Actively Recruiting
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Led by Bin Cao · Updated on 2025-10-09
188
Participants Needed
6
Research Sites
179 weeks
Total Duration
On this page
Sponsors
B
Bin Cao
Lead Sponsor
M
MicuRx
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily agree to participate and sign consent
- Age between 18 and 75 years, any gender
- Confirmed diagnosis of MAC pulmonary disease with nodular bronchiectatic features per guidelines
- No anti-MAC treatment within 3 months before screening
- Premenopausal women not surgically sterile must use effective contraception during study and for 3 months after
- Negative pregnancy test within 72 hours before enrollment for applicable women
- Must not be breastfeeding
- Male participants with partners of childbearing potential must use contraception during study and 3 months after
- Meet organ function criteria within 1 week before enrollment including hemoglobin, neutrophils, platelets, liver and kidney function, blood glucose, and cardiac health
You will not qualify if you...
- Allergy to any study drug
- Mixed infections with multiple mycobacteria, bacteria, fungi, or viruses including HIV
- Immunodeficiency disorders, active pulmonary or other malignancies requiring treatment
- History of solid organ transplant
- Currently on dialysis
- Uncontrolled lung conditions like radiation pneumonitis or interstitial lung disease
- Significant unstable systemic illnesses including severe heart, psychiatric, liver, kidney, or neurodegenerative diseases
- Poor gastrointestinal function or malabsorption syndrome
- Use of other investigational drugs within 4 weeks prior to study drug
- Participation in other interventional clinical trials unless observational or follow-up phase
- Any clinical findings that may interfere with study results or increase treatment risks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Anhui Chest Hospital
Hefei, Anhui, China
Actively Recruiting
2
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
3
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
Guangzhou Chest Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
5
Jiangxi Chest Hospital
Nanchang, Jiangxi, China
Actively Recruiting
6
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
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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