Clinical trial • Not applicable • Respiratory
Clinical trial in Community-acquired pneumonia | Respiratory tract infection
Not applicable trial for Community-acquired pneumonia | Respiratory tract infection.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Community-acquired pneumonia | Respiratory tract infection
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule | Monoclonal antibody | Other
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 09-02-2024
- First CTIS Authorization Date
- 20-03-2024
Trial design
Randomised, open-label, multiple comparator arms depending on domain, for example: no antiviral agents (no placebo); 5 days of oseltamivir; 10 days of oseltamivir; baloxavir on days 1 and 4 (weight-dependent dosing); combinations of oseltamivir + baloxavir (5- or 10-day oseltamivir courses plus baloxavir days 1 and 4); no corticosteroid; shock-dependent hydrocortisone (50 mg iv every 6 hours while in septic shock); fixed duration dexamethasone 6 mg daily for 10 days (with pregnancy-specific alternatives specified: prednisolone 40 mg or iv hydrocortisone 50 mg q6h); antibiotic comparators: ceftriaxone + macrolide; moxifloxacin or levofloxacin; piperacillin-tazobactam + macrolide; amoxicillin-clavulanate + macrolide (doses and duration determined by treating clinician or dsa guidance); endothelial domain: no endothelial modulator vs enteral imatinib (800 mg loading then 400 mg daily for days 2-14); immune modulation domain: no immune modulation vs tocilizumab (single iv dose, age/weight dependent) vs baricitinib (10-day course, dosing by age/renal function); immunoglobulin domain: no immunoglobulin vs high-titre convalescent plasma (two adult units within 48 hours). dosing details are as specified in the protocol and dsas; many doses are clinician-determined or weight-dependent per dsa.-controlled, adaptive Not applicable trial.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Multiple comparator arms depending on domain, for example: No antiviral agents (no placebo); 5 days of oseltamivir; 10 days of oseltamivir; Baloxavir on days 1 and 4 (weight-dependent dosing); combinations of oseltamivir + baloxavir (5- or 10-day oseltamivir courses plus baloxavir days 1 and 4); No corticosteroid; Shock-dependent hydrocortisone (50 mg IV every 6 hours while in septic shock); Fixed duration dexamethasone 6 mg daily for 10 days (with pregnancy-specific alternatives specified: prednisolone 40 mg or IV hydrocortisone 50 mg q6h); Antibiotic comparators: Ceftriaxone + Macrolide; Moxifloxacin or Levofloxacin; Piperacillin-tazobactam + Macrolide; Amoxicillin-clavulanate + Macrolide (doses and duration determined by treating clinician or DSA guidance); Endothelial domain: No endothelial modulator vs enteral imatinib (800 mg loading then 400 mg daily for days 2-14); Immune modulation domain: No immune modulation vs Tocilizumab (single IV dose, age/weight dependent) vs Baricitinib (10-day course, dosing by age/renal function); Immunoglobulin domain: No immunoglobulin vs high-titre convalescent plasma (two adult units within 48 hours). Dosing details are as specified in the protocol and DSAs; many doses are clinician-determined or weight-dependent per DSA.
- Adaptive
- True, the study is a randomized, embedded, multifactorial adaptive platform trial (REMAP-CAP). Interventions and domains can be opened or closed (DSMB recommendations have led to closure of specific interventions); domain-specific appendices (DSAs) govern domain rules; interim review/DSMB recommendations and stopping/closure of arms are implemented as part of the adaptive governance.
- Trial Duration For Participant
- 90
Eligibility
Recruits paediatric patients.
- Vulnerable Population
- The REMAP-CAP trial recruits patients in the ICU who are often incapacitated and unable to provide written informed consent prior to inclusion; consent by a LAR (Legally Authorized Representative) and/or delayed consent are options according to the trial protocol. Separate proxy/LAR consent forms and procedures (including telephone LAR options) are provided; re-consent by the patient is required when they regain capacity. (Source: Serious Breach description and ICF documents referenced in CTIS).
