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

NCT06811025 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-06

No results posted yet for this study

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

Interventions

DRUG

Contezolid

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

DRUG

Linezolid (LZD)

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

Sponsors & Collaborators

  • Beijing Chest Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06811025 on ClinicalTrials.gov