Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease

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

Interventions

DRUG

Contezolid

contezolid 800mg po q12h\*6m

DRUG

Azithromycin

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

DRUG

Azithromycin

azithromycin 500mg po tiw (250mg po tiw for BW under 50kg)\*12m

DRUG

Ethambutol (E)

ethambutol 25mg/kg po tiw\*6m

DRUG

Ethambutol (E)

ethambutol 25mg/kg po tiw\*12m

DRUG

Rifampicin (R)

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

DRUG

Rifampicin (R)

rifampicin 600mg po tiw (450mg po tiw for BW under 50kg)\*12m

Sponsors & Collaborators

• MicuRx

  collaborator INDUSTRY

• Shanghai Pulmonary Hospital, Shanghai, China

  collaborator OTHER

• Beijing Chest Hospital

  collaborator OTHER

• Anhui Chest Hospital

  collaborator OTHER

• Jiangxi Chest Hospital

  collaborator UNKNOWN

• Guangzhou Chest Hospital.

  collaborator UNKNOWN

• Bin Cao

  lead OTHER

Principal Investigators

• Xiaojin 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

2028-09-30

Completion

2028-12-31

Countries

• China

Study Locations