Corticosteroids and Myocardial Injury in CAP (COLOSSEUM TRIAL)

University of Roma La Sapienza

Status and phase: Enrolling; Phase 3

Conditions: Community-acquired Pneumonia

Treatments: Drug: Methylprednisolone Sodium Succinate; Drug: Saline Solution for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03745664

COLOSSEUM trial - Rif 5133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups, including a placebo group

Treatment group

Active Comparator group

Description:

Methylprednisolone Sodium Succinate (20mg/ml) will be given at the dose of 40 mg/day (20 mg x 2/day). The treatment will last 7 days (or the time of hospitalization if the patient is discharged in a period less or more than 7 days).

Treatment:

Drug: Methylprednisolone Sodium Succinate

Placebo group

Placebo Comparator group

Description:

Saline Solution for Injection will be given ath the dose of 2 ml/day. The treatment placebo will last 7 days (or the time of hospitalization if the patient is discharged in a period less or more than 7 days).

Treatment:

Drug: Saline Solution for Injection