NCT01089218

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2010

Completed
Last Updated

July 21, 2011

Status Verified

July 1, 2011

Enrollment Period

9 months

First QC Date

March 14, 2010

Last Update Submit

July 19, 2011

Conditions

FeverPneumonia

Keywords

bronchoscopypost-bronchoscopy feverpneumoniacytokinesamoxicillin/clavulanateprophylaxis

Outcome Measures

Primary Outcomes (1)

  • The incidence of fever

    time frame for body temperature 24hr before and after bronchoscopy every 4hrs

    24 hr after bronchoscopy

Secondary Outcomes (1)

  • change of serum cytokines level

    before bronchoscopy and 24hr after bronchoscopy

Study Arms (2)

control

NO INTERVENTION

control without intervention

Drug: control

Amoxicillin/clavulanate

ACTIVE COMPARATOR
Drug: oral amoxicillin/clavulanate 1g (875/125mg)

Interventions

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

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

Also known as: prophylaxis group
Amoxicillin/clavulanate
controlDRUG

no intervention with the same procedure of FB

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • concurrent treatment with antibiotics or systemic corticosteroid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21396214DERIVED

MeSH Terms

Conditions

FeverPneumonia

Interventions

AmoxicillinClavulanic Acid

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsClavulanic Acids

Study Officials

  • Deog Kyeom Kim, MD.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2010

First Posted

March 18, 2010

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

February 1, 2010

Last Updated

July 21, 2011

Record last verified: 2011-07