UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008010
Receipt number 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 12:52:00

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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 or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



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

Value
https://center6.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