MonotherapyPhase 2NCT07372781
Clinical Study on the Early Bactericidal Activity of Contezolid Against Mycobacterium Abscessus Disease
A Phase 2 study testing Contezolid and linezolid in people with Monotherapy and Mycobacterium Abscessus Infection, run by Beijing Chest Hospital at 1 site in China.
Trial summary
This study is a single-center, randomized, controlled, open-label clinical trial designed to assess the early bactericidal activity of a single agent, contezolid, in patients with Mycobacterium abscessus infections. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Monotherapy, Mycobacterium Abscessus Infection
- What is being tested?
- Contezolid and linezolid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Phase 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged between 18 and 65 years old;
- Weight ranging from 40 kg to 90 kg;
- At least one positive sputum culture for Mycobacterium abscessus within 6 months prior to screening, and one positive sputum culture for Mycobacterium abscessus with molecular species identification during the screening period within 1 month prior to the study;
- Voluntary participation in this study and signing of the informed consent form; (5) Male and female participants must use effective contraception during the study and for 1 month after the study ends.
Who cannot join
- Patients who have been on long-term corticosteroid therapy or taking immunosuppressants within 90 days prior to screening;
- Pregnant women, postpartum women, and lactating patients;
- Patients with a history of bedaquiline allergy or known hypersensitivity, or a history of severe adverse reactions;
- Patients with evidence of bedaquiline resistance;
- Patients deemed unsuitable for participation in this study by the investigator's assessment;
- Patients whom the investigator believes participation in this study would harm their health, or who are unlikely to comply with the scheduled visits and assessments as outlined in the protocol, and therefore are not suitable 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
This study is a single-center, randomized, controlled, open-label clinical trial designed to assess the early bactericidal activity of a single agent, contezolid, in patients with Mycobacterium abscessus infections. Patients were administered contezolid monotherapy for 14 days specifically targeting Mycobacterium abscessus, and were compared to a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug. The comparison was conducted through the analysis of colony forming units counts and Time To Positivity in sputum cultures. By evaluating the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus infections, this study aimed to assess the early bactericidal activity of contezolid, thereby providing a basis for the selection of new therapeutic options for the treatment of patients with Mycobacterium abscessus infections.
Read the detailed description
As one of the drugs for treating Mycobacterium abscessus infections, linezolid is effective but its use is limited in anti-Mycobacterium abscessus treatment regimens due to the high incidence of adverse reactions associated with long-term use. Contezolid, a new drug developed in China, belongs to the oxazolidinone class of drugs and shares a similar antibacterial spectrum with linezolid, while exhibiting a significantly better safety profile. This study is a single-center, randomized, controlled, open-label clinical trial designed to evaluate the early bactericidal activity. It enrolls patients with Mycobacterium abscessus disease and administers a 14-day monotherapy of contezolid for the treatment of the disease. The study compares contezolid with linezolid, a classic anti-Mycobacterium abscessus drug, by analyzing colony forming units and Time To Positivity in sputum cultures. By assessing the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus disease, the study evaluates the early bactericidal activity of contezolid, providing a basis for the selection of new therapeutic options for the treatment of Mycobacterium abscessus disease.
- Conditions
- Monotherapy, Mycobacterium Abscessus Infection
- Being tested
- Contezolid, linezolid
- Keywords
- early bactericidal activity, colony forming units, Time To Positivity, Mycobacterium abscessus
- Medical subject headings
- Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContezolidDrug
Also called Oxazolidinone
Patients with Mycobacterium abscessus infections were enrolled and treated with a 14-day monotherapy of contezolid for anti-Mycobacterium abscessus therapy, through analysis and comparison of colony forming units and Time To Positivity in sputum cultures.
linezolidDrug
Also called Oxazolidinone
Patients with Mycobacterium abscessus infections were enrolled and treated with a 14-day monotherapy of linezolid for anti-Mycobacterium abscessus therapy, through analysis and comparison of colony forming units and Time To Positivity in sputum cultures.
| Study group | Role | What they receive |
|---|---|---|
| Contezolid group | Experimental | Contezolid 800mg twice daily for 14 days. To enroll 12 patients with Mycobacterium abscessus infections, who will receive continuous administration of contezolid for 14 days. Sputum samples will be collected for colony forming units counting and Time To Positivity observation to evaluate the Early Bactericidal Activity. Receives: Drug: Contezolid |
| Linezolid group | Active comparator | Linezolid 600mg once daily for 14 days. To enroll 12 patients with Mycobacterium abscessus infections, who will receive continuous administration of linezolid for 14 days. Sputum samples will be collected for colony forming units counting and Time To Positivity observation to evaluate the Early Bactericidal Activity. Receives: Drug: linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Positivity in sputum cultures
With a 14-day monotherapy of contezolid for anti-Mycobacterium abscessus therapy, then were compared with a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug, through analysis and comparison of Time To Positivity in sputum cultures.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MonotherapyStudies 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 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
- Investigators
- Wenjuan Nie, Director, Study director, Beijing Tuberculosis & Thoracic Tumor Research Institute Beijing Chest Hospital affiliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372781
- Sponsor's protocol ID
- GCP-TB-2024-11-15
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In our hospital, the investigators are not allowed to casually publish participants' information and hospital data on the website.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Early Bactericidal Activity of Contezolid Against Mycobacterium Abscessus Disease
- ClinicalTrials.gov ID
- NCT07372781
- Acronym / sponsor ID
- GCP-TB-2024-11-15
- Conditions
- Monotherapy, Mycobacterium Abscessus Infection
- Keywords
- early bactericidal activity, colony forming units, Time To Positivity, Mycobacterium abscessus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jan 2026 (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.
