Phase II Clinical Study of Contezolid for the Treatment of Bone and Joint Tuberculosis
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 101149
- Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Contezolid
Contezolid 800mg QD for 14 days
|
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. |
|
Active Comparator: linezolid
Linezolid 600mg QD for 14 days.
|
Linezolid 600mg QD for 14 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
concentration tests will be conducted on both blood and lesion tissue samples.
Time Frame: 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.
|
14 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Tuberculosis, Extrapulmonary
- Bone Diseases
- Musculoskeletal Diseases
- Infections
- Bone Diseases, Infectious
- Gram-Positive Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis
- Tuberculosis, Osteoarticular
- Anti-Bacterial Agents
- Anti-Infective Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Linezolid
Other Study ID Numbers
- GCP-TB-2024-1-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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