UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002443 |
|---|---|
| Receipt number | 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 00:51:40 |
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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
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
saka@nagoya.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002987
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
