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Corticosteroids and Myocardial Injury in CAP (COLOSSEUM TRIAL) (COLOSSEUM)

28. september 2021 oppdatert av: Francesco Violi, University of Roma La Sapienza

Effect of Corticosteroids On MyocardiaL Injury Among Patients Hospitalized for Community-AcquirEd PneUMonia - COLOSSEUM TRIAL

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

122

Fase

  • Fase 3

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Italia
      • Rome, Italia, 00161
        • Rekruttering
        • Sapienza University of Rome
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Treatment group

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).
Legemiddel: Methylprednisolone Sodium Succinate
During hospitalization, 40 mg of methylprednisolone (20 mg/ml) will be given intravenously twice a day (20 mg every 12 hours).
Placebo komparator: Placebo group
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).
Legemiddel: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
High sensitivity cardiac T troponin (myocardial injury biomarker)
Tidsramme: 7 days
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serum TxB2 (biomarker of platelet activation)
Tidsramme: 7 days
Serum Thromboxane (Tx) B2 will be measured on blood samples obtained at admission, after 72 hours and at hospital discharge (within 7 days).
7 days
sP-selectin (biomarker of platelet activation).
Tidsramme: 7 days
Plasma sP-selectin will be measured on blood samples obtained at admission, after 72 hours and at hospital discharge (within 7 days).
7 days
sCD40L (biomarker of platelet activation).
Tidsramme: 7 days
Plasma sCD40L will be measured on blood sample obtained at admission, after 72 hours and at hospital discharge (within 7 days).
7 days
High-sensitivity C-Reactive Protein
Tidsramme: 7 days
Serum high-sensitivity C-Reactive Protein will be measured in blood samples obtained at admission, after 72 hours and at hospital discharge (within 7 days).
7 days
Serum sNOX2-dp (biomarker of oxidative stress)
Tidsramme: 7 days
Serum sNOX2-dp will be measured on blood samples obtained at admission, after 72 hours and at hospital discharge (within 7 days). Blood levels of soluble NOX2-derived peptide (sNOX2-dp), a marker of NADPH oxidase activation, will be detected by ELISA as previously described (Pignatelli P et al Arterioscler Thromb Vasc Biol 2010;30:360-7).
7 days
Serum F2-isoprostanes (biomarker of oxidative stress)
Tidsramme: 7 days
Serum F2-isoprostane (8-iso-PGF2α -III) will be measured by the enzyme immunoassay method in blood samples obtained at admission, after 72 horus and at hospital discharge (within 7 days).
7 days
Urinary F2-isoprostanes (biomarker of oxidative stress)
Tidsramme: 7 days
F2-isoprostanes will be measured in urine samples collected at admission, after 72 horus and at hospital discharge (within 7 days).
7 days
Cardiovascular events during hospitalization.
Tidsramme: 7 days
This composite outcome will consist in any of the following events during hospitalization: acute myocardial infarction, new or worsening heart failure, new onset atrial fibrillation, stroke, cardiovascular death.
7 days
Major adverse cardiac and cerebrovascular events (MACCE) at 30 days.
Tidsramme: 30 days
This composite outcome will consist in any of the following events during a 30-days follow-up: cardiovascular death, myocardial infarction and stroke.
30 days
Major adverse cardiac and cerebrovascular events (MACCE) during a a long-term follow-up.
Tidsramme: 2 years
This composite outcome will consist in any of the following events during a 2-years f follow-up: cardiovascular death, myocardial infarction and stroke.
2 years
Short-term mortality
Tidsramme: 30 days
Death for any cause during a 30-days follow-up
30 days
Long-term mortality
Tidsramme: 2 years
Death for any cause during a2 years follow-up
2 years

Samarbeidspartnere og etterforskere

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Sponsor

University of Roma La Sapienza

Samarbeidspartnere

Azienda Policlinico Umberto I

Etterforskere

  • Studiestol: Francesco Violi, MD, University of Roma La Sapienza
  • Studieleder: Roberto Cangemi, University of Roma La Sapienza

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. januar 2021

Primær fullføring (Forventet)

16. mai 2023

Studiet fullført (Forventet)

1. september 2024

Datoer for studieregistrering

Først innsendt

14. november 2018

Først innsendt som oppfylte QC-kriteriene

16. november 2018

Først lagt ut (Faktiske)

19. november 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. september 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. september 2021

Sist bekreftet

1. september 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • COLOSSEUM trial - Rif 5133

Plan for individuelle deltakerdata (IPD)

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produkt produsert i og eksportert fra USA

Nei

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