Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)

Copenhagen Respiratory Research

Status and phase: Not yet enrolling; Phase 4

Conditions: Community Acquired Pneumonia (CAP)

Treatments: Drug: hydrocortisone; Drug: Methylprednisolone (drug)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06892197

MineraloCAP

Details and patient eligibility

About

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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,600 participants in 2 patient groups

Treatment with Hydrocortisone.

Active Comparator group

Description:

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

Treatment:

Drug: hydrocortisone

Treatment with Methylprednisolone

Active Comparator group

Description:

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

Treatment:

Drug: Methylprednisolone (drug)