Mycobacterium Avium Complex Pulmonary DiseasePhase 4NCT07213765
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
A Phase 4 study testing Contezolid, Azithromycin and Ethambutol (E) in people with Mycobacterium Avium Complex Pulmonary Disease, run by Bin Cao at 6 sites in China.
Trial summary
The goal of this clinical trial is to learn if adding contezolid works to shorten the length of treatment in mycobacterium avium pulmonary disease in adults. It will also learn about the safety of extended usage 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, Azithromycin and Ethambutol (E)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 6 sitesChina
- Study dates
- 24 Jul 2025to 31 Dec 2028
- 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
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
- Not yet recruiting
Guangzhou Chest Hospital
Guangzhou, Guangdong
- Recruiting
Anhui Chest Hospital
Hefei, Anhui
- Recruiting
Jiangxi Chest Hospital
Nanchang, Jiangxi
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
About this study
The goal of this clinical trial is to learn if adding contezolid works to shorten the length of treatment in mycobacterium avium pulmonary disease in adults. It will also learn about the safety of extended usage of contezolid. The main questions it aims to answer are:
Does adding contezolid to standard regimen decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease? What medical problems do participants have when taking contezolid for an extended length? Researchers will compare standard regimen plus contezolid to standard regimen alone to see if contezolid helps further decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease?
Read more
Participants will:
Take contezolid and standard regimen (azithromycin, ethambutol, and rifampicin) for 6 months, contezolid is administered every day while other drugs are taken three times a week OR take standard regimen three times a week for 12 months.
Visit the clinic once every 1 month for checkups and tests.
- Being tested
- Contezolid, Azithromycin, Ethambutol (E), Rifampicin (R)
- Keywords
- Mycobacterium Avium Complex Pulmonary Disease, non-tuberculous mycobacterium, contezolid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContezolidDrug
contezolid 800mg po q12h*6m
AzithromycinDrug
azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)*6m
AzithromycinDrug
azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)*12m
Ethambutol (E)Drug
ethambutol 25mg/kg po tiw*6m
Ethambutol (E)Drug
ethambutol 25mg/kg po tiw*12m
Rifampicin (R)Drug
rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)*6m
Rifampicin (R)Drug
rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)*12m
| Study group | Role | What they receive |
|---|---|---|
| Contezolid shortened regimen | Experimental | Not described Receives: Drug: Contezolid; Drug: Azithromycin; Drug: Ethambutol (E); Drug: Rifampicin (R) |
| Standard regimen | Active comparator | Not described Receives: Drug: Azithromycin; Drug: Ethambutol (E); Drug: Rifampicin (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
culture conversion
2 consecutive negative sputum mycobacterial culture at least 4 weeks apart, or one negative bronchoalveolar lavage fluid culture/NGS.
Measured: end of month 6
CT lesion absorption
>30% decrease in lesion size or number of nodules measured on CT
Measured: end of month 6
QOL-B+NTM module
Improvement greater than MID in at least 7 out of 12 domains in QOL-B with NTM-module (must include respiratory symptoms and NTM-PD symptoms)
Measured: end of month 6
Secondary outcomes (5)
culture conversion
2 consecutive negative sputum mycobacterial culture at least 4 weeks apart, or one negative bronchoalveolar lavage fluid culture/NGS.
