UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013648
Receipt number R000015930
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
Date of disclosure of the study information 2014/04/05
Last modified on 2022/07/09 11:49:12

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015930


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name