Mycobacterium Avium Complex Pulmonary DiseasePhase 4CONTE-MACNCT07084402
Short-term Bactericidal Effect of Contezolid in MAC-PD
A Phase 4 study testing Contezolid, Azithromcyin and Rifampicin (RIF) in people with Mycobacterium Avium Complex Pulmonary Disease, run by Bin Cao at 3 sites in China.
Trial summary
The goal of this clinical trial is to learn if contezolid works to treat mycobacterium avium complex pulmonary disease in adults. It will also learn about the safety of contezolid. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mycobacterium Avium Complex Pulmonary Disease
- What is being tested?
- Contezolid, Azithromcyin and Rifampicin (RIF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 3 sitesChina
- Study dates
- 24 Jul 2025to 31 Dec 2027
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily participate in this study and sign the Informed Consent Form.
- Age ≥ 18 years and ≤75 years; gender unrestricted.
- Confirmed diagnosis of MAC pulmonary disease per ATS/IDSA 2020 guidelines or Chinese Guidelines for Diagnosis and Treatment of Nontuberculous Mycobacterial Diseases (2020 edition), with imaging features consistent with nodular bronchiectatic type.
- No prior anti-MAC treatment within the 3 months preceding screening.
- For premenopausal women of childbearing potential who are not surgically sterile:
- Must use a medically accepted contraceptive method (e.g., intrauterine device, hormonal contraception, or condom) during the study period and for 3 months following the last dose of investigational treatment.
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- Serum or urine human chorionic gonadotropin (hCG) test must be negative within 72 hours prior to enrollment.
- Must not be breastfeeding. Male patients with partners of childbearing potential must use effective contraception during the study period and for 3 months after the last dose.
- Organ function criteria met within one week prior to enrollment:
- Hemoglobin ≥60 g/L; ii. Neutrophil count ≥0.5 × 10⁹/L; iii. Platelet count ≥60 × 10⁹/L; iv. Serum total bilirubin ≤3 × upper limit of normal (ULN); v. Aspartate aminotransferase (AST) ≤3 × ULN; vi. Alanine aminotransferase (ALT) ≤3 × ULN; vii. Serum creatinine <2 × ULN OR creatinine clearance ≥60 mL/min; viii. Blood urea nitrogen (BUN) ≤200 mg/L; ix. Urinalysis: Proteinuria <++; if proteinuria is +, 24-hour total protein must be <500 mg.
- Fasting blood glucose within normal range OR stable glycemic control in diabetic patients.
- Cardiac function: No myocardial infarction in the preceding 6 months; No unstable angina or severe arrhythmias; New York Heart Association (NYHA) functional class >II.
Who cannot join
- History of allergy to any study drug in the treatment regimen.
- Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses (e.g., HIV coinfection).
- Presence of congenital/acquired immunodeficiency disorders, active pulmonary malignancy (primary or metastatic), or other malignancies requiring chemotherapy/radiation therapy during the screening or study period.
- History of solid organ transplantation.
- Currently undergoing dialysis.
- Uncontrolled radiation pneumonitis requiring steroid or immunoglobulin pulse therapy, active interstitial lung disease with clinical evidence, uncontrolled and significant pleural effusion or pericardial effusion.
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- Unstable systemic comorbidities including:
- Hypertensive crisis; Unstable angina; Congestive heart failure (NYHA Class III/IV); Myocardial infarction within the preceding 6 months; Severe psychiatric disorders requiring medication (e.g., schizophrenia, bipolar disorder); Severe hepatic or renal dysfunction (e.g., Child-Pugh Class C cirrhosis, eGFR <30 mL/min/1.73m²); Neurodegenerative diseases (e.g., Alzheimer's disease).
- Poor gastrointestinal function or malabsorption syndrome.
- Receipt of other investigational drugs within 4 weeks prior to the first study drug administration.
- Concurrent participation in another interventional clinical trial, unless it is an observational/noninterventional study OR follow-up phase of a completed intervention trial.
