Shortened contezolid-enhanced treatment for Mycobacterium avium complex lung disease

Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease

This study will try adding contezolid to standard antibiotics to see if adults with Mycobacterium avium complex lung disease can have lower bacterial counts, less lung damage, and better quality of life with a 6-month treatment.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Capital Medical University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 6 sites (Hefei, Anhui and 5 other locations)
• Trial ID: NCT07213765 on ClinicalTrials.gov

What this trial studies

Adults with the nodular bronchiectatic form of MAC pulmonary disease will receive either contezolid plus the standard regimen (azithromycin, ethambutol, rifampicin) or the standard regimen alone for six months, with contezolid given daily and the other drugs taken three times weekly. Researchers will compare changes in bacterial load, radiographic lesion severity, and patient-reported quality of life between the two groups. Safety monitoring will focus on adverse events related to extended contezolid use. The trial aims to determine whether adding contezolid can shorten effective therapy while maintaining or improving tolerability.

Who should consider this trial

Good fit: Adults aged 18–75 with confirmed nodular bronchiectatic Mycobacterium avium complex pulmonary disease who have not received anti‑MAC therapy in the prior 3 months and who can comply with contraception and study visits are ideal candidates.

Not a fit: Patients outside the age range, those with other clinical forms of MAC disease, recent anti‑MAC treatment, pregnancy or breastfeeding, or inability to attend study sites in China are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding contezolid could shorten treatment duration while reducing bacterial burden and lung lesions and improving patients' quality of life.

How similar studies have performed: Oxazolidinone antibiotics such as linezolid have activity against nontuberculous mycobacteria but are limited by toxicity, and contezolid is a newer agent with some favorable safety data yet limited clinical evidence specifically for MAC pulmonary disease.

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

Hefei, Anhui and 5 other locations

• Anhui Chest Hospital — Hefei, Anhui, China (RECRUITING)
• Beijing Chest Hospital, Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Guangzhou Chest Hospital — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Jiangxi Chest Hospital — Nanchang, Jiangxi, China (RECRUITING)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)

Study contacts

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

Conditions: Mycobacterium Avium Complex Pulmonary Disease, non-tuberculous mycobacterium, contezolid