UMIN-CTR Clinical Trial

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
Institute	Central Japan Lung Study Group
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005130