Corticosteroids and Myocardial Injury in CAP (COLOSSEUM TRIAL)

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Community-acquired pneumonia (CAP) is often complicated by elevation of cardiac troponin, a marker of myocardial injury, that can be isolated or associated to myocardial infarction (MI). A retrospective study showed that corticosteroid treatment lowers incidence of MI during the hospital-stay.

The aim of this clinical trial is to examine whether in-hospital treatment with iv methylprednisolone (20 mg b.i.d) may reduce myocardial injury, as assessed by serum high-sensitivity cardiac T Troponin) and eventually cardiovascular events during a short- and long-term follow-up in patients hospitalized CAP.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Roma La Sapienza
• Collaborator: Azienda Policlinico Umberto I
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Pharmaceutical Solutions; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

Hospitalization for community-acquired pneumonia

Exclusion Criteria:

1. Use of corticosteroids in the previous 30 days

2. Health Care-Associated Pneumonia

3. Reported severe immunosuppression (human immunodeficiency virus infection, immunosuppressive conditions or medications)

4. Preexisting medical condition with a life expectancy of less than 3 months

5. Uncontrolled diabetes mellitus

6. Gastritis with or without major gastrointestinal bleeding within 3 months

7. Any condition requiring acute treatment with glucocorticoids