UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008813
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email jnagaoka@juntendo.ac.jp

Sponsor
Institute Respiratory medicine, Juntendo university.
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.