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

NCT ID: NCT01089218

Last Updated: 2011-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-02-28

Brief Summary

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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

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

Conditions

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Fever Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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control

control without intervention

Group Type NO_INTERVENTION

control

Intervention Type DRUG

no intervention with the same procedure of FB

Amoxicillin/clavulanate

Group Type ACTIVE_COMPARATOR

oral amoxicillin/clavulanate 1g (875/125mg)

Intervention Type DRUG

oral amoxicillin/clavulanate 1g (875/125mg) on the day of the procedure 30 minutes prior to the FB

Interventions

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oral amoxicillin/clavulanate 1g (875/125mg)

oral amoxicillin/clavulanate 1g (875/125mg) on the day of the procedure 30 minutes prior to the FB

Intervention Type DRUG

control

no intervention with the same procedure of FB

Intervention Type DRUG

Other Intervention Names

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prophylaxis group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* concurrent treatment with antibiotics or systemic corticosteroid
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul Metropolitan Government, Seoul National University Boramae Medical Center

Principal Investigators

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Deog Kyeom Kim, MD.

Role: STUDY_DIRECTOR

Seoul Metropolitan Government, Seoul National University Boramae Medical Center, 39 Boramae-Gil, Dongjak-Gu, Seoul, Republic of Korea 156-707.

References

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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.

Reference Type DERIVED
PMID: 21396214 (View on PubMed)

Other Identifiers

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postFB fever

Identifier Type: -

Identifier Source: org_study_id

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