UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Garenoxacin to fever and pro-inflamatory cytokine with bronchoscopy
Acronym	Effect of Garenoxacin to fever and pro-inflamatory cytokine with bronchoscopy
Scientific Title	Effect of Garenoxacin to fever and pro-inflamatory cytokine with bronchoscopy
Scientific Title:Acronym	Effect of Garenoxacin to fever and pro-inflamatory cytokine with bronchoscopy
Region	Japan

Condition
Condition	fever and increase of pro-inflamatory cytokine with bronchoalveolar lavage
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	confirmation of anti-inflamatory effect of garenoxacin It is known that post bronchoalveolar lavage patients often fever up. Recent study shows that bronchoalveolar lavage increases serum pro-inflammatory cytokine. And otherwise, fluoroquinolones like ciprofloxaxin inhibit the inflammatory cells producing cytokines and then fluoroquinolones have an anti-inflammatory effct besides the anti-biotic effect. Garenoxacin a new quinolone developed recently and widely used but its immunomodulatory effect is not confirmed. This study is heading for assessing the effect of garenoxacin to fever and/or inflamtory cytokine with bronchoalveolar lavage.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pro-inflamatory cytokine(IL-1, IL-2, IL-6, IL-10), procalcitonin
Key secondary outcomes	fever, leukocytosis, CRP

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	administration of garenoxacin 200mg per oral 1 hour before the bronchoscopy
Interventions/Control_2	no administration
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	adults agree with the enrolement of study who needs bronchoalveolar lavage to diagnose diffuse lung disease
Key exclusion criteria	(1) patient who has history of hypersensitivity reaction or adverse event to quinolones (2) patients who can't be performed bronchoscopy because of respirotry disorder (3) patient who has disability of oral administration (4) patient who has history of convulsion or epilepsy or who has regular administration of anti- epileptic medicine (5) patients who has autoimmune disease or immuno-disorders (6) patients who has administration of systemic corticosteroid (7) patients who are administerd antibiotics within 2 weeks (8) pregnanct or possibility of pregnant or breast feeding (9) patients not suitable to administration of garenoxacin considered by attending physician (10) patients who has possibility of negative impact to diagnosis by administration of garenoxacin
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Hasegawa
Organization	Keio University Hospital
Division name	Infection control center
Zip code
Address	35 Shinanomachi Shinjuku-ku Tokyo Japan
TEL	03-5353-3710
Email	n-hasegawa@z8.keio.jp

Public contact
Name of contact person	1st name Middle name Last name Naoki Hasegawa
Organization	Keio University Hospital
Division name	Infection control center
Zip code
Address	35 Shinanomachi Shinjuku-ku Tokyo Japan
TEL	03-5363-3710
Homepage URL
Email	n-hasegawa@z8.keio.jp

Sponsor
Institute	Keio University Hospital
Institute
Department

Funding Source
Organization	Keio University Hospital Department of Respirology
Organization
Division
Category of Funding Organization	Self funding
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	2010 Year 10 Month 14 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	2010 Year 08 Month 10 Day
Date of IRB	2010 Year 08 Month 10 Day
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 10 Month 14 Day
Last modified on	2019 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005243