UMIN-CTR Clinical Trial

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
Email	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
Email	hironosuke3689@yahoo.co.jp

Sponsor
Institute	Surgical Oncology, Nagasaki University Hospital
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011897