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

JRCT ID: jRCTs061240111

Registered date:20/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Diseases that cause stenosis of the responsible bronchus
• Date of first enrollment: 20/01/2025
• Target sample size: 200
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

• Primary Outcome: Percentage of patients who developed respiratory infections that required antibiotic treatment within 4 weeks

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

1) Patients with a history of allergy to penicillin or cephem antibiotics
2) Patients with a body temperature of 37 degrees or higher (axillary temperature) prior to bronchoscopy
3) Patients with a clear active infection prior to bronchoscopy
4) Patients who have received antimicrobial therapy within 1 week of bronchoscopy
5) Patients with severe renal dysfunction (eGFR < 10 mL/min)
6) Other patients who are judged by the principal investigator or subinvestigators to be inappropriate as research subjects (subjects)

Related Information

• Primary Sponsor: Nishioka Yasuhiko