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Significance of Prophylactic Antimicrobial Administration for Bronchoscopy

Prophylactic Antimicrobial Administration for Post-Bronchoscopic Transbronchial Biopsy Infection

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041250094
Enrollment
85
Registered
2025-09-08
Start date
2025-09-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer Lung Cancer

Interventions

Administer antimicrobial prophylaxis prior to bronchoscopy.

Sponsors

Imaizumi Kazuyoshi
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Public ContactMasashi Kondo

Fujita Health University Hospital

mkond@fujita-hu.ac.jp+81-562-93-9241

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026