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Short-term Bactericidal Effect of Contezolid in MAC-PD

ConditionMycobacterium Avium Complex Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBin Cao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Contezolid

    Drug

    contezolid 800mg po q12h for 6 months

  • Azithromcyin

    Drug

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

  • Rifampicin (RIF)

    Drug

    rifampicin 600mg po tiw for 6 months.

  • Ethambutol

    Drug

    ethambutol 25mg/kg po tiw for 6 months.

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: Contezolid plus standard regimenExperimental treatment 4 interventions
Group B: Standard regimenActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

time-to-positivity of sputum mycobacterium culture

Time frame
the end of month 3

Secondary outcomes

1

culture conversion

Time frame
at the end of month 3 and 6
2

time to first culture conversion

Time frame
from enrollment to the end of month 6
3

CT status of the lesion

Time frame
at the end of month 3 and 6
4

adverse events

Time frame
from enrollment to the end of month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bin Cao

Lead sponsor

Capital Medical University

Sponsor institution

Beijing Chest Hospital, Capital Medical University

Collaborator

Jiangxi Provincial Chest Hospital

Collaborator

MicuRx

Collaborator

Source ClinicalTrials.gov
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