This study is a single-center, randomized, controlled, open-label clinical trial designed to assess the early bactericidal activity of a single agent, contezolid, in patients with Mycobacterium abscessus infections. Patients were administered contezolid monotherapy for 14 days specifically targeting Mycobacterium abscessus, and were compared to a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug. The comparison was conducted through the analysis of colony forming units counts and Time To Positivity in sputum cultures. By evaluating the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus infections, this study aimed to assess the early bactericidal activity of contezolid, thereby providing a basis for the selection of new therapeutic options for the treatment of patients with Mycobacterium abscessus infections.
Detailed description
As one of the drugs for treating Mycobacterium abscessus infections, linezolid is effective but its use is limited in anti-Mycobacterium abscessus treatment regimens due to the high incidence of adverse reactions associated with long-term use. Contezolid, a new drug developed in China, belongs to the oxazolidinone class of drugs and shares a similar antibacterial spectrum with linezolid, while exhibiting a significantly better safety profile. This study is a single-center, randomized, controlled, open-label clinical trial designed to evaluate the early bactericidal activity. It enrolls patients with Mycobacterium abscessus disease and administers a 14-day monotherapy of contezolid for the treatment of the disease. The study compares contezolid with linezolid, a classic anti-Mycobacterium abscessus drug, by analyzing colony forming units and Time To Positivity in sputum cultures. By assessing the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus disease, the study evaluates the early bactericidal activity of contezolid, providing a basis for the selection of new therapeutic options for the treatment of Mycobacterium abscessus disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contezolid group | Experimental | Drug: ContezolidContezolid 800mg twice daily for 14 days. To enroll 12 patients with Mycobacterium abscessus infections, who will receive continuous administration of contezolid for 14 days. Sputum samples will be collected for colony forming units counting and Time To Positivity observation to evaluate the Early Bactericidal Activity. |
| Linezolid group | Active comparator | Drug: linezolidLinezolid 600mg once daily for 14 days. To enroll 12 patients with Mycobacterium abscessus infections, who will receive continuous administration of linezolid for 14 days. Sputum samples will be collected for colony forming units counting and Time To Positivity observation to evaluate the Early Bactericidal Activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged between 18 and 65 years old;
- Weight ranging from 40 kg to 90 kg;
- At least one positive sputum culture for Mycobacterium abscessus within 6 months prior to screening, and one positive sputum culture for Mycobacterium abscessus with molecular species identification during the screening period within 1 month prior to the study;
- Voluntary participation in this study and signing of the informed consent form; (5) Male and female participants must use effective contraception during the study and for 1 month after the study ends.
Key exclusion criteria (6 listed)
- Patients who have been on long-term corticosteroid therapy or taking immunosuppressants within 90 days prior to screening;
- Pregnant women, postpartum women, and lactating patients;
- Patients with a history of bedaquiline allergy or known hypersensitivity, or a history of severe adverse reactions;
- Patients with evidence of bedaquiline resistance;
- Patients deemed unsuitable for participation in this study by the investigator's assessment;
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 |
|---|---|---|
| ContezolidAlso: OxazolidinonePatients with Mycobacterium abscessus infections were enrolled and treated with a 14-day monotherapy of contezolid for anti-Mycobacterium abscessus therapy, through analysis and comparison of colony forming units and Time To Positivity in sputum cultures. | Drug | Contezolid group |
| linezolidAlso: OxazolidinonePatients with Mycobacterium abscessus infections were enrolled and treated with a 14-day monotherapy of linezolid for anti-Mycobacterium abscessus therapy, through analysis and comparison of colony forming units and Time To Positivity in sputum cultures. | Drug | Linezolid group |
Primary outcome
Time To Positivity in sputum cultures
Time frame: 14 days
With a 14-day monotherapy of contezolid for anti-Mycobacterium abscessus therapy, then were compared with a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug, through analysis and comparison of Time To Positivity in sputum cultures.
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 28 Jan 2026.
- Individual participant dataSharing planned: No. In our hospital, the investigators are not allowed to casually publish participants' information and hospital data on the website.
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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.
Wenjuan Nie, Director study director
Beijing Tuberculosis & Thoracic Tumor Research Institute Beijing Chest Hospital affiliated to Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Contezolid and linezolid in people with Monotherapy and Mycobacterium Abscessus Infection, 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 4 inclusion and 6 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 28 Jan 2026. 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 phase mean?
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?
Time To Positivity in sputum cultures (time frame: 14 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 28 Jan 2026.