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NCT01089218 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01089218
Other study ID # postFB fever
Secondary ID
Status Completed
Phase Phase 4
First received March 14, 2010
Last updated July 19, 2011
Start date April 2008
Est. completion date February 2010

Study information
Verified date July 2011
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 241
Est. completion date February 2010
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- concurrent treatment with antibiotics or systemic corticosteroid

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• oral amoxicillin/clavulanate 1g (875/125mg)
oral amoxicillin/clavulanate 1g (875/125mg) on the day of the procedure 30 minutes prior to the FB
• control
no intervention with the same procedure of FB

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of fever time frame for body temperature 24hr before and after bronchoscopy every 4hrs 24 hr after bronchoscopy Yes
Secondary change of serum cytokines level Time frame for cytokine measurement 24hr before brochoscopy - 1hr after bronchosocpy - 24hr after brochoscopy before bronchoscopy and 24hr after bronchoscopy Yes
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