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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01089218
First received: March 14, 2010
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Fever
Pneumonia
 Drug: oral amoxicillin/clavulanate 1g (875/125mg)
Drug: control
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The incidence of fever [ Time Frame: 24 hr after bronchoscopy ] [ Designated as safety issue: Yes ]
    time frame for body temperature 24hr before and after bronchoscopy every 4hrs


Secondary Outcome Measures:
  • change of serum cytokines level [ Time Frame: before bronchoscopy and 24hr after bronchoscopy ] [ Designated as safety issue: Yes ]
    Time frame for cytokine measurement 24hr before brochoscopy - 1hr after bronchosocpy - 24hr after brochoscopy


Enrollment: 241
Study Start Date: April 2008
Study Completion Date: February 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
control without intervention
 Drug: control
no intervention with the same procedure of FB
Other Name: control
Active Comparator: Amoxicillin/clavulanate 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
Other Name: prophylaxis group

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • concurrent treatment with antibiotics or systemic corticosteroid
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089218

Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Deog Kyeom Kim, MD. Seoul Metropolitan Government, Seoul National University Boramae Medical Center, 39 Boramae-Gil, Dongjak-Gu, Seoul, Republic of Korea 156-707.
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Deog Kyeom Kim, MD, Seoul Metropolitan Government, Seoul National University Boramae Medical Center
ClinicalTrials.gov Identifier: NCT01089218     History of Changes
Other Study ID Numbers: postFB fever
Study First Received: March 14, 2010
Last Updated: July 19, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
bronchoscopy
post-bronchoscopy fever
pneumonia
 cytokines
amoxicillin/clavulanate
prophylaxis

Additional relevant MeSH terms:
Fever
Pneumonia
Body Temperature Changes
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Anti-Bacterial Agents
 Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013