Corticosteroids and Myocardial Injury in CAP (COLOSSEUM TRIAL)

NCT03745664 | Unknown Phase 3

• 1 other identifier: COLOSSEUM trial - Rif 5133
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

corticosteroids

Outcome Measures

Primary Outcomes (1)

• High sensitivity cardiac T troponin (myocardial injury biomarker)

  Primary endpoint of the study will be a significant reduction of hs-cTnT increase. Hs-cTnT will be measured . Hs-cTnT levels will be measured by the Elecsys 2010 (Roche Diagnostics, Indianapolis, IN) in a dedicated core laboratory.

  7 days

Secondary Outcomes (12)

• Serum TxB2 (biomarker of platelet activation)

  7 days

• sP-selectin (biomarker of platelet activation).

  7 days

• sCD40L (biomarker of platelet activation).

  7 days

• High-sensitivity C-Reactive Protein

  7 days

• Serum sNOX2-dp (biomarker of oxidative stress)

  7 days

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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).

Drug: Methylprednisolone Sodium Succinate

Placebo group

PLACEBO COMPARATOR

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).

Drug: Saline Solution for Injection

Interventions

Methylprednisolone Sodium Succinate DRUG

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

Treatment group

Saline Solution for Injection DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization for community-acquired pneumonia

You may not qualify if:

• Use of corticosteroids in the previous 30 days
• Health Care-Associated Pneumonia
• Reported severe immunosuppression (human immunodeficiency virus infection, immunosuppressive conditions or medications)
• Preexisting medical condition with a life expectancy of less than 3 months
• Uncontrolled diabetes mellitus
• Gastritis with or without major gastrointestinal bleeding within 3 months
• Any condition requiring acute treatment with glucocorticoids

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Azienda Policlinico Umberto I: collaborator

Study Sites (1)

Sapienza University of Rome

Rome, 00161, Italy

RECRUITING

Related Publications (4)

• Cangemi R, Casciaro M, Rossi E, Calvieri C, Bucci T, Calabrese CM, Taliani G, Falcone M, Palange P, Bertazzoni G, Farcomeni A, Grieco S, Pignatelli P, Violi F; SIXTUS Study Group; SIXTUS Study Group. Platelet activation is associated with myocardial infarction in patients with pneumonia. J Am Coll Cardiol. 2014 Nov 4;64(18):1917-25. doi: 10.1016/j.jacc.2014.07.985. Epub 2014 Oct 27.

  PMID: 25444147 BACKGROUND

• Cangemi R, Falcone M, Taliani G, Calvieri C, Tiseo G, Romiti GF, Bertazzoni G, Farcomeni A, Violi F; SIXTUS Study Group. Corticosteroid Use and Incident Myocardial Infarction in Adults Hospitalized for Community-acquired Pneumonia. Ann Am Thorac Soc. 2019 Jan;16(1):91-98. doi: 10.1513/AnnalsATS.201806-419OC.

  PMID: 30188173 BACKGROUND

• Cangemi R, Carnevale R, Nocella C, Calvieri C, Cammisotto V, Novo M, Castellani V, D'Amico A, Zerbinati C, Stefanini L, Violi F; SIXTUS Study Group. Glucocorticoids impair platelet thromboxane biosynthesis in community-acquired pneumonia. Pharmacol Res. 2018 May;131:66-74. doi: 10.1016/j.phrs.2018.03.014. Epub 2018 Mar 22.

  PMID: 29577968 BACKGROUND

• Liverani E, Banerjee S, Roberts W, Naseem KM, Perretti M. Prednisolone exerts exquisite inhibitory properties on platelet functions. Biochem Pharmacol. 2012 May 15;83(10):1364-73. doi: 10.1016/j.bcp.2012.02.006. Epub 2012 Feb 16.

  PMID: 22366284 BACKGROUND

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Methylprednisolone Hemisuccinate; Saline Solution; Injections

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Francesco Violi, MD

  University of Roma La Sapienza

  STUDY CHAIR

• Roberto Cangemi

  University of Roma La Sapienza

  STUDY DIRECTOR

Central Study Contacts

Francesco Violi, MD

CONTACT

064461933; francesco.violi@uniroma1.it

Roberto Cangemi, MD, PhD

CONTACT

3358093936; roberto.cangemi@uniroma1.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Doctors, staff and any primary care provider/s involved in the participant's non-trial management will be blinded to the group allocations. Individual participants will be not told their group allocation until the end of their involvement in the trial and after the completion of the trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Francesco Violi

Model Details: Phase 3, multicenter, double-blind, placebo-controlled, randomized, intervention trial

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 19, 2018
• Study Start: January 10, 2021
• Primary Completion: May 16, 2023
• Study Completion: September 1, 2024
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

IT (1)