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

NCT06811025 | Enrolling By Invitation Phase 1

• 1 other identifier: GCP-TB-2024-2-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tuberculosis; Meningitis

Keywords

Tuberculous meningitis; contezolid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Contezolid

EXPERIMENTAL

Drug: Contezolid

linezolid

ACTIVE COMPARATOR

Drug: Linezolid (LZD)

Interventions

Contezolid DRUG

Contezolid 800mg once daily (QD) for 7 days;

Contezolid

Linezolid (LZD) DRUG

Linezolid 600mg once daily (QD) for 7 days.

linezolid

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Beijing Chest Hospital: lead

Study Sites (1)

Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute

Beijing, Beijing Municipality, 101149, China

Location

MeSH Terms

Conditions

Tuberculosis; Meningitis; Tuberculosis, Meningeal

Interventions

contezolid; Linezolid

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases; Nervous System Diseases; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Tuberculosis, Central Nervous System; Tuberculosis, Extrapulmonary; Central Nervous System Infections; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: February 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)