Phase II Clinical Study of Contezolid for the Treatment of Tuberculous Meningitis

Contezolid is a novel oxazolidinone antibiotic developed by Shanghai Mengke Pharmaceutical Co., Ltd., which successfully went public in 2021. It inhibits bacterial growth by interfering with protein synthesis through its translational inhibitory effect on bacteria. Contezolid has demonstrated promising clinical results in patients with drug-resistant tuberculosis, making it a powerful tool in the fight against drug-resistant tuberculosis.

Currently, there is a lack of pharmacokinetic data on contezolid in patients with central nervous system tuberculosis. Some studies have reported the steady-state concentrations of contezolid in the serum and cerebrospinal fluid (CSF) of tuberculous meningitis patients receiving multidrug therapy, showing that the concentration of contezolid in the CSF exceeds the minimum inhibitory concentration against Mycobacterium tuberculosis, and the unbound fraction has a high penetration rate.

In summary, as a novel anti-tuberculosis drug, contezolid has significant potential value in the treatment of tuberculous meningitis. The implementation of this project will help further explore the application prospects of contezolid in the treatment of tuberculous meningitis and provide a safer and more effective treatment option for clinical use.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tuberculosis; Meningitis
• Intervention / Treatment: Drug: Contezolid; Drug: Linezolid (LZD)

Detailed Description

Contezolid is a novel oxazolidinone antibiotic developed by Shanghai Mengke Pharmaceutical Co., Ltd., which successfully went public in 2021. It inhibits bacterial growth by interfering with protein synthesis through its translational inhibitory effect on bacteria. Contezolid has demonstrated promising clinical results in patients with drug-resistant tuberculosis, making it a powerful tool in the fight against drug-resistant tuberculosis.

Strong anti-tuberculosis activity: Contezolid exhibits comparable anti-tuberculosis activity to linezolid both in vitro and in vivo, and even superior intracellular bactericidal activity against Mycobacterium tuberculosis.

High safety: Contezolid significantly reduces the risks of bone marrow suppression toxicity, neurotoxicity, and lactic acidosis compared to linezolid, bringing new hope to patients who cannot continue traditional therapy due to adverse drug reactions.

Broad application prospects: With the further accumulation of clinical data and in-depth research, the application prospects of contezolid in anti-tuberculosis treatment will undoubtedly be broader. Especially for patients who experience severe adverse reactions and cannot continue using linezolid, contezolid provides a new treatment option.

Currently, there is a lack of pharmacokinetic data on contezolid in patients with central nervous system tuberculosis. Some studies have reported the steady-state concentrations of contezolid in the serum and cerebrospinal fluid (CSF) of tuberculous meningitis patients receiving multidrug therapy, showing that the concentration of contezolid in the CSF exceeds the minimum inhibitory concentration against Mycobacterium tuberculosis, and the unbound fraction has a high penetration rate.

In summary, as a novel anti-tuberculosis drug, contezolid has significant potential value in the treatment of tuberculous meningitis. The implementation of this project will help further explore the application prospects of contezolid in the treatment of tuberculous meningitis and provide a safer and more effective treatment option for clinical use.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • 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: No

Description

Inclusion Criteria:

• (1) Inpatients who have been diagnosed with or clinically diagnosed with tuberculous meningitis 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, patients in the puerperium, 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) Patients with 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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: linezolid	Drug: Linezolid (LZD); Linezolid 600mg once daily (QD) for 7 days.
Experimental: Contezolid	Drug: Contezolid; Contezolid 800mg once daily (QD) for 7 days;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
After 7 days of oral treatment with contezolid/linezolid, the patients underwent lumbar puncture to obtain cerebrospinal fluid (CSF) samples, and concentration tests were conducted on both blood and CSF samples.	After 7 days of oral treatment with contezolid/linezolid, the patients underwent lumbar puncture to obtain cerebrospinal fluid (CSF) samples, and concentration tests were conducted on both blood and CSF samples.	7 days

Collaborators and Investigators

• Sponsor: Beijing Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Tuberculous meningitis; contezolid
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Tuberculosis, Extrapulmonary; Central Nervous System Diseases; Nervous System Diseases; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Infections; Actinomycetales Infections; Mycobacterium Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Tuberculosis, Central Nervous System; Meningitis; Tuberculosis; Tuberculosis, Meningeal; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Synthesis Inhibitors; Linezolid
• Other Study ID Numbers: GCP-TB-2024-2-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In our institution, it is not allowed to post hospital information and patient information on websites for public disclosure.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No