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Short-term Bactericidal Effect of Contezolid in MAC-PD

NCT07084402 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-09-18

No results posted yet for this study

Summary

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

  • Mycobacterium Avium Complex Pulmonary Disease

Interventions

DRUG

Contezolid

contezolid 800mg po q12h for 6 months

DRUG

Azithromcyin

azithromycin 500mg po tiw (250mg po tiw if weight below 50kg) for 6 months.

DRUG

Rifampicin (RIF)

rifampicin 600mg po tiw for 6 months.

DRUG

Ethambutol

ethambutol 25mg/kg po tiw for 6 months.

Sponsors & Collaborators

  • Beijing Chest Hospital, Capital Medical University

    collaborator OTHER

  • Jiangxi Provincial Chest Hospital

    collaborator UNKNOWN

  • MicuRx

    collaborator INDUSTRY

  • Bin Cao

    lead OTHER

Principal Investigators

  • Xiaojing Cui, M.D. · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2027-07-24
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07084402 on ClinicalTrials.gov