- Any physical examination findings or clinical tests deemed by the investigator as likely to:
- Interfere with study results; Increase risks of complications during treatment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 2 recruiting
- Active, not recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Siwei Gu, M.D., 86 10 84205566, orbitline2@gmail.com
- Recruiting
Jiangxi Provincial Chest Hospital
Nanchang, Jiangxi
Chunhong Zhou, 86 0791 86766420
About this study
Official title: Short-term Bactericidal Effect of Contezolid in Mycobacterium Avium Complex Pulmonary Disease
The goal of this clinical trial is to learn if contezolid works to treat mycobacterium avium complex pulmonary disease in adults. It will also learn about the safety of contezolid. The main questions it aims to answer are:
Does adding contezolid to standard regimen further decrease the bacterial load in patients' sputum compared with current standard regimen? What medical problems do participants have when taking contezolid along with standard regimen? Researchers will compare standard regimen plus contezolid to standard regimen alone to see if contezolid helps further lower the count of bacteria in patients' sputum.
Read more
Participants will:
Take contezolid and standard regimen (azithromycin, ethambutol and rifampicin) or standard regimen only for 6 months, contezolid is administered every day while other drugs are taken 3 times a week Visit the clinic once every 1 month for checkups and tests.
- Being tested
- Contezolid, Azithromcyin, Rifampicin (RIF), Ethambutol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContezolidDrug
contezolid 800mg po q12h for 6 months
AzithromcyinDrug
azithromycin 500mg po tiw (250mg po tiw if weight below 50kg) for 6 months.
Rifampicin (RIF)Drug
rifampicin 600mg po tiw for 6 months.
EthambutolDrug
ethambutol 25mg/kg po tiw for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Contezolid plus standard regimen | Experimental | Participants in this arm will receive contezolid 800mg po q12h, azithromycin 500mg po tiw (250mg po tiw if weight below 50kg), rifampicin 600mg po tiw and ethambutol 25mg/kg po tiw for 6 months. Receives: Drug: Contezolid; Drug: Azithromcyin; Drug: Rifampicin (RIF); Drug: Ethambutol |
| Standard regimen | Active comparator | Participants in this arm will receive azithromycin 500mg po tiw (250mg po tiw if weight below 50kg), rifampicin 600mg po tiw and ethambutol 25mg/kg po tiw for 6 months. Receives: Drug: Azithromcyin; Drug: Rifampicin (RIF); Drug: Ethambutol |
What is being measured
The primary outcome is the main question the study is designed to answer.
time-to-positivity of sputum mycobacterium culture
Measured: the end of month 3
Secondary outcomes (4)
culture conversion
Measured: at the end of month 3 and 6
time to first culture conversion
Measured: from enrollment to the end of month 6
CT status of the lesion
Measured: at the end of month 3 and 6
adverse events
Measured: from enrollment to the end of month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start24 Jul 2025
- Primary completion24 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Avium Complex Pulmonary DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Cao
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chest Hospital, Capital Medical University, Jiangxi Chest Hospital, MicuRx, Guangzhou Chest Hospital., Anhui Chest Hospital, Changsha Central Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Weifang Second People's Hospital, Shandong Public Health Clinical Center
- Responsible party
- Sponsor-investigator, Bin Cao, Capital Medical University
- Investigators
- Xiaojing Cui, M.D., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084402
- Sponsor's protocol ID
- 2025-HX-59
- Acronym
- CONTE-MAC
- Status last verified
- Nov 2026
- First submitted
- 17 Jul 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Bactericidal Effect of Contezolid in Mycobacterium Avium Complex Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07084402
- Acronym / sponsor ID
- CONTE-MAC / 2025-HX-59
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Bin CaoUniversity, hospital or other
- Collaborators
- Beijing Chest Hospital, Capital Medical University, Jiangxi Chest Hospital, MicuRx, Guangzhou Chest Hospital., Anhui Chest Hospital, Changsha Central Hospital, Shanghai Pulmonary Hospital, Shanghai, China, Weifang Second People's Hospital, Shandong Public Health Clinical Center
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 24 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Jul 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.
