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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042594
Receipt No. 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 2020/12/01

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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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
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
Institute St. Marianna University School of Medicine

Department of Emergency and Critical Care Medicine,
Institute
Department

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

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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 20 Day
Date of IRB
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

Management information
Registered date
2020 Year 11 Month 30 Day
Last modified on
2020 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.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


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