UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008010
Receipt No. R000009420
Scientific Title Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy for the treatment of bacterial pneumonia.
Date of disclosure of the study information 2012/05/23
Last modified on 2017/01/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy for the treatment of bacterial pneumonia.
Acronym Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy (YCRG0008)
Scientific Title Clinical study to evaluate anti-inflammatory effects of intravenous azithromycin add-on therapy for the treatment of bacterial pneumonia.
Scientific Title:Acronym 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
1st name
Middle name
Last name Takeshi Kaneko
Organization Yokohama City University Medical Center
Division name Respiratory Disease Center
Zip code
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
1st name
Middle name
Last name Masaharu Shinkai
Organization Yokohama City University Medical Center
Division name Respiratory Disease Center
Zip code
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)

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 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

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 Terminated
Date of protocol fixation
2012 Year 03 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.