CClinicalTrials.gg
Enrolling by invitationNCT07615309NTMUpdated May 29, 2026

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

An observational study in Mycobacterium Abscessus Infection and NTM Lung Infection Due to MAC, sponsored by Beijing Chest Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Beijing Chest Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Mycobacterium Abscessus Infection
  • NTM Lung Infection Due to MAC

Keywords

  • Omadacycline
  • Mycobacterium abscessus
  • Nontuberculous mycobacterial disease
  • Treatment outcome
  • Retrospective study
03

In context

Mycobacterium Infections, Nontuberculous

48 studies on the registry are indexed under Mycobacterium Infections, Nontuberculous; 18 are open to participants now.

This study's planned enrollment of 200 is above the median of 175 across 16 observational studies indexed under Mycobacterium Infections, Nontuberculous.

Browse Mycobacterium Infections, Nontuberculous studies →

Lead sponsor

Beijing Chest Hospital is the lead sponsor of 31 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Co-infection with other non-tuberculous mycobacterial species;
  • Treatment duration less than 1 month;
  • Missing key clinical data required for outcome assessment.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

06

What researchers measure

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.

    Time frame: From January 2014 to December 2029

07

Study locations

1 site
  • Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis&Thoracic Tumor Research Institute, Beijing, BEIJING 101149
    Beijing, China
08

References and documents

Individual participant data

Plan to share: No — In our hospital, researchers are not allowed to upload patient data or hospital information to websites without authorization.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07615309
Lead sponsor
Beijing Chest Hospital
Responsible party
Nie WenJuan (chief physician, Beijing Chest Hospital) — Principal investigator
First posted
May 29, 2026
Start date
Jan 1, 2014
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
May 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion