UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008813 |
|---|---|
| Receipt number | R000010358 |
| Scientific Title | Efficacy of antibiotic prophylaxis on postbronchoscopy fever after endobronchial ultrasound-guided transbronchial needle biopsy |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2020/06/08 09:50:59 |
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Basic information
Public title
Efficacy of antibiotic prophylaxis on postbronchoscopy fever after
endobronchial ultrasound-guided transbronchial needle biopsy
Acronym
Antibiotic prophylaxis after EBUS-TBNA
Scientific Title
Efficacy of antibiotic prophylaxis on postbronchoscopy fever after
endobronchial ultrasound-guided transbronchial needle biopsy
Scientific Title:Acronym
Antibiotic prophylaxis after EBUS-TBNA
Region
| Japan |
Condition
Condition
primary lung cancer, sarcoidosis, malignant lymphoma, metastatic lung tumor,mediastinal tumor, etc.
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of prophylactic antibiotics to prevent the postbronchoscopy fever after EBUS-TBNA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body temperature within 5 days after EBUS-TBNA.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
AMPC/CVA+ABPC/SBT.
Interventions/Control_2
Control.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients more than 20 years old when EBUS-TBNA is performed.
(2)Patients who do not have fever, infection when EBUS-TBNA is performed.
Key exclusion criteria
(1)Patients who have the infection when EBUS-TBNA is performed.
(2)Patients with treatment of steroid when EBUS-TBNA is performed.
(3)Patients with treatment of another antibiotics when EBUS-TBNA is performed.
(4)Patients with a history of hypersensitivity to penicillin antibiotics.
(5)Patients with acitive infectious mononucleosis.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsutaro Nagaoka |
Organization
Juntendo university.
Division name
Respiratory medicine.
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nagaoka Tetsutaro |
Organization
Juntendo university.
Division name
Respiratory medicine.
Zip code
Address
TEL
Homepage URL
jnagaoka@juntendo.ac.jp
Sponsor or person
Institute
Respiratory medicine, Juntendo university.
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 30 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010358
