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
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
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
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
