To Evaluate the Clinical Efficacy and Safety of Omadacycline in the Treatment of Mycobacterium Abscessus Infection. (NTM)

May 23, 2026 updated by: Nie WenJuan, Beijing Chest Hospital

Clinical Efficacy and Prognostic Analysis of Omadacycline in the Treatment of Mycobacterium Abscessus Pulmonary Disease.

The objective of this clinical trial is to evaluate the correlation between clinical efficacy and safety of omadacycline in the treatment of Mycobacterium abscessus infection through retrospective cohort studies. The main questions it aims to answer include: Clinical efficacy of omadacycline in populations stratified by clinical characteristics including age, gender, comorbid immune diseases, albumin level, white blood cell count and pulmonary cavity manifestations on CT.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

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

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

Sampling Method

Probability Sample

Study Population

This study is a unicentral, retrospective clinical study conducted from January 2014 to December 2026 at Beijing Chest Hospital Affiliated to Capital Medical University. Mycobacterium abscessus pulmonary disease patients were receiving Omadacycline treatment. All participants were confirmed by bacteriological culture or molecular biology testing and had complete clinical records with at least 1 month of treatment.

Description

Inclusion Criteria:

  • Diagnosis of Mycobacterium abscessus pulmonary disease confirmed by bacteriological culture or molecular biology testing;
  • Age 18 years or older at the time of diagnosis;
  • Complete clinical records available for review;
  • Treatment duration of at least 1 month.

Exclusion Criteria:

  • Co-infection with other non-tuberculous mycobacterial species;
  • Treatment duration less than 1 month;
  • Missing key clinical data required for outcome assessment.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Omadacycline Treatment Group
According to the patient's group of omadacycline drugs used, record patients with Mycobacterium abscessus pulmonary disease who received omadacycline as part of their treatment regimen.All patients had culture or molecular biology confirmed Mycobacterium abscessus pulmonary disease, were aged 18 years old, had complete clinical records, and treatment duration of at least 1 month.
Drug: Omadacycline Treatment Group
Patients with Mycobacterium abscessus pulmonary disease who received omadacycline as part of their treatment regimen.All patients had culture or molecular biology confirmed Mycobacterium abscessus pulmonary disease, were aged 18 years old, had complete clinical records, and treatment duration of at least 1 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of favorable treatment outcomes
Time Frame: From January 2014 to December 2029
The proportion of participants achieving favorable treatment outcomes, defined as cure plus treatment completion, assessed at the end of anti-mycobacterial therapy. Cure is defined as completion of treatment with multiple consecutive negative cultures and sustained clinical improvement. Treatment completion is defined as sustained clinical improvement without proof of culture conversion due to unavailable specimens.
From January 2014 to December 2029

Collaborators and Investigators

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

Sponsor

Beijing Chest Hospital

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, 2014

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

May 23, 2026

First Submitted That Met QC Criteria

May 23, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 23, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCP-NTM-26616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In our hospital, researchers are not allowed to upload patient data or hospital information to websites without authorization.

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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