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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034673
Receipt No. R000039531
Scientific Title Exploration of predictive factors for prognosis of community-onset pneumonia in adults: a multicenter prospective observational study
Date of disclosure of the study information 2018/11/29
Last modified on 2019/05/07

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Basic information
Public title Exploration of predictive factors for prognosis of community-onset pneumonia in adults: a multicenter prospective observational study
Acronym Exploration of predictive factors for prognosis of community-onset pneumonia in adults
Scientific Title Exploration of predictive factors for prognosis of community-onset pneumonia in adults: a multicenter prospective observational study
Scientific Title:Acronym Exploration of predictive factors for prognosis of community-onset pneumonia in adults
Region
Japan

Condition
Condition community-onset pneumonia
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate predictors of prognosis and clinical course in adult patients with community-onset pneumonia (COP).
Basic objectives2 Others
Basic objectives -Others To assess potential predictors of clinical course and prognosis in COP patients, such as patient backgrounds, clinical findings, laboratory findings (e.g. biomarkers), disease severity including SOFA and qSOFA scores, causative organisms, and treatment drugs.

To investigate actual situation of severity-guided management of adult patients with COP in daily clinical practice and evaluate observance level and validity of the Japanese Respiratory Society guidelines for the management of pneumonia in adults 2017 (JRS guidelines).
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Thirty-day mortality and prognostic factors
Key secondary outcomes Predictors of treatment failure at Day 3, end of treatment, and test of cure (5-10 days after end of treatment)

Causative organisms and antimicrobial susceptibilities

Severity (A-DROP, PSI, PORT, qSOFA, SOFA and APACHE-II scores)

Actual situation of severity-guided management of adult patients with COP and observance rate of the JRS guidelines

Biomarkers associated with causative organisms, severity, and clinical course

Safety of administered antibiotics (adverse events occurred between Day 0 and TOC)

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 Evidence of a signed and dated informed consent form indicating that the patient or legally acceptable representative(s) have been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for participation in the study:

(1) Age: 20 years old and above

(2) Diagnosed as COP clinically and having at least two of the following signs/symptoms compatible with pneumonia:
- Cough (either productive or dry)
- Purulent sputum
- Abnormal findings in auscultation and/or percussion (moist rales, respiratory sound attenuation, abnormal dullness in percussion, etc.)
- Dyspnea and/or tachypnea
- Fever (measured axillary temperature of 37 degree Celsius or above)
- WBC >10,000/mm3, or >15% bands, or WBC <4,500/mm3
- Elevated CRP value (over the upper limit of institutional reference value)
- Hypoxemia (PaO2<60 Torr, or SpO2<90%)

(3) Showing a pneumonia pattern (e.g. alveolar infiltrative shadow associated with air bronchogram) on chest X-ray or chest CT within the past 48 hours.
Key exclusion criteria - Any subject who is transferred to a participating medical institution after already being hospitalized for 48 hours or more at any other hospital.
- Hospital acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more)
- Previous enrollment in this study within the past 30 days.
- Any subject who has received effective antibacterial drug therapy for the current pneumonia and improvement is observed (Note: subjects who have received antibacterial agents for a continuous duration of more than 3 days for the current pneumonia and considered as treatment failure based on the investigators judgment are allowed).
- Any subject who has received azithromycin during the previous 7 days.
- Any subject who has a concurrent condition or infection that, in the investigators judgment, would preclude evaluation of therapeutic response (e.g. advanced cancer, primary or metastatic lung cancer, severe heart failure, cystic fibrosis, AIDS, pneumocystis pneumonia, active tuberculosis)
- Any subject who has a history or current condition, therapy, laboratory abnormality, or other circumstance that, in the opinion of the investigator, might confound the results of the study or interfere with the participation for the full duration of the study.

Note: Subjects who are anticipated to be treated with any of the following medications during the course of study are allowed: long-term low-dose macrolide therapy without change of dosage, intravenous/oral/inhaled prednisolone (<10 mg/day) without change of dosage, immunosuppressive agents without change of dosage, and antipyretic analgesics taken as a one-shot-medicine.
Target sample size 220

Research contact person
Name of lead principal investigator
1st name Taiga
Middle name
Last name Miyazaki
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Infectious Disease
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL 095-819-7273
Email taiga-m@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Taiga
Middle name
Last name Miyazaki
Organization Nagasaki University Hospital
Division name Department of Respiratory Medicine (Second Department of Internal Medicine)
Zip code 852-8501
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL 095-819-7273
Homepage URL
Email taiga-m@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization - Astellas Investigator Sponsored Research Program
- Taisho Toyama Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Clinical Research Center, Nagasaki University Hospital
Address 1-7-1 Sakamoto, Nagasaki
Tel 095-819-7726
Email rinshou7726@umin.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 長崎大学病院(長崎県)、日本赤十字社 長崎原爆病院(長崎県)、長崎みなとメディカルセンター市民病院(長崎県)、社会福祉法人恩賜財団済生会支部 済生会長崎病院(長崎県)、重工記念長崎病院(長崎県)、医療法人 光晴会病院(長崎県)、日本赤十字社 長崎原爆諫早病院(長崎県)、独立行政法人 地域医療機能推進機構 諫早総合病院(長崎県)、医療法人伴帥会 愛野記念病院(長崎県)、独立行政法人国立病院機構 長崎医療センター(長崎県)、地方独立行政法人 佐世保市総合医療センター(長崎県)、社会医療法人財団白十字会 佐世保中央病院(長崎県)、独立行政法人国立病院機構 嬉野医療センター(佐賀県)、産業医科大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
2018 Year 09 Month 11 Day
Anticipated trial start date
2018 Year 11 Month 29 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The following items will be investigated:
- Patient backgrounds: Medical history and underlying diseases will be recorded.
- Clinical findings: Clinical symptoms/signs, results of blood examination, radiological findings (chest X-ray/CT) will be recorded.
- Severity: The degree of severity of COP patients will be assessed based on information of A-DROP, CURB-65, pneumonia severity index (PSI)/Pneumonia Outcomes Research Team (PORT) score, quick SOFA (qSOFA) and SOFA scores, septic shock, artificial respiration management, and ICU admission. The assessments will be performed at Day 0 based on information collected between presumed onset time and Day 0, given that the date of obtainment of informed consent is Day 0.
- Causative organisms: Respiratory specimens (for example, sputum, intratracheal aspirated sputum, nasopharyngeal swab, bronchoalveolar lavage fluid, pleural effusion), blood, urine and other aseptic specimens (e.g. cerebrospinal fluid, if obtained as a usual medical care) will be examined.
- Safety of administered antibiotics: Adverse events occurred between Day 0 and test of cure (TOC), which is 5 to 10 days after end of treatment (EOT), will be collected.
- Treatment response: Clinical and microbiological response will be evaluated at Day 3, EOT and TOC.
- Prognosis: The vital status of the patient until day 30 will be checked.

Management information
Registered date
2018 Year 10 Month 28 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039531

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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