UMIN-CTR Clinical Trial

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

Community-acquired pneumonia

Classification by specialty

Pneumology	Infectious disease	Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Factorial

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

St. Marianna University School of Medicine

Department of Emergency and Critical Care Medicine,

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

YES

Study ID_1

NCT02735707

Org. issuing International ID_1

clinicaltrials.gov

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2020

Year

11

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

the same registry transferred to jRCT

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