UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042522
Receipt number R000048542
Scientific Title Japanese, multi-center, observational study for hospitalized patients with community-acquired, hospital-acquired, and ventilator-associated pneumonia
Date of disclosure of the study information 2020/11/24
Last modified on 2021/02/20 17:06:15

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Basic information

Public title

Japanese, multi-center, observational study for hospitalized patients with community-acquired, hospital-acquired, and ventilator-associated pneumonia

Acronym

J-CAPTAIN

Scientific Title

Japanese, multi-center, observational study for hospitalized patients with community-acquired, hospital-acquired, and ventilator-associated pneumonia

Scientific Title:Acronym

J-CAPTAIN

Region

Japan


Condition

Condition

Community-acquired (CAP) including COVID-19, hospital-acquired (HAP), and ventilator-associated pneumonia (VAP)

Classification by specialty

Pneumology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

- To investigate clinical and microbiological features in patients with CAP (including COVID-19), HAP, and VAP, including backgrounds, outcomes, clinical courses, identified pathogens, antimicrobial susceptibilities, and risk factors for drug resistant pathogens
- To propose appropriate initial assessment methods and appropriate therapeutic strategies for patients with CAP (including COVID-19), HAP, and VAP

Basic objectives2

Others

Basic objectives -Others

Backgrounds, outcomes, clinical courses, identified pathogens and their drug resistance, antimicrobial susceptibilities, etc.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

1) 30-day mortality, 90-day mortality and in-hospital mortality
2) Identified pathogens and drug resistance
3) Early and late treatment failure
4) Severe adverse events
5) Readmission within 90 days after discharge
6) Appropriateness of antibiotic treatment

Key secondary outcomes



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

The presence of a new infiltrate on a chest X-ray, or a computed tomography scan, plus at least one of the following criteria: 1) cough or purulent sputum, 2) pleuritic chest pain, 3) dyspnea, 4) fever or hypothermia (temperature >= 37.5 degrees or < 35 degrees), 5) white blood cell count >= 10,000 /mm3 or < 4,000 /mm3, 6) increase of CRP or PCT values above the upper limit of facility reference value and 7) hypoxemia (SpO2 < 90% or PaO2 < 60 Torr) or decline in oxygenation.

Key exclusion criteria

1) Patients who do not receive initial empirical antibiotic treatment
2) Patients with obstructive pneumonia
3) Pneumonia occurred in other hospitals and patients who were transferred from their hospitals with a trend toward improvement
4) Patients whose pneumonia recurred within 3 days after the last day of antibiotic treatment of a preceding pneumonia episode
5) Patients who receive the treatment in outpatient clinics
6) Patients who are less than 20 years old

Target sample size

1500


Research contact person

Name of lead principal investigator

1st name Yuichiro
Middle name Shindo
Last name Shindo

Organization

Nagoya University Hospital

Division name

Respiratory Medicine

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

0527442167

Email

yshindo@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Yuichiro
Middle name
Last name Shindo

Organization

Nagoya University Hospital

Division name

Respiratory Medicine

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

0527442167

Homepage URL


Email

yshindo@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Respiratory Medicine, Nagoya University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagoya University Hospital, Institutional Review Board

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

Tel

052-744-2423

Email

iga-shinsa@adm.nagoya-u.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

名古屋大学医学部附属病院(愛知県)
公立陶生病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
トヨタ記念病院(愛知県)
名古屋掖済会病院(愛知県)
名古屋第二赤十字病院(愛知県)
岐阜県立多治見病院(岐阜県)
中東遠総合医療センター(静岡県)
中部ろうさい病院(愛知県)
常滑市民病院(愛知県)
小牧市民病院(愛知県)
名城病院(愛知県)
中京病院(愛知県)
春日井市民病院(愛知県)


Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 24 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

Enrolling by invitation

Date of protocol fixation

2020 Year 03 Month 28 Day

Date of IRB

2020 Year 04 Month 10 Day

Anticipated trial start date

2020 Year 11 Month 24 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

- Start date of patient enrollment for the prospective study: 2020/11/24
- This study also collects patient data retrospectively for patients who were diagnosed as having pneumonia after 2020/1/1.
- When we show study results in only patients with community-acquired pneumonia (CAP), the research title will be "Japanese, multi-center, observational study for patients with community-acquired pneumonia requiring hospitalization (J-CAPTAIN)".


Management information

Registered date

2020 Year 11 Month 23 Day

Last modified on

2021 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048542


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name