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

July 19, 2011 updated by: Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • concurrent treatment with antibiotics or systemic corticosteroid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • prophylaxis group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of fever
Time Frame: 24 hr after bronchoscopy
time frame for body temperature 24hr before and after bronchoscopy every 4hrs
24 hr after bronchoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before bronchoscopy and 24hr after bronchoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

March 14, 2010

First Submitted That Met QC Criteria

March 17, 2010

First Posted (ESTIMATE)

March 18, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • postFB fever

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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