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Statin Therapy in Acute Influenza

25. juli 2019 opdateret af: Maureen Chase MD MPH, Principal Investigator, Beth Israel Deaconess Medical Center
Influenza (the 'flu') is a common virus infecting approximately 5-20% of the population in the United States and causing as many as 500,000 deaths worldwide each year. Currently, there are only a few treatments for influenza infection and none of these target inflammation that can be caused by the virus. This study will test whether the anti-inflammatory effects of statins, a class of drugs most often used to treat high cholesterol, will decrease the severity of illness in patients who are infected with influenza by testing markers of inflammation in the blood and recording resolution of influenza illness.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

116

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • The Beth Israel Deaconess Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:(all must be present):

  1. Adult patient (age > 18 years)
  2. Positive influenza DFA/RAT test result
  3. <12 hours from positive influenza test result

Exclusion Criteria:

  1. Prior statin medication use (within 30 days of positive influenza test result)
  2. Comfort measures only designation or anticipated withdrawal of life-support

  3. Atorvastatin specific exclusions:

    1. Documented liver cirrhosis or liver dysfunction (AST or ALT greater than 240)
    2. Known allergy or intolerance to statins
    3. Rhabdomyolysis (CPK elevation > 6x normal)
    4. Patients taking the following medications: cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole) clarithromycin and colchicine
  4. Patients unable to take oral or nasogastric medications or plan for no oral intake as part of medical course (eg. emergent surgical intervention)
  5. Known pregnancy or active breastfeeding
  6. Inability to provide written informed consent for any reason

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Atorvastatin
Patients will be administered study medication (atorvastatin 40 mg) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.
Medicin: Atorvastatin
Andre navne:
  • Lipitor
Placebo komparator: Placebo
Patients will be administered study medication (matched placebo) orally once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.
Medicin: Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Inflammatory Markers From Time Zero to 72 Hours
Tidsramme: Baseline to 72 hours
The primary IL- 6 measurements were at time zero and at 72 hours. Analysis was performed using a linear mixed effects model to make use of all biomarker timepoints as hospitalized patients had biomarkers measured at additional timepoints.
Baseline to 72 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Severity of Illness Score Baseline to 72 Hours
Tidsramme: Baseline and 72 hours
Composite score for 5 major symptoms (fever, cough, sore throat, headache, myalgia) ranked from 0 to 3 (none, mild, moderate, severe) for a score ranging from 0 to 15. Higher scores reflect more severe symptoms.
Baseline and 72 hours

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression to Shock State
Tidsramme: From date of randomization until discharge from hospital
The investigators will assess the effect of statin therapy on rates of development of shock state
From date of randomization until discharge from hospital
Severity of Illness
Tidsramme: 24 hours post enrollment
The investigators will assess the effect of statin therapy on APACHE II scores
24 hours post enrollment
In-hospital Mortality
Tidsramme: From date of randomization until the date of first documented discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 year
The investigators will assess the effect of statin therapy on in-hospital mortality
From date of randomization until the date of first documented discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 year
ICU and Hospital Length of Stay
Tidsramme: From date of randomization until the date of ICU discharge (in the event of ICU admission) and/or hospital discharge, based on an estimated average of 30 days
The investigators will assess the effect of statin therapy on hospital and ICU length of stay.
From date of randomization until the date of ICU discharge (in the event of ICU admission) and/or hospital discharge, based on an estimated average of 30 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beth Israel Deaconess Medical Center

Samarbejdspartnere

National Institute of General Medical Sciences (NIGMS)

Efterforskere

  • Ledende efterforsker: Maureen Chase, MD, MPH, Beth Israel Deaconess Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2013

Primær færdiggørelse (Faktiske)

30. juni 2018

Studieafslutning (Faktiske)

30. juni 2018

Datoer for studieregistrering

Først indsendt

15. oktober 2013

Først indsendt, der opfyldte QC-kriterier

4. februar 2014

Først opslået (Skøn)

6. februar 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2013P000026
  • 1K23GM101463-01A1 (U.S. NIH-bevilling/kontrakt)
  • FWA00003245 (Anden identifikator: BIDMC)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Influenza

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

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