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

Primary Purpose

Fever, Pneumonia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
oral amoxicillin/clavulanate 1g (875/125mg)
control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fever focused on measuring bronchoscopy, post-bronchoscopy fever, pneumonia, cytokines, amoxicillin/clavulanate, prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • concurrent treatment with antibiotics or systemic corticosteroid

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    control

    Amoxicillin/clavulanate

    Arm Description

    control without intervention

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 14, 2010
    Last Updated
    July 19, 2011
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01089218
    Brief Title
    The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines
    Official Title
    The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    February 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Seoul National University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fever, Pneumonia
    Keywords
    bronchoscopy, post-bronchoscopy fever, pneumonia, cytokines, amoxicillin/clavulanate, prophylaxis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    241 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    control without intervention
    Arm Title
    Amoxicillin/clavulanate
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    oral amoxicillin/clavulanate 1g (875/125mg)
    Other Intervention Name(s)
    prophylaxis group
    Intervention Description
    oral amoxicillin/clavulanate 1g (875/125mg) on the day of the procedure 30 minutes prior to the FB
    Intervention Type
    Drug
    Intervention Name(s)
    control
    Intervention Description
    no intervention with the same procedure of FB
    Primary Outcome Measure Information:
    Title
    The incidence of fever
    Description
    time frame for body temperature 24hr before and after bronchoscopy every 4hrs
    Time Frame
    24 hr after bronchoscopy
    Secondary Outcome Measure Information:
    Title
    change of serum cytokines level
    Description
    Time frame for cytokine measurement 24hr before brochoscopy - 1hr after bronchosocpy - 24hr after brochoscopy
    Time Frame
    before bronchoscopy and 24hr after bronchoscopy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adult patients (aged 18 years or older) who underwent FB Exclusion Criteria: concurrent treatment with antibiotics or systemic corticosteroid
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deog Kyeom Kim, MD.
    Organizational Affiliation
    Seoul Metropolitan Government, Seoul National University Boramae Medical Center, 39 Boramae-Gil, Dongjak-Gu, Seoul, Republic of Korea 156-707.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21396214
    Citation
    Park JS, Lee CH, Yim JJ, Yang SC, Yoo CG, Chung HS, Kim YW, Han SK, Shim YS, Kim DK. Impact of antibiotic prophylaxis on postbronchoscopy fever: a randomised controlled study. Int J Tuberc Lung Dis. 2011 Apr;15(4):528-35. doi: 10.5588/ijtld.10.0386.
    Results Reference
    derived

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

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