NCT06811025Enrolling by invitationPhase 1/2
Phase II Clinical Study of Contezolid for the Treatment of Tuberculous Meningitis
Source: ClinicalTrials.gov · Last updated 6 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 31 Jan 2025
- Start date
- 1 Feb 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Beijing Chest Hospital
- Diseases
- Tuberculosis
- NCT number
- NCT06811025
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 24
- From 1 Feb 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (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.
Who the study is looking for
- (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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.