Hydrocortisone vs prednisolone for severe community-acquired pneumonia

Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)

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
• Enrollment: 1600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Copenhagen Respiratory Research (Research network)
• Locations: 14 sites (Rønne, Bornholm and 13 other locations)
• Trial ID: NCT06892197 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Rønne, Bornholm and 13 other locations

• 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)
• 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

Conditions Community Acquired Pneumonia