for 14 days; Linezolid 600mg QD for 14 days. - Drug Linezolid (LZD)
Linezolid 600mg QD for 14 days.
Primary outcome measures
- concentration tests will be conducted on both blood and lesion tissue samples. [Time frame: 14 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Th — Beijing
Identifiers
NCT: NCT06811012 · GCP-TB-2024-1-31