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


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 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


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

Value
https://center6.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