UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004279
Receipt number R000005130
Scientific Title Antimicrobial Susceptibility in Identified Microbes Among Hospitalized Patients with Pneumonia (Additional Study of CJLSG 0911)
Date of disclosure of the study information 2010/09/28
Last modified on 2021/10/26 09:08:04

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Basic information

Public title

Antimicrobial Susceptibility in Identified Microbes Among Hospitalized Patients with Pneumonia (Additional Study of CJLSG 0911)

Acronym

Antimicrobial Susceptibility in Identified Microbes Among Hospitalized Patients with Pneumonia

Scientific Title

Antimicrobial Susceptibility in Identified Microbes Among Hospitalized Patients with Pneumonia (Additional Study of CJLSG 0911)

Scientific Title:Acronym

Antimicrobial Susceptibility in Identified Microbes Among Hospitalized Patients with Pneumonia

Region

Japan


Condition

Condition

Community-acquired pneumonia (CAP), health-care-associated pneumonia (HCAP), hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP)pneumonia (VAP)

Classification by specialty

Pneumology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

- To propose the appropriate initial antibiotic empirical treatment for patients with CAP, HCAP, HAP, and VAP, by investigating antimicrobial susceptibility in identified microbes among those patients.
- To investigate mechanisms for drug resistance in identified microbes.
- To propose the appropriate infection control practice, by molecular epidemiological analyses of identified microbes.

Basic objectives2

Others

Basic objectives -Others

Antimicrobial susceptibilities, mechanisms for drug resistance, and differences in molecular epidemiological findings, etc. in identified microbes among patients with CAP, HCAP, HAP, and VAP.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

1) Antimicrobial susceptibilities in identified microbes.
2) The frequency of each identified microbe and those proportion of drug resistance in patients with CAP, HCAP, HAP, and VAP.
3) Mechanisms for drug resistance in identified microbes in patients with CAP, HCAP, HAP, and VAP.
4) Differences in molecular epidemiological findings in identified microbes among patients with CAP, HCAP, HAP, and VAP.

Key secondary outcomes



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

The presence of a new infiltrate on a chest X-ray, or a computed tomography scan, plus at least 2 of the following criteria: 1) cough or purulent sputum, 2) pleuritic chest pain, 3) dyspnea, 4) fever or hypothermia (temperature >= 38 degrees or < 35 degrees), 5) white blood cell count >= 10,000 /mm3 or < 4,000 /mm3, and 6) hypoxemia (SpO2 < 90% or PaO2 < 60 Torr) or decline in oxygenation.

Key exclusion criteria

1) Patients who do not receive initial empirical antibiotic treatment.
2) Patients with obstructive pneumonia.
3) Pneumonia occurred in other hospitals and patients who were transferred from their hospitals with a tendency to improve.
4) Patients whose pneumonia recurred within 3 days after the last day of antibiotic treatment of a preceding pneumonia episode.
5) Patients who receive the treatment in an outpatient clinic.
6) Patients who are less than 20 years old.

Target sample size

1200


Research contact person

Name of lead principal investigator

1st name Yuichiro
Middle name
Last name Shindo

Organization

Nagoya University Hospital

Division name

Respiratory Medicine

Zip code

466-8550

Address

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

TEL

052-744-2167

Email

yshindo@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Yuichiro
Middle name
Last name Shindo

Organization

Nagoya University Hospital

Division name

Respiratory Medicine

Zip code

466-8550

Address

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

TEL

052-744-2167

Homepage URL


Email

yshindo@med.nagoya-u.ac.jp


Sponsor or person

Institute

Central Japan Lung Study Group

Institute

Department

Personal name



Funding Source

Organization

Department of Respiratory Medicine, Nagoya University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Infectious Diseases, Nagoya University Hospital

Name of secondary funder(s)

Central Japan Lung Study Group


IRB Contact (For public release)

Organization

Nagoya University Hospital, Institutional Review Board

Address

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

Tel

052-744-2500

Email

ethics@med.nagoya-u.ac.jp


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)
JA愛知厚生連豊田厚生病院(愛知県)
トヨタ記念病院(愛知県)
大垣市民病院(岐阜県)
公立陶生病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
名古屋掖済会病院(愛知県)
豊橋市民病院(愛知県)
名古屋第一赤十字病院(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

2010 Year 09 Month 28 Day


Related information

URL releasing protocol

http://www.cjlsg.jp/activity.html

Publication of results

Published


Result

URL related to results and publications

https://journals.asm.org/doi/10.1128/JCM.03067-14?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rf

Number of participants that the trial has enrolled

120

Results

Results of this study have been partially published:
- http://www.ncbi.nlm.nih.gov/pubmed/25568434
- https://journals.asm.org/doi/10.1128/JCM.03067-14?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

Results date posted

2021 Year 10 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2015 Year 02 Month 19 Day

Baseline Characteristics

Nosocomial pneumonia (hospital-acquired pneumonia and ventilator-associated pneumonia), neoplastic disease, immunosuppression, systolic blood pressure (SBP) <90 mmHg, respiratory rate (RR) >=30/min, and albumin <3.0 mg/dl (hypoalbuminemia) were more frequent in patients with bacteremia than in those without bacteremia. The SOFA score was higher in patients with bacteremia than in those without.

Participant flow

One hundred and two patients from the previous cohort study (18) and 18 patients from Nagoya University Hospital made a total of 120 patients with pneumonia due to K. pneumoniae included in the present study. Among them, 23 (19.2%) were classified as bacteremia, and 97 (80.8%) were classified as non-bacteremia.

Adverse events

None

Outcome measures

Bacteremia due to K. pneumoniae

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 05 Month 07 Day

Date of IRB

2010 Year 06 Month 24 Day

Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date

2011 Year 05 Month 01 Day

Date of closure to data entry

2013 Year 03 Month 01 Day

Date trial data considered complete

2014 Year 03 Month 01 Day

Date analysis concluded

2014 Year 03 Month 01 Day


Other

Other related information

- This is an additional study of CJLSG 0911, entitled "Epidemiological Study for Hospitalized Patients with Community-acquired, Health-care-associated, Hospital-acquired, and Ventilator-associated Pneumonia in Japan: a Prospective Multicenter Follow-up Study" (UMIN000003306).
- Microbes, used in this study, are those which are identified in patients who have been enrolled in the CJLSG 0911 study.
- The start date of enrollment is the date that the collection of microbes was started.


Management information

Registered date

2010 Year 09 Month 28 Day

Last modified on

2021 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005130


Research Plan
Registered date File name

Research case data specifications
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Research case data
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