Corticosteroids and Myocardial Injury in CAP (COLOSSEUM TRIAL)

Last updated: September 28, 2021
Sponsor: University of Roma La Sapienza
Overall Status: Active - Recruiting

Phase

3

Condition

Pneumonia

Pneumonia (Pediatric)

Treatment

N/A

Clinical Study ID

NCT03745664
COLOSSEUM trial - Rif 5133
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Hospitalization for community-acquired pneumonia

Exclusion

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

Study Design

Total Participants: 122
Study Start date:
January 10, 2021
Estimated Completion Date:
September 01, 2024

Study Description

Background. 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. No data exist so far on the effect of corticosteroids on myocardial injury in CAP patients.

Study design. Double-blind randomized placebo-controlled trial. One hundred twenty-two eligible patients will be randomized to a week treatment with iv methylprednisolone (20 mg b.i.d) or placebo from hospital admission. Serum hs-cTnT will be measured at admission and every day until up 3 days from admission. ECG will be monitored every day until discharge. After dismission, all patients will be followed-up 2 years.

Aims of the study. Primary objective of the study is to evaluate if methylprednisolone is able to reduce myocardial injury, as assessed by serum high-sensitivity cardiac T Troponin (hs-cTnT), in a cohort of patients hospitalized for CAP.

Secondary aims are to evaluate the potential effect of methylprednisolone on cardiovascular events during hospitalization, at 30 day from hospital admission and during 2 years' follow-up. The trial will also examine whether the potential protective effects of methylprednisolone might be due to platelet activation down-regulation.

Connect with a study center

  • Sapienza University of Rome

    Rome, 00161
    Italy

    Active - Recruiting

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