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A randomized controlled trial examining the efficacy of prophylactic antibiotics for patients with responsible bronchial stenosis

Open-label, randomized, parallel-group comparative study to evaluate the efficacy of antimicrobial therapy for prevention of respiratory tract infections after bronchoscopy in patients with stenosis of responsible bronchus

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061240111
Enrollment
200
Registered
2025-01-20
Start date
2025-01-20
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

Diseases that cause stenosis of the responsible bronchus

Interventions

For 5 days from 4-8 hours after the day of bronchoscopy: potassium clavulanate amoxicillin hydrate 3 for 3, amoxicillin hydrate 3 for 3 orally
if there is moderate renal impairment (eGFR 10-49 mL/min), dose reduced to 2 for 2 tablets each
D000900
antibiotics

Sponsors

Nishioka Yasuhiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged 20 years or older at the time of consent (regardless of gender) 2) Patients with bronchoscopy showing stenosis in the bronchi up to the subareolar bronchus (excluding postoperative changes or physiologic stenosis) 3) Patients who are able to make an outpatient visit to the site after 4 weeks 4) Patients who have been fully informed about their participation in this study, and who have given written consent to participate in the study of their own free will after full understanding of the study

Exclusion criteria

Exclusion criteria: 1) Patients with a history of allergy to penicillin or cephem antibiotics 2) Patients with a history of jaundice or hepatic dysfunction with penicillin antibacterial agents 3) Patients with severe renal dysfunction (eGFR < 10 mL/min) 4) Patients with a body temperature of 37 degrees or higher (axillary temperature) prior to bronchoscopy 5) Patients with a clear active infection prior to bronchoscopy 6) Patients who have received antimicrobial therapy within 1 week of bronchoscopy 7) Patients who are participating or intend to participate in other clinical studies while participating in this study 8) Participation in the research is not in the best interest of the research subject or is deemed to interfere with the evaluation specific to the clinical research protocol 9) Any employee of the Principal Investigator or the site who is directly involved in this or other clinical research, or any family member of such an employee or Principal Investigator

Design outcomes

Primary

MeasureTime frame
Percentage of patients who developed respiratory infections that required antibiotic treatment within 4 weeks

Secondary

MeasureTime frame
1)Proportion of cases requiring a change in lung cancer treatment (postponement, discontinuation, or death) after 28 days of bronchoscopy 2)Proportion of patients who developed respiratory infection after bronchoscopy in the group that received prophylactic antibiotics and the group that did not receive prophylactic antibiotics as scheduled 3)Proportion of respiratory infections after bronchoscopy by degree of stenosis (26-50%, 51-75%, 76-100%) 4)Percentage of patients who received antibiotics due to other factors within 4 weeks of examination and percentage of patients who developed respiratory infections after bronchoscopy when those patients are excluded 5)Number of adverse events due to antibiotics, incidence rate, and nature and severity of such events

Contacts

Public ContactMiyamoto Kenya

Tokushima University Hospital

kenya.miya@tokushima-u.ac.jp+81-88-633-7127

Outcome results

None listed

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