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Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)

ConditionCommunity Acquired Pneumonia (CAP)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCopenhagen Respiratory Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Diagnosis of severe CAP for who the physician in charge decides for corticosteroid therapy for severe CAP.

Disqualifiers

Admitted >24 h

Pregnant or breastfeeding women

Active tuberculosis or fungal infection

Pneumonia caused by influenza

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,600 Participants
are divided into 2 treatment groups
Group A: Treatment with Hydrocortisone.Active comparator 1 intervention
Group B: Treatment with MethylprednisoloneActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Copenhagen Respiratory Research

Lead sponsor

Source ClinicalTrials.gov
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