Inclusion criteria
- {"criterion_text":"- Hospitalized patient"}
- {"criterion_text":"- Acute respiratory tract infection"}
- {"criterion_text":"- Aged 28 days or older"}
- {"criterion_text":"- Domain-specific eligibility criteria are met"}
- {"criterion_text":"- The patient is eligible for at least two interventions within a domain"}
Exclusion criteria
- {"criterion_text":"- 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"}
- {"criterion_text":"- Patient is expected to be discharged from hospital within the next 24 hours"}
- {"criterion_text":"- Previous enrollment in this platform trial within the last 90 days"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint, named Survival and Recovery Trajectory, will be a composite of 90-day all-cause mortality and, among survivors, a daily ordinal scale analyzed as a trajectory of illness and recovery to 28 days.","definition_or_measurement_approach":"Composite measure: 90-day all-cause mortality and, for survivors, a daily ordinal scale representing trajectory of illness and recovery up to study day 28."}
- {"endpoint_text":"- This hierarchical ordinal scale is a composite of: • Landmark mortality at Day 90 post-randomization • Among Day-90 survivors, their daily respiratory support level as defined by position on a five-category ordinal scale: • Hospitalized on ECMO or invasive mechanical ventilation. • Hospitalized on non-invasive ventilation or high-flow oxygen. • Hospitalized on low-intensity oxygen. • Hospitalized, no oxygen. • Discharged from index hospitalization","definition_or_measurement_approach":"Hierarchical ordinal composite: primary component is mortality at Day 90; among survivors, daily categorisation of respiratory support level (5-level ordinal) tracked daily and analysed as trajectory to Day 28."}
Secondary endpoints
- {"endpoint_text":"- The generic key secondary endpoints for the trial are: • Hospital length-of-stay • Mortality censored at 90 days","definition_or_measurement_approach":"Hospital length-of-stay measured from index admission to discharge; mortality assessed and censored at 90 days post-enrolment."}
- {"endpoint_text":"- Domain-specific secondary outcomes (during the index hospitalization, censored 90 days after enrolment)","definition_or_measurement_approach":"Domain-specific measures collected during the index hospitalization and censored at 90 days after enrolment; specifics depend on domain (see Domain Specific Appendices)."}
Other endpoints
- {"endpoint_text":"- Survival, health related quality of life (HRQoL), and disability assessed after 180 days.","definition_or_measurement_approach":"Survival status, standardized HRQoL instruments and disability assessments conducted at 180 days post-enrolment."}
Recruitment
- Recruitment Window Months
- 119
- Consent Approach
- Informed consent is obtained from the patient if capable; for incapacitated patients (common in ICU) consent by a Legally Authorized Representative (LAR) and/or delayed consent are options per the protocol. The CTIS documents include multiple LAR/proxy consent forms (telephone LAR forms, proxy forms, follow-up consent forms). Sites are required to obtain patient re-consent when the patient regains capacity; country-specific requirements apply (for example, Portuguese CEIC guidance on health-care-proxy/legal representative). Subject information and ICF documents are provided in multiple language versions as indicated in the CTIS document list.
Sponsor
Primary sponsor
- Full Name
- Universitair Medisch Centrum Utrecht
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Third parties
- {"country":"Australia","full_name":"Monash University","duties_or_roles":"sponsorDuties codes present in CTIS (code: 5)","organisation_type":"Educational Institution"}
- {"country":"Croatia","full_name":"B. Synovia Ltd.","duties_or_roles":"sponsorDuties codes present in CTIS (codes: 1, 12)","organisation_type":"Health care"}
- {"country":"Italy","full_name":"Mediolanum Cardio Research S.r.l.","duties_or_roles":"sponsorDuties codes present in CTIS (codes: 1, 12)","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Sanquin Blood Supply Foundation","duties_or_roles":"Provide product","organisation_type":"Patient organisation/association"}
- {"country":"Netherlands","full_name":"Radboud Translational Medicine B.V.","duties_or_roles":"sponsorDuties codes present in CTIS (code: 4)","organisation_type":"Pharmaceutical company"}
Investigational products
- Combination Treatment
- Yes
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