Measured: up to month 12
CT lesion status
>30% decrease in lesion size or number of nodules measured on CT
Measured: end of month 3, 6, and 12 (for standard regimen)/end of month 3 and 6 (for shortened regimen)
Questionnaire: Quality of life-bronchiectasis (QOL-B) and NTM module
Improvement greater than minimal importance difference in at least 7 out of 12 domains in QOL-B with NTM module (must include respiratory symptoms and NTM-PD symptoms)
Measured: up to month 12
SGRQ
Measured: up to month 12
time to positivity of mycobacterium culture
Measured: up to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start24 Jul 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (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
- MicuRx, Shanghai Pulmonary Hospital, Shanghai, China, Beijing Chest Hospital, Anhui Chest Hospital, Jiangxi Chest Hospital, Guangzhou Chest Hospital., Weifang Second People's Hospital, Shandong Public Health Clinical Center, Changsha Central Hospital
- Responsible party
- Sponsor-investigator, Bin Cao, Capital Medical University
- Investigators
- Xiaojin Cui, M.D., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213765
- Sponsor's protocol ID
- 2025-KY-004
- Status last verified
- Nov 2026
- First submitted
- 19 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 Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07213765
- Acronym / sponsor ID
- 2025-KY-004
- Keywords
- Mycobacterium Avium Complex Pulmonary Disease, non-tuberculous mycobacterium, contezolid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Bin CaoUniversity, hospital or other
- Collaborators
- MicuRx, Shanghai Pulmonary Hospital, Shanghai, China, Beijing Chest Hospital, Anhui Chest Hospital, Jiangxi Chest Hospital, Guangzhou Chest Hospital., Weifang Second People's Hospital, Shandong Public Health Clinical Center, Changsha Central Hospital
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Oct 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 adding contezolid works to shorten the length of treatment in mycobacterium avium pulmonary disease in adults. It will also learn about the safety of extended usage of contezolid. The main questions it aims to answer are:
Does adding contezolid to standard regimen decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease? What medical problems do participants have when taking contezolid for an extended length? Researchers will compare standard regimen plus contezolid to standard regimen alone to see if contezolid helps further decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease?
Participants will:
Take contezolid and standard regimen (azithromycin, ethambutol, and rifampicin) for 6 months, contezolid is administered every day while other drugs are taken three times a week OR take standard regimen three times a week for 12 months.
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 shortened regimen | Experimental | Drug: Contezolid, Drug: Azithromycin, Drug: Ethambutol (E), Drug: Rifampicin (R) |
| Standard regimen | Active comparator | Drug: Azithromycin, Drug: Ethambutol (E), Drug: Rifampicin (R) |
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*6m | Drug | Contezolid shortened regimen |
| Azithromycinazithromycin 500mg po tiw (250mg po tiw for BW under 50kg)*6m | Drug | Contezolid shortened regimen |
| Azithromycinazithromycin 500mg po tiw (250mg po tiw for BW under 50kg)*12m | Drug | Standard regimen |
| Ethambutol (E)ethambutol 25mg/kg po tiw*6m | Drug | Contezolid shortened regimen |
| Ethambutol (E)ethambutol 25mg/kg po tiw*12m | Drug | Standard regimen |
| Rifampicin (R)rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)*6m | Drug | Contezolid shortened regimen |
| Rifampicin (R)rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)*12m | Drug | Standard regimen |
Primary outcome
culture conversion
Time frame: end of month 6
2 consecutive negative sputum mycobacterial culture at least 4 weeks apart, or one negative bronchoalveolar lavage fluid culture/NGS.
CT lesion absorption
Time frame: end of month 6
>30% decrease in lesion size or number of nodules measured on CT
QOL-B+NTM module
Time frame: end of month 6
Improvement greater than MID in at least 7 out of 12 domains in QOL-B with NTM-module (must include respiratory symptoms and NTM-PD symptoms)
5 secondary outcomes
culture conversion
Time frame: up to month 12
CT lesion status
Time frame: end of month 3, 6, and 12 (for standard regimen)/end of month 3 and 6 (for shortened regimen)
Questionnaire: Quality of life-bronchiectasis (QOL-B) and NTM module
Time frame: up to month 12
SGRQ
Time frame: up to month 12
time to positivity of mycobacterium culture
Time frame: up to month 12
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.
Xiaojin Cui, M.D. principal investigator
China-Japan Friendship Hospital
6 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, Azithromycin and Ethambutol (E) in people with Mycobacterium Avium Complex Pulmonary Disease, run by Bin Cao at 6 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 6 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. (+861084205566, orbitline2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
culture conversion (time frame: end of month 6). The study lists 3 primary outcomes in all. 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.