Hydrocortisone vs prednisolone for severe community-acquired pneumonia
Official title: Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)
Run by Copenhagen Respiratory Research · NCT06892197 · Data updated 2026-11-12
This trial tests whether hydrocortisone or prednisolone helps adults with severe community-acquired pneumonia live longer and have fewer side effects within 30 days.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1600 (estimated) |
| Sponsor | Copenhagen Respiratory Research Research network |
| Locations | 14 sites (Rønne, Bornholm and 13 other locations) |
| Status | Recruiting |
| Started | March 10, 2026 |
| Main results expected | August 1, 2030 |
| Study ends | November 1, 2030 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT06892197 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with severe community-acquired pneumonia for whom the treating physician plans corticosteroid therapy and who can be enrolled within 24 hours of admission are ideal candidates.
✕Probably not a fit
Patients with mild pneumonia, confirmed influenza-caused pneumonia, active tuberculosis or fungal infections, those admitted more than 24 hours before enrollment, pregnant or breastfeeding women, and those intolerant to the drugs are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This cluster-randomized, phase 4 trial enrolls adults diagnosed with severe community-acquired pneumonia for whom the treating physician has decided to give corticosteroids. Participants at participating Danish hospitals are randomized to receive either hydrocortisone or prednisolone and are followed for outcomes including all-cause mortality at 30 days. Key exclusions include admission longer than 24 hours before enrollment, pregnancy or breastfeeding, active tuberculosis or fungal infection, influenza-caused pneumonia, and intolerance to the study drugs. The primary objective is to determine whether one corticosteroid leads to lower 30-day mortality or a different safety profile compared with the other.
Why it matters
Potential benefit: If successful, the trial could identify which steroid reduces 30-day mortality or causes fewer side effects, helping doctors choose the safer, more effective corticosteroid for severe CAP.
How similar studies have gone: Previous randomized trials and meta-analyses have shown that corticosteroids can reduce mortality or speed recovery in severe CAP, but direct head-to-head comparisons between hydrocortisone and prednisolone are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Diagnosis of severe CAP for who the physician in charge decides for corticosteroid therapy for severe CAP. Exclusion Criteria: * Admitted \>24 h * Pregnant or breastfeeding women * Active tuberculosis or fungal infection * Pneumonia caused by influenza * Intolerance to either study drug
Where it's running
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Bornholm Hospital
Rønne, Bornholm, Denmark Recruiting -
Amager Hospital
Copenhagen, Copenhagen City, Denmark Recruiting -
Bispebjerg Hospital
Copenhagen, Copenhagen City, Denmark Recruiting -
Frederiksberg Hospital
Frederiksberg, Copenhagen City, Denmark Recruiting -
Gentofte Hospital
Hellerup, Copenhagen City, Denmark Recruiting -
Herlev Hospital
Herlev, Copnhagen Surroundings, Denmark Recruiting
Show 8 more locations
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Hvidovre Hospital
Hvidovre, Copnhagen Surroundings, Denmark Recruiting -
Nordsjællands Hospital
Hillerød, North Zealand, Denmark Recruiting -
Holbæk Sygehus
Holbæk, Region Sjælland, Denmark Recruiting -
University Hospital of Region Zealand, Køge
Køge, Region Sjælland, Denmark Recruiting -
Næstved Sygehus
Næstved, Region Sjælland, Denmark Recruiting -
Ringsted Sygehus
Ringsted, Region Sjælland, Denmark Recruiting -
University Hospital of Region Zealand, Roskilde
Roskilde, Region Sjælland, Denmark Recruiting -
Slagelse Sygehus
Slagelse, Region Sjælland, Denmark Recruiting
Study contacts
- Study coordinator: Jens-Ulrik Stæhr Jensen, MD, PHD
- Email: jens.ulrik.jensen@regionh.dk
- Phone: 38673057
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This trial will see if a 'watch-and-wait' Safety Net Antibiotic Prescribing (SNAP) approach can safely reduce antibiotic use compared with immediate antibiotics in children aged 12 months to under 6 years with mild community-acquired pneumonia.
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ARGONAUT: Italian registry of pneumonia in people with weakened immune systems
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.