Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)

Phase 4

Not yet recruiting

• Conditions: Community Acquired Pneumonia (CAP)
• Interventions: Drug: hydrocortisone; Drug: Methylprednisolone (drug)

• Registration Number: NCT06892197
• Lead Sponsor: Copenhagen Respiratory Research

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Study Start: 2025-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Hydrocortisone.	hydrocortisone	This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days.
Treatment with Methylprednisolone	Methylprednisolone (drug)	This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days.

Primary Outcome Measures

Name	Time	Method
All-cause mortality	30 days

Secondary Outcome Measures

Name	Time	Method
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
Daily amount of insulin administered to the patient by day 7 or discharge from hospital	7 days
Gastrointestinal bleeding	30 days
Blood glucose levels	7 days	Measured at day 3 and day 7.