TuberculosisPhase 1/2NCT06811025
Phase II Clinical Study of Contezolid for the Treatment of Tuberculous Meningitis
A Phase 1/2 study testing Contezolid and Linezolid (LZD) in people with Tuberculosis and Meningitis, run by Beijing Chest Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis, Meningitis
- What is being tested?
- Contezolid and Linezolid (LZD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute
Beijing, Beijing Municipality, 101149
About this study
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.
Read the 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.
- Conditions
- Tuberculosis, Meningitis
- Being tested
- Contezolid, Linezolid (LZD)
- Keywords
- Tuberculous meningitis, contezolid
- Medical subject headings
- Tuberculosis, Meningitis, Tuberculosis, Meningeal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContezolidDrug
Contezolid 800mg once daily (QD) for 7 days;
Linezolid (LZD)Drug
Linezolid 600mg once daily (QD) for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Contezolid | Experimental | Not described Receives: Drug: Contezolid |
| linezolid | Active comparator | Not described Receives: Drug: Linezolid (LZD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nie WenJuan, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811025
- Sponsor's protocol ID
- GCP-TB-2024-2-1
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In our institution, it is not allowed to post hospital information and patient information on websites for public disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Contezolid for the Treatment of Tuberculous Meningitis
- ClinicalTrials.gov ID
- NCT06811025
- Acronym / sponsor ID
- GCP-TB-2024-2-1
- Conditions
- Tuberculosis, Meningitis
- Keywords
- Tuberculous meningitis, contezolid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contezolid | Experimental | Drug: Contezolid |
| linezolid | Active comparator | Drug: Linezolid (LZD) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ContezolidContezolid 800mg once daily (QD) for 7 days; | Drug | Contezolid |
| Linezolid (LZD)Linezolid 600mg once daily (QD) for 7 days. | Drug | linezolid |
Primary outcome
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.
Time frame: 7 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No. In our institution, it is not allowed to post hospital information and patient information on websites for public disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Contezolid and Linezolid (LZD) in people with Tuberculosis and Meningitis, run by Beijing Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.