UMIN-CTR Clinical Trial

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

community-onset pneumonia

Classification by specialty

Medicine in general	Pneumology	Infectious disease

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nagasaki University

Institute

Department

Personal name

Organization

- Astellas Investigator Sponsored Research Program
- Taisho Toyama Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Research Center, Nagasaki University Hospital

Address

1-7-1 Sakamoto, Nagasaki

Tel

095-819-7726

Email

rinshou7726@umin.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2018

Year

11

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

2103

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

Recruitment status

No longer 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 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.

Registered date

2018

Year

10

Month

28

Day

Last modified on

2022

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039531