UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012685
Receipt number R000014820
Scientific Title Efficacy and safety of doripenem (3g/day) in the treatment of severe/refractory respiratory infections
Date of disclosure of the study information 2013/12/25
Last modified on 2016/10/04 15:11:06

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Basic information

Public title

Efficacy and safety of doripenem (3g/day) in the treatment of severe/refractory respiratory infections

Acronym

Efficacy and safety of doripenem (3g/day) in the treatment of severe/refractory respiratory infections

Scientific Title

Efficacy and safety of doripenem (3g/day) in the treatment of severe/refractory respiratory infections

Scientific Title:Acronym

Efficacy and safety of doripenem (3g/day) in the treatment of severe/refractory respiratory infections

Region

Japan


Condition

Condition

severe/refractory respiratory infections

Classification by specialty

Pneumology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of efficacy and safety of doripenem (3g/day) in the treatment in patients with severe/refractory respiratory infections.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinical efficacy at the end of doripenem (3g/day) administration

Key secondary outcomes



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

Doripenem (3g/day) is given intravenously

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients 20 years of age and older
2.Patients with severe/very severe pneumonia according to the Japan Respiratory Society Guidelines for the Management of Community-Acquired Pneumonia or Healthcare-associated Pneumonia in Adults .

Key exclusion criteria

1.Patients who had been treated with doripenem
2.Contraindication for doripenem
3.Liver insufficiency (elevated levels of AST/ALT more than 5 times of the upper limits)
4.Renal insufficiency (elevated levels of BUN/creatinine more than 2 times of the upper limits)
5.Patients anticipating being susceptive of convulsion after brain disorders
6.Patients deemed ineligible by the attending physicians for various reasons.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshinori Kawanami

Organization

University of Occupational and Environmental Health, Japan

Division name

Department of Respiratory Medicine

Zip code


Address

1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan

TEL

093-603-1611

Email

namihei@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshinori Kawanami

Organization

University of Occupational and Environmental Health, Japan

Division name

Department of Respiratory Medicine

Zip code


Address

1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan

TEL

093-603-1611

Homepage URL


Email

namihei@med.uoeh-u.ac.jp


Sponsor or person

Institute

Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan

Institute

Department

Personal name



Funding Source

Organization

Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan

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



Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 25 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 10 Month 16 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 16 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

2013 Year 12 Month 25 Day

Last modified on

2016 Year 10 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014820


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name