nontuberculous mycobacterial pulmonary disease
Conditions
Interventions
None listed
Sponsors
Japanese Red Cross Kyoto Daiichi Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients suspected of having pulmonary nontuberculous mycobacterial disease (NTM-PD) based on clinical findings, including imaging findings such as nodular opacities, branching opacities, diffuse homogeneous opacities, cavitary opacities, or bronchial/bronchiolar dilatation. 2. Patients who are scheduled to undergo bronchoscopy as part of routine clinical care for the diagnosis of NTM-PD, with planned collection of post-bronchoscopy sputum (PBS) and gastric aspirate for culture. 3. Patients aged 20 years or older at the time of enrollment. 4. Patients who are unable to submit sputum for culture before bronchoscopy, or who have not had the same mycobacterial species identified as positive on two or more occasions. 5. Patients from whom written informed consent to participate in this study has been obtained.
Exclusion criteria
Exclusion criteria: 1. Patients who already meet the diagnostic criteria for pulmonary nontuberculous mycobacterial disease (NTM-PD) before bronchoscopy, or who have a history of treatment for NTM-PD. 2. Patients in whom any of the following specimens were not obtained: bronchoscopic specimens, gastric aspirate for culture, or post-bronchoscopy sputum (PBS). 3. Patients in whom diseases other than NTM-PD, such as pulmonary tuberculosis or lung cancer, are strongly suspected based on clinical findings including imaging findings. 4. Patients who are otherwise considered inappropriate for participation in this study by the principal investigator or the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the incremental diagnostic yield of adding gastric aspirate culture and post-bronchoscopy sputum (PBS) to bronchoscopy for the diagnosis of pulmonary nontuberculous mycobacterial disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Microbiological test results for each specimen (bronchoscopic specimens, gastric aspirate, and post-bronchoscopy sputum [PBS]) 2.Time to culture positivity (TTP) for each specimen 3.Proportion and details of additional diagnostic cases newly diagnosed by the addition of PBS and/or gastric aspirate culture 4.Clinical characteristics of additional diagnostic cases 5.Final diagnostic classification (Definite NTM, Probable NTM, Indeterminate, and Not NTM) 6.Frequency and details of adverse events related to bronchoscopy and collection of PBS and gastric aspirate | — |
Countries
Japan
Contacts
Public ContactTatsuya Imabayashi
Japanese Red Cross Kyoto Daiichi Hospital Department of Respiratory Medicine
Outcome results
None listed