Mycobacterium Abscessus InfectionNTMNCT07615309
To Evaluate the Clinical Efficacy and Safety of Omadacycline in the Treatment of Mycobacterium Abscessus Infection.
An observational study of Mycobacterium Abscessus Infection and NTM Lung Infection Due to MAC, run by Beijing Chest Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Abscessus Infection, NTM Lung Infection Due to MAC
- What is being tested?
- Omadacycline Treatment Group
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Co-infection with other non-tuberculous mycobacterial species;
- Treatment duration less than 1 month;
- Missing key clinical data required for outcome assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis&Thoracic Tumor Research Institute, Beijing, BEIJING 101149
Beijing
About this study
Official title: 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.
- Being tested
- Omadacycline Treatment Group
- Keywords
- Omadacycline, Mycobacterium abscessus, Nontuberculous mycobacterial disease, Treatment outcome, Retrospective study
- Medical subject headings
- Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omadacycline Treatment GroupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Omadacycline Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From January 2014 to December 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jan 2014
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Abscessus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nie WenJuan, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615309
- Sponsor's protocol ID
- GCP-NTM-26616
- Acronym
- NTM
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In our hospital, researchers are not allowed to upload patient data or hospital information to websites without authorization.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Prognostic Analysis of Omadacycline in the Treatment of Mycobacterium Abscessus Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT07615309
- Acronym / sponsor ID
- NTM / GCP-NTM-26616
- Keywords
- Omadacycline, Mycobacterium abscessus, Nontuberculous mycobacterial disease, Treatment outcome, Retrospective study
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omadacycline Treatment Group | – | Drug: Omadacycline Treatment GroupAccording 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Co-infection with other non-tuberculous mycobacterial species;
- Treatment duration less than 1 month;
- Missing key clinical data required for outcome assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omadacycline Treatment GroupPatients 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 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No. In our hospital, researchers are not allowed to upload patient data or hospital information to websites without authorization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycobacterium Abscessus Infection and NTM Lung Infection Due to MAC, run by Beijing Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of favorable treatment outcomes (time frame: From January 2014 to December 2029). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.