Short-term bactericidal effect of contezolid for Mycobacterium avium complex lung disease

Short-term Bactericidal Effect of Contezolid in Mycobacterium Avium Complex Pulmonary Disease

This trial tests whether giving adults with MAC pulmonary disease contezolid in addition to the usual antibiotics helps reduce bacteria in sputum and checks for safety.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Capital Medical University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT07084402 on ClinicalTrials.gov

What this trial studies

Adults with confirmed nodular bronchiectatic MAC pulmonary disease will receive either contezolid daily plus the standard regimen of azithromycin, ethambutol and rifampicin (other drugs taken three times weekly) or the standard regimen alone for six months. Participants will visit the clinic about once a month for checkups and sputum tests to measure bacterial load and monitor for side effects. The main goal is to see if adding contezolid produces a greater short-term drop in sputum bacterial counts than the standard regimen alone while documenting adverse events. Eligibility is limited to adults 18–75 years who have not had anti-MAC treatment in the prior three months.

Who should consider this trial

Good fit: Adults aged 18–75 with a confirmed diagnosis of MAC pulmonary disease of the nodular bronchiectatic type who have not received anti-MAC therapy in the prior three months are the intended participants.

Not a fit: People who are pregnant or breastfeeding, outside the 18–75 age range, recently treated for MAC, or unable to attend monthly clinic visits are unlikely to benefit from joining this protocol.

Why it matters

Potential benefit: If effective, adding contezolid could lower bacterial burden faster and potentially improve treatment outcomes for people with MAC pulmonary disease.

How similar studies have performed: Related oxazolidinone antibiotics such as linezolid have shown activity against nontuberculous mycobacteria but clinical experience is limited, making this a relatively novel application of contezolid.

Eligibility criteria

Inclusion Criteria:

1. Patients voluntarily participate in this study and sign the Informed Consent Form.
2. Age ≥ 18 years and ≤75 years; gender unrestricted.
3. 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.
4. No prior anti-MAC treatment within the 3 months preceding screening.
5. 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.

   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.
6. Organ function criteria met within one week prior to enrollment:

i. 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.

x. Fasting blood glucose within normal range OR stable glycemic control in diabetic patients.

xi. Cardiac function: No myocardial infarction in the preceding 6 months; No unstable angina or severe arrhythmias; New York Heart Association (NYHA) functional class \>II.

Exclusion Criteria:

1. History of allergy to any study drug in the treatment regimen.
2. Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses (e.g., HIV coinfection).
3. 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.
4. History of solid organ transplantation.
5. Currently undergoing dialysis.
6. Uncontrolled radiation pneumonitis requiring steroid or immunoglobulin pulse therapy, active interstitial lung disease with clinical evidence, uncontrolled and significant pleural effusion or pericardial effusion.
7. 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).
8. Poor gastrointestinal function or malabsorption syndrome.
9. Receipt of other investigational drugs within 4 weeks prior to the first study drug administration.
10. Concurrent participation in another interventional clinical trial, unless it is an observational/noninterventional study OR follow-up phase of a completed intervention trial.
11. Any physical examination findings or clinical tests deemed by the investigator as likely to:

Interfere with study results; Increase risks of complications during treatment.

Where this trial is running

Beijing, Beijing Municipality and 2 other locations

• Beijing Chest Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Active_not_recruiting)
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Jiangxi Provincial Chest Hospital — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Principal investigator: Xiaojing Cui, M.D. — China-Japan Friendship Hospital
• Study coordinator: Siwei Gu, M.D.

Conditions Mycobacterium Avium Complex Pulmonary Disease