Effect of hydrocortisone on mortality in patients with severe community-acquired pneumonia : The REMAP-CAP Corticosteroid Domain Randomized Clinical Trial.
REMAP-CAP Investigators, Derek C Angus
https://pubmed.ncbi.nlm.nih.gov/40261382/Actively Recruiting
Led by UMC Utrecht · Updated on 2024-07-12
20000
Participants Needed
408
Research Sites
104 weeks
Total Duration
Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.
CONDITIONS
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
C
Cameron Green, MSc
S
Svenja Peters, MSc
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UMC Utrecht
Lead Sponsor
Australian and New Zealand Intensive Care Research Centre
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Investigational Trial Regimens (multiple domains) | Trial-Assigned Controls for Each Domain | Current Guideline-Based Care for Severe CAP/COVID-19 |
|---|---|---|---|
| What it is | Investigational assignment of multiple drug, biologic, and procedural interventions across randomized domains for ICU patients with severe pneumonia, influenza, and COVID-19. | Protocol-defined no-treatment or standard-of-care controls for each intervention domain; includes usual care comparators such as standard course macrolide or no corticosteroid. | Current guideline-based treatment for severe community-acquired pneumonia, influenza, or COVID-19, including empiric antibiotics, antivirals for influenza/COVID-19 where indicated, corticosteroids for severe COVID-19, and supportive care per international guidelines. |
| Role in trial | Randomized active regimens and domain-specific interventions being tested for efficacy and safety in critically ill patients. | Comparators provide controlled assessment of intervention effects by representing usual care or no-added-treatment within each domain. | Represents established practice for ICU care of pneumonia, influenza, and COVID-19 based on guideline recommendations. |
| Primary use | Evaluates impact of domain-specific interventions—including antibiotics, antivirals, corticosteroids, immune modulators, biologics, anticoagulants, vitamin C, statins, and antiplatelets—on survival and organ support requirements in critically ill patients. | Assesses comparative effectiveness of no-treatment or usual care against investigative strategies within each domain, measuring mortality, organ support-free days, and safety. | Guideline-based management seeks to optimize survival and reduce complications using established antibiotics, corticosteroids, antivirals, and supportive measures for ICU patients. |
| How it is given or performed | Drugs and interventions are administered per domain protocols, with dose, route, and duration varying by randomized allocation; some domains allow clinician discretion within specified guidelines. | Control regimens reflect either no additional treatment (e.g., no corticosteroid, no antiviral) or standard medication courses per domain; procedural care follows local standard practice. | Antibiotics, corticosteroids, and antivirals are given according to guideline-recommended dosing, route, and duration for each indication; supportive care is individualized based on patient needs. |
| Evidence status | Efficacy data for individual domain interventions is published in recent REMAP-CAP articles for hydrocortisone, vitamin C, anticoagulation, antiplatelets, IL-6 antagonists, and simvastatin; other domains are ongoing or have preliminary results. | Control regimens anchor efficacy comparisons in each domain, with published results establishing comparative effectiveness for hydrocortisone, vitamin C, anticoagulation, antiplatelets, IL-6 antagonists, and simvastatin. | Guideline-based treatment efficacy established by multiple randomized trials and meta-analyses for antibiotics, corticosteroids, and antivirals; recent REMAP-CAP publications support guideline-directed therapy in severe infection. |
| Important limitations | The factorial trial design means patients may receive several trial interventions concurrently; observed treatment effects may depend on domain interactions and underlying disease. Many investigational domains have closed or changed during the pandemic, and trial publication is ongoing for some arms. | Control arms are protocol-defined and may differ from routine practice in settings outside the trial, especially as guidelines evolve during the pandemic. Results reflect domain-specific comparisons, not head-to-head against all current-care options. | Guideline-based care recommendations may change based on evolving evidence and local context; not all interventions listed in REMAP-CAP are included in current guidelines, and access to certain agents or approaches may differ geographically. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies based on treatment domain, up to 28 days or until hospital discharge
Participants admitted to intensive care units with severe community-acquired pneumonia will receive one or more randomized treatment strategies, including various antibiotic therapies, corticosteroids, antivirals, immune modulators, anticoagulation strategies, and ventilation approaches, based on the domains they are assigned to. Treatments vary in duration and administration according to clinical guidelines and patient condition.
Daily assessments during ICU stay and hospital admission
Duration - Up to 6 months
Participants are monitored for outcomes including mortality, organ support, ICU and hospital length of stay, ventilator-free days, organ failure-free days, readmissions, and quality of life up to six months after treatment.
Scheduled follow-up visits or assessments up to 6 months post-treatment
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
18
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REMAP-CAP Investigators, Derek C Angus
https://pubmed.ncbi.nlm.nih.gov/40261382/Writing Committee for the REMAP-CAP Investigators, Lise J Estcourt, Alexis F Turgeon...
https://pubmed.ncbi.nlm.nih.gov/34606578/LOVIT-COVID Investigators, on behalf of the Canadian Critical Care Trials Group, and the REMAP-CAP Investigators, Neill K J Adhikari, Madiha Hashmi...
https://pubmed.ncbi.nlm.nih.gov/37877585/Visa Nurmi, Chanice Knight, Lise Estcourt...
https://pubmed.ncbi.nlm.nih.gov/36967714/UPMC REMAP-COVID Group, on behalf of the REMAP-CAP Investigators
https://pubmed.ncbi.nlm.nih.gov/33509275/ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators...
https://pubmed.ncbi.nlm.nih.gov/34351721/REMAP-CAP Writing Committee for the REMAP-CAP Investigators, Charlotte A Bradbury, Patrick R Lawler...
https://pubmed.ncbi.nlm.nih.gov/35315874/Yaseen M Arabi, Anthony C Gordon, Lennie P G Derde...
https://pubmed.ncbi.nlm.nih.gov/34251506/Ewan C Goligher, Patrick R Lawler, Thomas P Jensen...
https://pubmed.ncbi.nlm.nih.gov/36942550/Derek C Angus, Lennie Derde, Farah Al-Beidh...
https://pubmed.ncbi.nlm.nih.gov/32876697/UMC Utrecht
Lead Sponsor
Australian and New Zealand Intensive Care Research Centre
Collaborating Sponsor