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

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ClinicalTrials.gov Identifier: NCT01089218
Recruitment Status : Completed
First Posted : March 18, 2010
Last Update Posted : July 21, 2011
Sponsor:
Information provided by:

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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines
Study Start Date : April 2008
Primary Completion Date : January 2009
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Pneumonia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: control
control without intervention
Drug: control
no intervention with the same procedure of FB
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


Outcome Measures

Primary Outcome Measures :
  1. The incidence of fever [ Time Frame: 24 hr after bronchoscopy ]
    time frame for body temperature 24hr before and after bronchoscopy every 4hrs


Secondary Outcome Measures :
  1. change of serum cytokines level [ Time Frame: before bronchoscopy and 24hr after bronchoscopy ]
    Time frame for cytokine measurement 24hr before brochoscopy - 1hr after bronchosocpy - 24hr after brochoscopy


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 18, 2010    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

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

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