UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009837
Receipt number R000011519
Scientific Title Multicenter Prospective Study for the Prediction of Drug-Resistant Pathogens in Hospitalized Patients with Community-Acquired Pneumonia and Healthcare-Associated Pneumonia in Japan (CJLSG 1205)
Date of disclosure of the study information 2013/01/24
Last modified on 2018/10/12 15:32:13

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Basic information

Public title

Multicenter Prospective Study for the Prediction of Drug-Resistant Pathogens in Hospitalized Patients with Community-Acquired Pneumonia and Healthcare-Associated Pneumonia in Japan (CJLSG 1205)

Acronym

Multicenter Prospective Study for the Prediction of Drug-Resistant Pathogens in CAP and HCAP (CJLSG 1205)

Scientific Title

Multicenter Prospective Study for the Prediction of Drug-Resistant Pathogens in Hospitalized Patients with Community-Acquired Pneumonia and Healthcare-Associated Pneumonia in Japan (CJLSG 1205)

Scientific Title:Acronym

Multicenter Prospective Study for the Prediction of Drug-Resistant Pathogens in CAP and HCAP (CJLSG 1205)

Region

Japan


Condition

Condition

Community-Acquired Pneumonia (CAP) and Healthcare-Associated Pneumonia (HCAP)

Classification by specialty

Pneumology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To validate the prediction rule for drug-resistant pathogen identification proposed by the CJLSG0911 Study (UMIN000003306), and to examine the factors for disease severity in patients with CAP and HCAP

Basic objectives2

Others

Basic objectives -Others

Validation of the prediction rule for drug-resistant pathogens proposed by the CJLSG0911 Study

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Identified pathogens and drug resistance (especially which are not susceptible to beta-lactams, macrolides, and respiratory fluoroquinolones)

Key secondary outcomes

1) Presence or absence of serious illness and the time to develop
2) 30-day mortality and in-hospital mortality
3) Early and late treatment failure


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

Presence of a new infiltrate on a chest radiograph in addition to at least two of the following: 1) new or increased cough or sputum production, 2) pleuritic chest pain, 3) new or increased dyspnea, 4) fever (temperature =>38.0 degrees) or hypothermia (temperature <35.0 degrees), 5) white blood cell count >=10,000 /mm3 or <4,000 /mm3, and 6) new hypoxemia (SpO2 <90% or PaO2 <60 Torr) or deterioration of hypoxemia

Key exclusion criteria

1) Patients with obstructive pneumonia
2) Patients who do not receive initial empirical antibiotic treatment
3) Pneumonia that occurs 48 hours or more after admission
4) Patients who were transferred from other instructions and were already clinically improved
5) Patients who had been previously enrolled in this study

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinori Hasegawa

Organization

Nagoya University Graduate School of Medicine

Division name

Respiratory Medicine

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2167

Email

dkoba@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Kobayashi

Organization

Nagoya University Graduate School of Medicine

Division name

Respiratory Medicine

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2167

Homepage URL


Email

dkoba@med.nagoya-u.ac.jp


Sponsor or person

Institute

Central Japan Lung Study Group

Institute

Department

Personal name



Funding Source

Organization

Central Japan Lung Study Group

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

名古屋大学医学部附属病院(愛知県)、トヨタ記念病院(愛知県)、公立陶生病院(愛知県)、名古屋第二赤十字病院(愛知県)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 24 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.dovepress.com/validation-of-the-prediction-rules-identifying-drug-resistant-pathogen-pee

Number of participants that the trial has enrolled


Results

Infection and Drug Resistance; 11: 1703-1713, 2018

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 01 Month 22 Day

Date of IRB


Anticipated trial start date

2013 Year 04 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

This study is a prospective observational study.


Management information

Registered date

2013 Year 01 Month 22 Day

Last modified on

2018 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011519


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name