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

NCT07615309 | Enrolling By Invitation

• 1 other identifier: GCP-NTM-26616
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mycobacterium Abscessus Infection; NTM Lung Infection Due to MAC

Keywords

Omadacycline; Mycobacterium abscessus; Nontuberculous mycobacterial disease; Treatment outcome; Retrospective study

Outcome Measures

Primary Outcomes (1)

• Rate of favorable treatment outcomes

  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

Study Arms (1)

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

Interventions

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.

Omadacycline Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Chest Hospital: lead

Study Sites (1)

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

Beijing, China

Location

MeSH Terms

Conditions

Mycobacterium Infections, Nontuberculous

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: May 29, 2026
• Study Start: January 1, 2014
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)