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Corticosteroids and Myocardial Injury in CAP (COLOSSEUM TRIAL)

NCT03745664 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2021-09-30

No results posted yet for this 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.

Conditions

  • Community-acquired Pneumonia

Interventions

DRUG

Methylprednisolone Sodium Succinate

During hospitalization, 40 mg of methylprednisolone (20 mg/ml) will be given intravenously twice a day (20 mg every 12 hours).

DRUG

Saline Solution for Injection

During hospitalization, 2 ml of Saline Solution for Injection will be given intravenously twice a day (2 ml every 12 hours).

Sponsors & Collaborators

  • Azienda Policlinico Umberto I

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Francesco Violi, MD · University of Roma La Sapienza

  • Roberto Cangemi · University of Roma La Sapienza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-10
Primary Completion
2023-05-16
Completion
2024-09-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745664 on ClinicalTrials.gov