UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042594
Receipt number R000048462
Scientific Title Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (REMAP-CAP) in Japan
Date of disclosure of the study information 2020/11/30
Last modified on 2021/09/27 18:51:19

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Basic information

Public title

A Platform Trial of Optimal Treatment for Pneumonia including (Re-)Emerging Infections

Acronym

A Platform Trial of Optimal Treatment for Pneumonia including (Re-)Emerging Infections

Scientific Title

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (REMAP-CAP) in Japan

Scientific Title:Acronym

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (REMAP-CAP) in Japan

Region

Japan


Condition

Condition

Community-acquired pneumonia

Classification by specialty

Pneumology Infectious disease Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

All-cause mortality (Time Frame: Day 90)

Key secondary outcomes

1 ICU Mortality (Time Frame: Day 90)
2 ICU length of stay (Time Frame: Day 90)
3 Hospital length of stay (Time Frame: Day 90 )
4 Ventilator free days (Time Frame: Day 28)
5 Organ failure free days (Time Frame: Day 28)
6 All-cause mortality (Time Frame: 6 months)
7 Health-related Quality of life assessment (Time Frame: 6 months)
EQ5D-5L and WHODAS 2.0 (not completed in all regions)
8 Proportion of intubated patients who receive a tracheostomy (Time Frame: Day 28)
9 Destination at time of hospital discharge (Time Frame: Free text Day 90)
Characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital
10 Readmission to the index ICU during the index hospitalization (Time Frame: Day 90 )
11 World Health Organisation 8-point ordinal scale outcome (Time Frame: Hospital discharge)
12 Days alive and not receiving organ support in ICU (Time Frame: Day 21)


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Antibiotic Domain
a.Ceftriaxone and Macrolide
b.Levofloxacin
c.Piperacillin-tazobactam and Macrolide

Interventions/Control_2

Macrolide Duration Domain:
a.Macrolide administered for 3-5 days
b.Macrolide administered for up to 14 days.

Interventions/Control_3

a.Protocolised invasive mechanical ventilation
b.Clinician-preferred invasive ventilation

Interventions/Control_4

a.Standard Care Thromboprophylaxis
b.Therapeutic anticoagulation with IV unfractionated heparin or subcutaneous low molecular weight heparin.

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

[In case of community acquired pneumonia]
1 Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with:
a. symptoms or signs or both that are consistent with lower respiratory tract infection AND
b. Radiological evidence of new onset consolidation (in patients with pre-existing radiological changes, evidence of new infiltrate)
2)Up to 48 hours after ICU admission, receiving organ support with one or more of:
a.Non-invasive or Invasive ventilatory support;
b.Receiving infusion of vasopressor or inotropes or both

[In case of COVID-19]
Adult patients hospitalized to an acute healthcare facility due to confirmed COVID-19 infection

Key exclusion criteria

[In case of community acquired pneumonia]
1. Healthcare-associated pneumonia:
a.Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
b.Resident of a nursing home or long term care facility
2. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment
3. Previous participation in this REMAP within the last 90 days

[In case of COVID-19]
1. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment
2. The patient is expected to be discharged on the day or on the following day
3. The patient has been hospitalized due to the acute illness caused by the pandemic infection for more than 14 days.
4. Previous participation in this REMAP within the last 90 days

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Shigeki
Middle name
Last name Fujitani

Organization

St. Marianna University School of Medicine

Division name

Department of Emergency and Critical Care Medicine

Zip code

216-8511

Address

2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa 216-8511 Japan

TEL

044-977-8111

Email

shigekifujitani@marianna-u.ac.jp


Public contact

Name of contact person

1st name Shigeki
Middle name
Last name Fujitani

Organization

St. Marianna University School of Medicine

Division name

Department of Emergency and Critical Care Medicine

Zip code

216-8511

Address

2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa 216-8511 Japan

TEL

044-977-8111

Homepage URL

https://www.remapcap.jp

Email

shigekifujitani@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Department of Emergency and Critical Care Medicine,

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. Marianna University School of Medicine Institutional Review Board

Address

2-16-1 Sugao Miyamae-ku, Kawasaki-shi, Kanagawa 216-8511 Japan

Tel

044-977-8111

Email

k-sienbu.mail@marianna-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

NCT02735707

Org. issuing International ID_1

clinicaltrials.gov

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

聖マリアンナ医科大学病院(神奈川県)
聖マリアンナ医科大学横浜市西部病院(神奈川県)
横浜市立大学附属病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 30 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

Terminated

Date of protocol fixation

2020 Year 11 Month 20 Day

Date of IRB

2020 Year 11 Month 30 Day

Anticipated trial start date

2021 Year 01 Month 01 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

the same registry transferred to jRCT


Management information

Registered date

2020 Year 11 Month 30 Day

Last modified on

2021 Year 09 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048462


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name