Clinical Study on the Early Bactericidal Activity of Contezolid Against Mycobacterium Abscessus Disease

January 23, 2026 updated by: Nie WenJuan, Beijing Chest Hospital
This study is a single-center, randomized, controlled, open-label clinical trial designed to assess the early bactericidal activity of a single agent, contezolid, in patients with Mycobacterium abscessus infections. Patients were administered contezolid monotherapy for 14 days specifically targeting Mycobacterium abscessus, and were compared to a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug. The comparison was conducted through the analysis of colony forming units counts and Time To Positivity in sputum cultures. By evaluating the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus infections, this study aimed to assess the early bactericidal activity of contezolid, thereby providing a basis for the selection of new therapeutic options for the treatment of patients with Mycobacterium abscessus infections.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

As one of the drugs for treating Mycobacterium abscessus infections, linezolid is effective but its use is limited in anti-Mycobacterium abscessus treatment regimens due to the high incidence of adverse reactions associated with long-term use. Contezolid, a new drug developed in China, belongs to the oxazolidinone class of drugs and shares a similar antibacterial spectrum with linezolid, while exhibiting a significantly better safety profile. This study is a single-center, randomized, controlled, open-label clinical trial designed to evaluate the early bactericidal activity. It enrolls patients with Mycobacterium abscessus disease and administers a 14-day monotherapy of contezolid for the treatment of the disease. The study compares contezolid with linezolid, a classic anti-Mycobacterium abscessus drug, by analyzing colony forming units and Time To Positivity in sputum cultures. By assessing the impact of contezolid monotherapy on the bacterial load in the sputum of patients with Mycobacterium abscessus disease, the study evaluates the early bactericidal activity of contezolid, providing a basis for the selection of new therapeutic options for the treatment of Mycobacterium abscessus disease.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 101149
        • Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female aged between 18 and 65 years old;
  • Weight ranging from 40 kg to 90 kg;
  • At least one positive sputum culture for Mycobacterium abscessus within 6 months prior to screening, and one positive sputum culture for Mycobacterium abscessus with molecular species identification during the screening period within 1 month prior to the study;
  • Voluntary participation in this study and signing of the informed consent form; (5) Male and female participants must use effective contraception during the study and for 1 month after the study ends.

Exclusion Criteria:

  • Patients who have been on long-term corticosteroid therapy or taking immunosuppressants within 90 days prior to screening;
  • Pregnant women, postpartum women, and lactating patients;
  • Patients with a history of bedaquiline allergy or known hypersensitivity, or a history of severe adverse reactions;
  • Patients with evidence of bedaquiline resistance;
  • Patients deemed unsuitable for participation in this study by the investigator's assessment;
  • Patients whom the investigator believes participation in this study would harm their health, or who are unlikely to comply with the scheduled visits and assessments as outlined in the protocol, and therefore are not suitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Contezolid group
Contezolid 800mg twice daily for 14 days. To enroll 12 patients with Mycobacterium abscessus infections, who will receive continuous administration of contezolid for 14 days. Sputum samples will be collected for colony forming units counting and Time To Positivity observation to evaluate the Early Bactericidal Activity.
Drug: Contezolid
Patients with Mycobacterium abscessus infections were enrolled and treated with a 14-day monotherapy of contezolid for anti-Mycobacterium abscessus therapy, through analysis and comparison of colony forming units and Time To Positivity in sputum cultures.
Other Names:
  • Oxazolidinone
Active Comparator: Linezolid group
Linezolid 600mg once daily for 14 days. To enroll 12 patients with Mycobacterium abscessus infections, who will receive continuous administration of linezolid for 14 days. Sputum samples will be collected for colony forming units counting and Time To Positivity observation to evaluate the Early Bactericidal Activity.
Drug: linezolid
Patients with Mycobacterium abscessus infections were enrolled and treated with a 14-day monotherapy of linezolid for anti-Mycobacterium abscessus therapy, through analysis and comparison of colony forming units and Time To Positivity in sputum cultures.
Other Names:
  • Oxazolidinone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time To Positivity in sputum cultures
Time Frame: 14 days
With a 14-day monotherapy of contezolid for anti-Mycobacterium abscessus therapy, then were compared with a control group receiving linezolid, a classic anti-Mycobacterium abscessus drug, through analysis and comparison of Time To Positivity in sputum cultures.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chest Hospital

Investigators

  • Study Director: Wenjuan Nie, Director, Beijing Tuberculosis & Thoracic Tumor Research Institute Beijing Chest Hospital affiliated to Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCP-TB-2024-11-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In our hospital, the investigators are not allowed to casually publish participants' information and hospital data on the website.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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