UMIN-CTR Clinical Trial

Basic information
Public title	Severity scores for predicting mortality, risk factors for drug-resistant pathogens, and the sputum Gram stain test in nursing and health care-associated pneumonia: an observational study
Acronym	An observational study of nursing and health care-associated pneumonia
Scientific Title	Severity scores for predicting mortality, risk factors for drug-resistant pathogens, and the sputum Gram stain test in nursing and health care-associated pneumonia: an observational study
Scientific Title:Acronym	An observational study of nursing and health care-associated pneumonia
Region	Japan

Condition
Condition	Nursing and healthcare-associated pneumonia
Classification by specialty	Medicine in general Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To validate propsed severity scores for predicting mortality in nursing and health care-associated pneumonia
Basic objectives2	Others
Basic objectives -Others	To validate risk factors or models for drug-resistant pathogens, and clinical roles of the sputum Gram stain test in nursing and health care-associated pneumonia
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Model performance (discrimination and calibration) of A-DROP, a proposed pneumonia severity score for predicting 30-day mortality
Key secondary outcomes	1) Model performance (discrimination and calibration) of other proposed pneumonia severity scores (PSI, C(U)RB-65) for predicting 30-day mortality 2) Predictive ability of proposed risk factors or model performance of proposed indexes for predicting drug-resistant pathogens 3) Percent of change in the selection of first-line antibiotic regimens (from empirical regimens to the Gram stain test-based focussed/narrower regimens) 4) The impact of the Gram stain test upon primary treatment failure, 30-day mortality, and 100-day mortality

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Newly diagnosed pneumonia meeting at least one of the following criteria (from a through e, see below), where pneumonia is defined as 1) the presence of a new infiltrate on a chest radiograph plus at least one of the following sumptoms or signs: fever (temperature >38.0 Celsius) or hypothermia (temperature <35.0 Celsius), new cough with or without sputum production, pleuritic chest pain, dyspnea, and altered breath sounds on auscultation (Carratala et al, Ann Intern Med 2005). 2. Criteria a. Hospitalization for at least 2 days within 90 days prior to the onset of pneumonia b. Residence in a nursing home or long-term care facility c. Taking outpatient intravenous therapy (antibiotics, chemotherapy, immunosuppressive drugs, etc.) d. Undergoing chronic dialysis treatment e. Disabled or elderly people in poor performance status (ECOG PS 3 and 4) 3. Agreeing to participate the study 4. Provision of a signed Written Informed Consent
Key exclusion criteria	Not agreeing to participate the study
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Katsuo Middle name Last name Yamanaka
Organization	Fujita Health University School of Medicine
Division name	Department of Emergency and General Internal Medicine
Zip code	470-1192
Address	1-98 Dengakugakubo, Kutsukakecho, Toyoake, Aichi, 470-1192 Japan
TEL	0562-93-2355
Email	yamanakk@gmail.com

Public contact
Name of contact person	1st name Teruhiko Middle name Last name Terasawa
Organization	Fujita Health University School of Medicine
Division name	Department of Emergency and General Internal Medicine
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukakecho, Toyoake, Aichi, 470-1192 Japan
TEL	0562-93-2355
Homepage URL
Email	terasawa@fujita-hu.ac.jp

Sponsor
Institute	Department of Emergency and General Internal Medicine, Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research, Ministry of Education, Culture, Sports, Science and Technology, Japan; Fujita Health University, Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fujita Health University
Address	1-98 Dengakugakubo, Kutsukakecho, Toyoake, Aichi, 470-1192 Japan
Tel	0562-93-2635
Email	honbu-sg@fujita-hu.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	藤田保健衛生大学病院

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 05 Day

Related information
URL releasing protocol	Not available
Publication of results	Unpublished

Result
URL related to results and publications	Not available
Number of participants that the trial has enrolled	31
Results	Since this study was a prospective observational study that required patient consent form, the proportion of patients who disagreed was overwhelmingly large. Due to very few numbers of consented cases, which degraded the external validity of the study, the study was terminated.
Results date posted	2022 Year 07 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Early termination. No results.
Participant flow	Early termination. No results.
Adverse events	Early termination. No results.
Outcome measures	Early termination. No results.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 03 Month 19 Day
Date of IRB	2014 Year 02 Month 06 Day
Anticipated trial start date	2014 Year 04 Month 05 Day
Last follow-up date	2018 Year 05 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Data collection 1) Patient background Age, gender, past history and existing/concurrent disease (malignancy, diabetes, liver disease, heart failure, cerebrovascular disease, kidney disease, COPD), antimicrobial therapy within 90 days prior, dialysis therapy, chemotherapy, immunosuppressive drugs), tube feeding, medications (especially H2-receptor antagonists, proton-pomp inhibitors, antibiotics, anti-cancer agents, immunosuppressive agents, steroids), poor performance status (e.g., wheelchair- or bed-ridden) 2) Clinical data Presence or absence of shock, necessity and implementation of mechanical ventilation, impaired level of consciousness, blood pressure, heart rate, respiratory rate, body temperature, SpO2 Chest X-ray findings, sputum culture, Gram stain test Arterial blood gas analysis (pO2, pH) Complete blood counts, serum sodium, blood glucose, serum urea nitrogen, serum albumin A tentatively selected empirical antibiotic regimen before determining an actual primary antibiotic regimen based on the Gram stain test 3) Clinical outcomes Clinically identified causative pathogens of pneumonia Primary treatment success and the actual antimicrobial regimen 30-day survival 100-day survival

Management information
Registered date	2014 Year 04 Month 05 Day
Last modified on	2022 Year 07 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015930