UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010368 |
|---|---|
| Receipt number | R000011897 |
| Scientific Title | Evaluation of the effectiveness of the preoperative administration of a single-dose preparationof azithromycin, in chest surgery. |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2019/10/12 18:29:30 |
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Basic information
Public title
Evaluation of the effectiveness of the preoperative administration of a single-dose preparationof azithromycin, in chest surgery.
Acronym
Evaluation of the preoperative administration of a single-dose preparationof azithromycin.
Scientific Title
Evaluation of the effectiveness of the preoperative administration of a single-dose preparationof azithromycin, in chest surgery.
Scientific Title:Acronym
Evaluation of the preoperative administration of a single-dose preparationof azithromycin.
Region
| Japan |
Condition
Condition
primary lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
perioperative infection prophylaxis in lung cancer surgery.
Basic objectives2
Others
Basic objectives -Others
concentration of azithromycin in lung, microbiological examination in lung, inflammatory cytokines expression.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
perioperative infection prophylaxis in lung cancer surgery.
Key secondary outcomes
concentration of azithromycin in lung, microbiological examination in lung, inflammatory cytokines expression.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
preoperative administration of a single-dose preparation of azithromycin
Interventions/Control_2
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are planned to be performed surgery for primary lung cancer in our center
Key exclusion criteria
(1) patient with hypersensitivity to azithromycin or macrolide derivative antimicrobials
(2)patinet with congenital long QT, bradycardia, arrhythmia, heart failure or electrolyte disorders such as hyperkalemia and hypomagnesemia, or patient receiving long QT-inducible drugs such as class IA or III antiarrhythmic, psychotropic and antidepressant
(3)patient with severe liver dysfunction(Child Pugh C)
(4)patient of aherediatry fructose intolerance symptom, glucose galactose absoroption imperfecton or sucrose isomaltase deficiency
(5)patient recieving other antimicrobials
(6)A pregnant woman or the patient who is nursing
(7)the patient who is judged to be inappropriate by the examination medical attendant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nagayasu |
Organization
Nagasaki University Hospital
Division name
Surgical Oncology
Zip code
Address
Sakamoto1-7-1, Nagasaki
TEL
095-819-7304
nagayasu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironosuke Watanabe |
Organization
Nagasaki University Hospital
Division name
Surgical Oncology
Zip code
Address
Sakamoto17-1, Nagasaki
TEL
095-819-7304
Homepage URL
hironosuke3689@yahoo.co.jp
Sponsor or person
Institute
Surgical Oncology, Nagasaki University Hospital
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
| 2013 | Year | 04 | 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
| 2013 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 30 | Day |
Last modified on
| 2019 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011897
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
