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

JRCT ID: jRCT1031210150

Registered date:14/06/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Community-acquired pneumonia and COVID-19 infection
• Date of first enrollment: 14/06/2021
• Target sample size: 500
• Countries of recruitment: Australia,Japan,New Zealand,Japan,European,Japan,Canada,Japan,Saudi Arabia,Japan,United States of America,Japan
• Study type: Interventional

Intervention(s)

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

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

[Mechanical Ventilation Acute Respiratory Failure Domain]
a.Protocolised invasive mechanical ventilation
b.Clinician-preferred invasive ventilation

[COVID-19 Anticoagulation Domain]
a.Conventional low dose thromboprophylaxis
b.Intermediate dose thromboprophylaxis
c.Continuation of therapeutic dose anticoagulation (only in the Prior Therapeutic Anticoagulation Stratum)

Outcome(s)

• Primary Outcome: All-cause mortality (Time Frame: Day 90)

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Fujitani Shigeki
• Secondary Sponsor: Ichihara Nao
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development