UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Yoshinori Hasegawa
Organization	Nagoya University Graduate School of Medicine
Division name	Respiratory Medicine
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	Daisuke Kobayashi
Organization	Nagoya University Graduate School of Medicine
Division name	Respiratory Medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2167
Homepage URL
Email	dkoba@med.nagoya-u.ac.jp

Sponsor
Institute	Central Japan Lung Study Group
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.dovepress.com/validation-of-the-prediction-rules-identifying-drug-resistant-pathogen-pee
Results	Infection and Drug Resistance; 11: 1703-1713, 2018
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011519