Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease

NCT07213765 | Recruiting Phase 4

• 1 other identifier: 2025-KY-004
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Mycobacterium Avium Complex Pulmonary Disease

Keywords

Mycobacterium Avium Complex Pulmonary Disease; non-tuberculous mycobacterium; contezolid

Outcome Measures

Primary Outcomes (3)

• culture conversion

  2 consecutive negative sputum mycobacterial culture at least 4 weeks apart, or one negative bronchoalveolar lavage fluid culture/NGS.

  end of month 6

• CT lesion absorption

  \>30% decrease in lesion size or number of nodules measured on CT

  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)

  end of month 6

Secondary Outcomes (5)

• culture conversion

  up to month 12

• CT lesion status

  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

  up to month 12

• SGRQ

  up to month 12

• time to positivity of mycobacterium culture

  up to month 12

Other Outcomes (3)

• Number of participants with adverse events

  up to month 12

• MAC strain drug-sensitivity

  end of month 6 (for shortened regimen)/end of month 12 (for standard regimen)

• Number of participants with treatment-related abnormal laboratory tests results

  up to month 12

Study Arms (2)

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)

Interventions

Contezolid DRUG

contezolid 800mg po q12h\*6m

Contezolid shortened regimen

Azithromycin DRUG

azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*6m

Contezolid shortened regimen

Ethambutol (E) DRUG

ethambutol 25mg/kg po tiw\*6m

Contezolid shortened regimen

Rifampicin (R) DRUG

rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*6m

Contezolid shortened regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Bin Cao: lead
• MicuRx: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Beijing Chest Hospital: collaborator
• Anhui Chest Hospital: collaborator
• Jiangxi Chest Hospital: collaborator
• Guangzhou Chest Hospital.: collaborator

Study Sites (6)

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

MeSH Terms

Interventions

contezolid; Azithromycin; Ethambutol; Rifampin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ethylenediamines; Diamines; Polyamines; Amines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Xiaojin Cui, M.D.

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siwei Gu, M.D.

CONTACT

+861084205566; orbitline2@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: October 9, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)