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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002443
Receipt No. R000002987
Scientific Title Is prophylactic use of antimicrobial agent effective in prevention of infectious complication after diagnostic bronchoscopy?
Date of disclosure of the study information 2009/09/04
Last modified on 2014/09/04

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Basic information
Public title Is prophylactic use of antimicrobial agent effective in prevention of infectious complication after diagnostic bronchoscopy?
Acronym J-BRONCHO
Scientific Title Is prophylactic use of antimicrobial agent effective in prevention of infectious complication after diagnostic bronchoscopy?
Scientific Title:Acronym J-BRONCHO
Region
Japan

Condition
Condition Diseases with the indication of bronchoscopic examination
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the risk of infectious complications in estimating relative risk comparing whether or not in prophylactic use of antimicrobial agent by a prospective cohort survey
Basic objectives2 Others
Basic objectives -Others To estimate the rate of infectious complications
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Whether or not an antimicrobial agent was administered to the patients with infectious complications within one week after bronchoscopic examination
Key secondary outcomes Whether of not any respiratory symptom, disturbance on the daily life, any consultation to the medical facility was recorded, and the maximum body temperature

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with indications for bronchoscopic examination
2) Ages equal or over 20 years old
3) Written informed consent from the patient
Key exclusion criteria 1) Administration of antimicrobial agent within 7 days before examination
2) Therapeitic bronchoscopy
3) Diagnostic bronchoscopy for the confirmation of infectious disease
4) Rigid bronchoscopy
5) On-respirator, general surgery, toracheotomy, bronchoscopic examinations, bronshoscopic treatment within 1 week
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HIDEO SAKA
Organization National Hospital Organization, Nagoya Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya
TEL +81-52-951-1111
Email saka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name HIDEO SAKA
Organization National Hospital Organization, Nagoya Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 4-1-1 Sannomaru, Naka-ku, Nagoya
TEL +81-52-951-1111
Homepage URL
Email saka@nagoya.hosp.go.jp

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立病院機構名古屋医療センター他,59施設

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 04 Day

Related information
URL releasing protocol http://www.csecr.jp/broncho.html
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2007 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2007 Year 09 Month 01 Day
Last follow-up date
2009 Year 04 Month 01 Day
Date of closure to data entry
2009 Year 07 Month 01 Day
Date trial data considered complete
2009 Year 07 Month 01 Day
Date analysis concluded
2009 Year 11 Month 01 Day

Other
Other related information A total of 5,213 cases entered

Management information
Registered date
2009 Year 09 Month 03 Day
Last modified on
2014 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002987

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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