Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)

NCT06892197 | Recruiting Phase 4 DMC

• 1 other identifier: MineraloCAP
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 14

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.

Conditions

Community Acquired Pneumonia (CAP)

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  30 days

Secondary Outcomes (8)

• All-cause mortality

  90 days

• All-cause infections

  90 days

• Need for vasopressor treatment

  30 days

• Need for mechanical ventilation

  30 days

• Admission to ICU

  30 days

Study Arms (2)

Treatment with Hydrocortisone.

ACTIVE COMPARATOR

This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days.

Drug: hydrocortisone

Treatment with Methylprednisolone

ACTIVE COMPARATOR

This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days.

Drug: Methylprednisolone (drug)

Interventions

Methylprednisolone (drug) DRUG

ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally.

Treatment with Methylprednisolone

hydrocortisone DRUG

ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate.

Treatment with Hydrocortisone.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Diagnosis of severe CAP for who the physician in charge decides for corticosteroid therapy for severe CAP.

You may not qualify if:

• Admitted \>24 h
• Pregnant or breastfeeding women
• Active tuberculosis or fungal infection
• Pneumonia caused by influenza
• Intolerance to either study drug

Sponsors & Collaborators

• Copenhagen Respiratory Research: lead

Study Sites (14)

Bornholm Hospital

Rønne, Bornholm, 3700, Denmark

RECRUITING

Amager Hospital

Copenhagen, Copenhagen City, 2300, Denmark

RECRUITING

Bispebjerg Hospital

Copenhagen, Copenhagen City, 2400, Denmark

RECRUITING

Frederiksberg Hospital

Frederiksberg, Copenhagen City, 2000, Denmark

RECRUITING

Gentofte Hospital

Hellerup, Copenhagen City, 2900, Denmark

RECRUITING

Herlev Hospital

Herlev, Copnhagen Surroundings, 2730, Denmark

RECRUITING

Hvidovre Hospital

Hvidovre, Copnhagen Surroundings, 2650, Denmark

RECRUITING

Nordsjællands Hospital

Hillerød, North Zealand, 3400, Denmark

RECRUITING

Holbæk Sygehus

Holbæk, Region Sjælland, 4300, Denmark

RECRUITING

University Hospital of Region Zealand, Køge

Køge, Region Sjælland, 4600, Denmark

RECRUITING

Næstved Sygehus

Næstved, Region Sjælland, 4700, Denmark

RECRUITING

Ringsted Sygehus

Ringsted, Region Sjælland, 4100, Denmark

RECRUITING

University Hospital of Region Zealand, Roskilde

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

Slagelse Sygehus

Slagelse, Region Sjælland, 4200, Denmark

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Methylprednisolone; Pharmaceutical Preparations; Hydrocortisone

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Jens-Ulrik Stæhr Jensen, MD, PHD

  COP:RESP

  STUDY DIRECTOR

Central Study Contacts

Jens-Ulrik Stæhr Jensen, MD, PHD

CONTACT

38673057; jens.ulrik.jensen@regionh.dk

Pradeesh Sivapalan, MD, PHD

CONTACT

29880601; pradeesh.sivapalan.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The study is a cluster randomized controlled trial. It consists of two arms, in which patients will be randomized to receive treatment with either Hydrocortisone or Prednisolone.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: March 10, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

DK (14)