To Evaluate the Clinical Efficacy and Safety of Omadacycline in the Treatment of Mycobacterium Abscessus Infection.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omadacycline Treatment Group.
- Who it may be relevant to
- Registry conditions: Mycobacterium Abscessus Infection, NTM Lung Infection Due to MAC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Efficacy and Prognostic Analysis of Omadacycline in the Treatment of Mycobacterium Abscessus Pulmonary Disease.
Overview
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
- Drug Omadacycline 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.
Primary outcome measures
- Rate of favorable treatment outcomes [Time frame: From January 2014 to December 2029]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis&Thor — Beijing
Identifiers
NCT: NCT07615309 · GCP-NTM-26616