UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy for the treatment of bacterial pneumonia.
Title of the study (Brief title)	Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy (YCRG0008)
Region	Japan

Condition
Condition	Pneumonia
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare anti-inflammatory effects and efficacy of beta-lactum plus intravenous azithromycin with beta-lactum plus levofloxacin in moderate to severe bacterial peumonia patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Reduction rates of serum IL-8 levels over time
Key secondary outcomes	(1) Changes in biomarkers measured during treatment (2) Recovery rates of acquired pneumonia in each treatment group (3) Microbiological effective rates in each treatment group (4) Survival rates of patients on 30 days after each treatment (5) Evaluation of adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment group: Sequential administration of beta-lactam plus azithromycin (500 mg for 120 min). Treatment to be continued if there was no improvement in inflammatory responses and radiological findings . Blood samplings on day0, day3, day5, day7 and day10. Sputum cultures taken before and after each treatment. If needed, pharyngeal swab and urine antigen tests etc.
Interventions/Control_2	Control group: Sequential administration of beta-lactam plus levofloxacin (500 mg for 60 min). Treatment to be continued if there was no improvement in inflammatory responses and radiological findings . Blood samplings on day0, day3, day5, day7 and day10. Sputum cultures taken before and after each treatment. If needed, pharyngeal swab and urine antigen tests etc.
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	16 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Inclusion criteria: (1) Patient with be from 16 to 85-years old (2) Moderate to severe pneumonia patents that needed to be hospitalized (3) Patient without long-term oral steroid treatment (4) Patients who are agreed with the study enrollment
Key exclusion criteria	Exclusion criteria: (1) Patients with hypersensitivity to azithromycin, macrolide or ketolide antibiotic agents (2) Patients with hypersensitivity to levofloxacin or ofloxacin (3) Patients with liver dysfunction (AST, ALT, and total bilirubin > 3 times upper limit of normal range) (4) Patients with severe renal dysfunction (creatinine clearance <30 mL/min) (5) Patients with prior or current evidence of severe heart diseases (NYHA grade IV), congenital or sporadic prolongation of the QT interval, or receiving medications known to cause prolongation of the QT interval (6) Patients with severe underlying diseases or complications that have the difficulties of the evaluations of drug efficacy (7) Patients who require other systemic antibiotic treatments (8)Patients by whom other antimicrobial drugs (internal use or injection) were prescribed for the patient exceeding 48 hours to this infection before investigational new drug trial drug medication (9)Patients with gastrointestinal disorders disrupting drug absorption (10)Pregnant women or females with childbearing potential (11) Any other condition which, in the opinion of the investigator, would make the subject unsuitable for enrollment
Target sample size	80

Research contact person
Name of lead principal investigator	Takeshi Kaneko
Organization	Yokohama City University Medical Center
Division name	Respiratory Disease Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	takeshi@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Masaharu Shinkai
Organization	Yokohama City University Medical Center
Division name	Respiratory Disease Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	shinkai@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	横浜市立大学附属市民総合医療センター（神奈川県） 大和市立病院（神奈川県） 神奈川県立がんセンター（神奈川県） 藤沢市民病院（神奈川県） 関東労災病院（神奈川県） 横浜南共済病院（神奈川県） 横浜市立大学附属病院（神奈川県） 防衛医科大学校病院（埼玉県） 国立病院機構横浜医療センター（神奈川県） 横浜栄共済病院（神奈川県） 済生会横浜市南部病院（神奈川県） 横浜船員保険病院（神奈川県） 茅ヶ崎市立病院（神奈川県） 横須賀市立市民病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 23 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 01 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 22 Day
Last modified on	2017 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009420