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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07615309
Acronym
NTM
Enrollment
200
Registered
2026-05-29
Start date
2014-01-01
Completion date
2029-12-31
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycobacterium Abscessus Infection, NTM Lung Infection Due to MAC

Keywords

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

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.

Interventions

DRUGOmadacycline 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.

Sponsors

Beijing Chest Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of favorable treatment outcomesFrom January 2014 to December 2029The 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026