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Recruiting Phase 4 NCT06892197

NCT06892197 Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)

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Clinical Trial Summary
NCT ID NCT06892197
Status Recruiting
Phase Phase 4
Sponsor Copenhagen Respiratory Research
Condition Community Acquired Pneumonia (CAP)
Study Type INTERVENTIONAL
Enrollment 1,600 participants
Start Date 2026-03-10
Primary Completion 2030-08-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Methylprednisolone (drug)hydrocortisone

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 1,600 participants in total. It began in 2026-03-10 with a primary completion date of 2030-08-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The goal of this cluster randomized controlled trial is to determine the optimal treatment for community aquired pneumonia (CAP). The study compares the effects and side effects of hydrocortisone and prednisolone in patients above 18 years old diagnosed with severe CAP. The main question is whether there is a difference in all cause mortality within thirty days. Participants will be randomized to receive treatment with either hydrocortisone or prednisolone.

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

Contact & Investigator

Central Contact

Jens-Ulrik Stæhr Jensen, MD, PHD

✉ jens.ulrik.jensen@regionh.dk

📞 38673057

Principal Investigator

Jens-Ulrik Stæhr Jensen, MD, PHD

STUDY DIRECTOR

COP:RESP

Frequently Asked Questions

Who can join the NCT06892197 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Community Acquired Pneumonia (CAP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06892197 trial and what does that mean for participants?

Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.

Is NCT06892197 currently recruiting?

Yes, NCT06892197 is actively recruiting participants. Contact the research team at jens.ulrik.jensen@regionh.dk for enrollment information.

Where is the NCT06892197 trial being conducted?

This trial is being conducted at Rønne, Denmark, Copenhagen, Denmark, Copenhagen, Denmark, Frederiksberg, Denmark and 10 additional locations.

Who is sponsoring the NCT06892197 clinical trial?

NCT06892197 is sponsored by Copenhagen Respiratory Research. The principal investigator is Jens-Ulrik Stæhr Jensen, MD, PHD at COP:RESP. The trial plans to enroll 1,600 participants.

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