Lung Cancer Lung Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. patients scheduled for bronchoscopy for suspected malignancy who have any of the following risk factors (1-4) for developing infection after bronchoscopy 1) Chest CT within 1 month prior to the examination showing a cavity in the lesion. 2) Low-absorption area in the lesion on chest CT within 1 month prior to the examination 3) Obvious obstruction or stenosis in the responsible bronchus reaching the lesion on chest CT within 1 month prior to the examination The above CT findings should be determined by pre-examination reading of a chest CT (CT with slice thickness of 1.0 mm or less) within 1 month prior to the examination by at least 2 respiratory physicians 2. patients with PS2 or less 3. patients who are 20 years of age or older at the time consent is obtained 4. patients who have given a full explanation of their participation in this study, and who have given written consent of their own free will based on full understanding.
Exclusion criteria
Exclusion criteria: 1. history of hypersensitivity to beta-lactam antibacterial agents 2. women who are pregnant or may be pregnant 3. coexisting infection or receiving an antimicrobial agent other than those specified in this study within 1 week prior to testing 4. concomitant overt immunodeficiency disease or receiving systemic steroids at a prednisone equivalent of 20 mg/day or more 5. poorly controlled diabetes mellitus 6. serious hepatic or renal disorder 7. other conditions for which the principal investigator or subinvestigator determines the patient to be ineligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of infection within 2 weeks after bronchoscopy Infection is considered to be present when all of the following are met. Onset or worsening of fever and respiratory symptoms greater than 37.5 Elevated white blood cell count or CRP level compared to pre-test Newly developed or worsening infiltrate shadow on chest radiograph or chest CT | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical background factors, blood tests (hematology, biochemistry) prior to bronchoscopy, CT imaging findings, relationship between bronchoscopic findings and concurrent infection, results of bacterial and acid-fast smear cultures of bronchial lavage fluid, Bronchoscopy diagnostic rate Bronchoscopy date to end of observation: evaluate these items in approximately 2 weeks. | — |
Contacts
Fujita Health University Hospital