Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)

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.

Study Overview

• Status: Recruiting
• Conditions: Community Acquired Pneumonia (CAP)
• Intervention / Treatment: Drug: hydrocortisone; Drug: Methylprednisolone (drug)

• Study Type: Interventional
• Enrollment (Estimated): 1600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jens-Ulrik Stæhr Jensen, MD, PHD; Phone Number: +45 38673057; Email: jens.ulrik.jensen@regionh.dk
• Study Contact Backup: Name: Pradeesh Sivapalan, MD, PHD; Phone Number: +45 29880601; Email: pradeesh.sivapalan.02@regionh.dk

Study Locations

• Denmark
  • Bornholm
    • Rønne, Bornholm, Denmark, 3700
      • Recruiting
      • Bornholm Hospital
  • Copenhagen City
    • Copenhagen, Copenhagen City, Denmark, 2300
      • Recruiting
      • Amager Hospital
    • Copenhagen, Copenhagen City, Denmark, 2400
      • Recruiting
      • Bispebjerg Hospital
    • Frederiksberg, Copenhagen City, Denmark, 2000
      • Recruiting
      • Frederiksberg Hospital
    • Hellerup, Copenhagen City, Denmark, 2900
      • Recruiting
      • Gentofte Hospital
  • Copnhagen Surroundings
    • Herlev, Copnhagen Surroundings, Denmark, 2730
      • Recruiting
      • Herlev Hospital
    • Hvidovre, Copnhagen Surroundings, Denmark, 2650
      • Recruiting
      • Hvidovre Hospital
  • North Zealand
    • Hillerød, North Zealand, Denmark, 3400
      • Recruiting
      • Nordsjællands Hospital
  • Region Sjælland
    • Holbæk, Region Sjælland, Denmark, 4300
      • Recruiting
      • Holbæk Sygehus
    • Køge, Region Sjælland, Denmark, 4600
      • Recruiting
      • University Hospital of Region Zealand, Køge
    • Næstved, Region Sjælland, Denmark, 4700
      • Recruiting
      • Næstved Sygehus
    • Ringsted, Region Sjælland, Denmark, 4100
      • Recruiting
      • Ringsted Sygehus
    • Roskilde, Region Sjælland, Denmark, 4000
      • Recruiting
      • University Hospital of Region Zealand, Roskilde
    • Slagelse, Region Sjælland, Denmark, 4200
      • Recruiting
      • Slagelse Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment with Hydrocortisone.; This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days.	Drug: hydrocortisone; ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate.
Active Comparator: Treatment with Methylprednisolone; This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days.	Drug: Methylprednisolone (drug); ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		90 days
Need for mechanical ventilation		30 days
Daily amount of insulin administered to the patient by day 7 or discharge from hospital		7 days
Gastrointestinal bleeding		30 days
All-cause infections		90 days
Need for vasopressor treatment		30 days
Admission to ICU		30 days
Blood glucose levels	Measured at day 3 and day 7.	7 days

Collaborators and Investigators

• Sponsor: Copenhagen Respiratory Research
• Investigators: Study Director: Jens-Ulrik Stæhr Jensen, MD, PHD, COP:RESP

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Pneumonia; Community-Acquired Infections; Community-Acquired Pneumonia; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; 17-Hydroxycorticosteroids; Prednisolone; Methylprednisolone; Hydrocortisone; Pharmaceutical Preparations
• Other Study ID Numbers: MineraloCAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This has not yet been decided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No