Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT07084402

Short-term Bactericidal Effect of Contezolid in MAC-PD

Led by Bin Cao · Updated on 2025-09-18

188

Participants Needed

3

Research Sites

127 weeks

Total Duration

On this page

Sponsors

B

Bin Cao

Lead Sponsor

B

Beijing Chest Hospital, Capital Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Short-term Bactericidal Effect of Contezolid in MAC-PD

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients voluntarily agree to participate and sign informed consent.
  • Age between 18 and 75 years, any gender.
  • Confirmed diagnosis of MAC pulmonary disease with nodular bronchiectatic imaging features according to guidelines.
  • No anti-MAC treatment within 3 months before screening.
  • Premenopausal women not surgically sterile must use contraception during and 3 months after treatment, have a negative pregnancy test within 72 hours before enrollment, and not be breastfeeding.
  • Male patients with partners of childbearing potential must use effective contraception during and 3 months after treatment.
  • Meet organ function criteria within 1 week before enrollment, including specified blood counts, liver and kidney function, cardiac function, and stable blood glucose control.
Not Eligible

You will not qualify if you...

  • Allergy to any study drugs.
  • Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses including HIV.
  • Congenital or acquired immunodeficiency, active pulmonary or other malignancies requiring treatment.
  • History of solid organ transplantation.
  • Currently on dialysis.
  • Uncontrolled radiation pneumonitis, active interstitial lung disease, or significant pleural/pericardial effusion.
  • Unstable serious systemic conditions including hypertensive crisis, unstable angina, severe heart failure, recent myocardial infarction, severe psychiatric disorders, severe liver or kidney dysfunction, or neurodegenerative diseases.
  • Poor gastrointestinal function or malabsorption.
  • Use of other investigational drugs within 4 weeks before study drug.
  • Participation in another interventional trial unless observational or follow-up phase.
  • Any clinical findings likely to interfere with study results or increase treatment risk as judged by the investigator.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Active, Not Recruiting

2

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

3

Jiangxi Provincial Chest Hospital

Nanchang, Jiangxi, China

Actively Recruiting

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Research Team

S

Siwei Gu, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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