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NCT Number: NCT06892197

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.

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Key information

Conditions

Community Acquired Pneumonia (CAP) Community-Acquired Infections Community-Acquired Pneumonia Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bornholm Hospital, Rønne, Bornholm, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone (drug)

Drug

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

Hydrocortisone

Drug

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

Primary outcomes

  1. All-cause mortality

    Time frame: 30 days

Secondary outcomes

  1. All-cause mortality

    Time frame: 90 days

  2. All-cause infections

    Time frame: 90 days

  3. Need for vasopressor treatment

    Time frame: 30 days

  4. Need for mechanical ventilation

    Time frame: 30 days

  5. Admission to ICU

    Time frame: 30 days

  6. Daily amount of insulin administered to the patient by day 7 or discharge from hospital

    Time frame: 7 days

  7. Gastrointestinal bleeding

    Time frame: 30 days

  8. Blood glucose levels

    Time frame: 7 days

    Measured at day 3 and day 7.

Study contacts

Contact information is provided by the study sponsor or research team.

Jens-Ulrik Stæhr Jensen, MD, PHD

CONTACT

[email protected]

38673057 ext. +45

Pradeesh Sivapalan, MD, PHD

CONTACT

[email protected]

29880601 ext. +45

Sponsors and collaborators

Lead sponsor

Copenhagen Respiratory Research

Network

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 24, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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