UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004387 |
|---|---|
| Receipt number | R000005243 |
| Scientific Title | Effect of Garenoxacin to fever and pro-inflamatory cytokine with bronchoscopy |
| Date of disclosure of the study information | 2010/10/14 |
| Last modified on | 2019/06/21 20:55:45 |
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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
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
n-hasegawa@z8.keio.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005243
