Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase II Clinical Study of Contezolid for the Treatment of Bone and Joint Tuberculosis
Sponsor: Beijing Chest Hospital
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-01-31
Completion Date
2025-12-31
Last Updated
2025-02-06
Healthy Volunteers
No
Conditions
Interventions
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.
Linezolid (LZD)
Linezolid 600mg QD for 14 days.
Locations (1)
Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute
Beijing, Beijing Municipality, China