UMIN-CTR Clinical Trial

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

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

Classification by specialty

Pneumology

Infectious disease

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Central Japan Lung Study Group

Institute

Department

Personal name

Organization

Central Japan Lung Study Group

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

01

Month

24

Day

URL releasing protocol

Publication of results

Published

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

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 related information

This study is a prospective observational study.

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