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

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.

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Key information

Conditions

Mycobacterium Abscessus Infection Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Mycobacterium Infections, Nontuberculous NTM Lung Infection Due to MAC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omadacycline Treatment Group

Drug

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Beijing Chest Hospital

Other

Registry information

Official study title

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

Acronym: NTM

Important dates

Study start: 2014
Primary completion: 2029
Study completion: 2029
First posted: May 29, 2026
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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