The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines

Phase 4

Completed

• Conditions: Fever; Pneumonia
• Interventions: Drug: oral amoxicillin/clavulanate 1g (875/125mg); Drug: control

• Registration Number: NCT01089218
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Fever can develop after fiberoptic bronchoscopy (FB) in about 2.5 - 16 % of adult patients. We evaluated the impact of oral amoxicillin/clavulanate (AC) on incidence of postbronchoscopic fever and pneumonia.

Detailed Description

For the population being undergone with bronchoscopy, the clinical signs and procedural measures for complication of bronchoscopy and cytokines will be checked.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-01
• Study Completion: 2010-02
• Study First Submitted: 2010-03-14
• Study First Submitted QC: 2010-03-17
• Study First Posted: 2010-03-18
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

• adult patients (aged 18 years or older) who underwent FB

Exclusion Criteria

• concurrent treatment with antibiotics or systemic corticosteroid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amoxicillin/clavulanate	oral amoxicillin/clavulanate 1g (875/125mg)	-
control	control	control without intervention

Primary Outcome Measures

Name	Time	Method
The incidence of fever	24 hr after bronchoscopy	time frame for body temperature 24hr before and after bronchoscopy every 4hrs

Secondary Outcome Measures

Name	Time	Method
change of serum cytokines level	before bronchoscopy and 24hr after bronchoscopy	Time frame for cytokine measurement 24hr before brochoscopy - 1hr after bronchosocpy - 24hr after brochoscopy