The goal of this clinical trial is to learn if contezolid works to treat mycobacterium avium complex pulmonary disease in adults. It will also learn about the safety of contezolid. The main questions it aims to answer are:
Does adding contezolid to standard regimen further decrease the bacterial load in patients' sputum compared with current standard regimen? What medical problems do participants have when taking contezolid along with standard regimen? Researchers will compare standard regimen plus contezolid to standard regimen alone to see if contezolid helps further lower the count of bacteria in patients' sputum.
Participants will:
Take contezolid and standard regimen (azithromycin, ethambutol and rifampicin) or standard regimen only for 6 months, contezolid is administered every day while other drugs are taken 3 times a week Visit the clinic once every 1 month for checkups and tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contezolid plus standard regimen | Experimental | Drug: Contezolid, Drug: Azithromcyin, Drug: Rifampicin (RIF), Drug: EthambutolParticipants in this arm will receive contezolid 800mg po q12h, azithromycin 500mg po tiw (250mg po tiw if weight below 50kg), rifampicin 600mg po tiw and ethambutol 25mg/kg po tiw for 6 months. |
| Standard regimen | Active comparator | Drug: Azithromcyin, Drug: Rifampicin (RIF), Drug: EthambutolParticipants in this arm will receive azithromycin 500mg po tiw (250mg po tiw if weight below 50kg), rifampicin 600mg po tiw and ethambutol 25mg/kg po tiw for 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients voluntarily participate in this study and sign the Informed Consent Form.
- Age ≥ 18 years and ≤75 years; gender unrestricted.
- Confirmed diagnosis of MAC pulmonary disease per ATS/IDSA 2020 guidelines or Chinese Guidelines for Diagnosis and Treatment of Nontuberculous Mycobacterial Diseases (2020 edition), with imaging features consistent with nodular bronchiectatic type.
- No prior anti-MAC treatment within the 3 months preceding screening.
- For premenopausal women of childbearing potential who are not surgically sterile:
Key exclusion criteria (13 listed)
- History of allergy to any study drug in the treatment regimen.
- Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses (e.g., HIV coinfection).
- Presence of congenital/acquired immunodeficiency disorders, active pulmonary malignancy (primary or metastatic), or other malignancies requiring chemotherapy/radiation therapy during the screening or study period.
- History of solid organ transplantation.
- Currently undergoing dialysis.
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 po q12h for 6 months | Drug | Contezolid plus standard regimen |
| Azithromcyinazithromycin 500mg po tiw (250mg po tiw if weight below 50kg) for 6 months. | Drug | Contezolid plus standard regimen, Standard regimen |
| Rifampicin (RIF)rifampicin 600mg po tiw for 6 months. | Drug | Contezolid plus standard regimen, Standard regimen |
| Ethambutolethambutol 25mg/kg po tiw for 6 months. | Drug | Contezolid plus standard regimen, Standard regimen |
Primary outcome
time-to-positivity of sputum mycobacterium culture
Time frame: the end of month 3
4 secondary outcomes
culture conversion
Time frame: at the end of month 3 and 6
time to first culture conversion
Time frame: from enrollment to the end of month 6
CT status of the lesion
Time frame: at the end of month 3 and 6
adverse events
Time frame: from enrollment to the end of month 6
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Xiaojing Cui, M.D. principal investigator
China-Japan Friendship Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contezolid, Azithromcyin and Rifampicin (RIF) in people with Mycobacterium Avium Complex Pulmonary Disease, run by Bin Cao at 3 sites 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 12 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Siwei Gu, M.D. (86 10 84205566, orbitline2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time-to-positivity of sputum mycobacterium culture (time frame: the end of month 3). 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 5 Nov 2026.