Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Kombinationsantibiotikabehandling for Staphylococcus Aureus-bakteriæmi (COMBAT-SAB)

23. september 2026 opdateret af: Brandon Webb, Intermountain Health Care, Inc.

COMBAT-SAB: Kombinationsantibiotikabehandling for Staphylococcus Aureus-bakteriæmi

The purpose of this study is to see if, in selected patients with a serious bacterial infection of the bloodstream, treating the bacterial infection with a combination of antibiotics is more effective than treating the infection with a single antibiotic. Participants must have blood cultures which are positive for a certain type of bacteria.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Staphyloccocus aureus bacteremia (SAB) is a common infectious disease condition in hospitalized patients which is associated with significant morbidity, excessive costs, and high mortality, despite effective antibiotic therapy. This pragmatic study is designed to test the hypothesis that outcomes in adults hospitalized with SAB will be improved by using combination antibiotic therapy (CAT) as early, targeted therapy in a high-risk subgroup. A group of patients identified early in their course as meeting at least one high-risk criterion who have no contraindications will be treated with one of two antibiotic strategies commonly used within usual care, namely: 1) antibiotic monotherapy or 2) combination antibiotic therapy, depending on the random assignment for each hospital, each month. Low-risk patients will be treated per usual care. Data from all patients admitted to participating hospitals with SAB will be included in the analysis.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

2096

Fase

  • Fase 4

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Colorado
      • Brighton, Colorado, Forenede Stater, 80601
      • Denver, Colorado, Forenede Stater, 80218
      • Grand Junction, Colorado, Forenede Stater, 81501
      • Lafayette, Colorado, Forenede Stater, 80026
      • Wheat Ridge, Colorado, Forenede Stater, 80401
    • Montana
      • Billings, Montana, Forenede Stater, 59101
      • Butte, Montana, Forenede Stater, 59701
      • Miles City, Montana, Forenede Stater, 59301
    • Utah
      • Murray, Utah, Forenede Stater, 84107
        • Rekruttering
        • Intermountain Medical Center
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Brandon J Webb, MD
      • Ogden, Utah, Forenede Stater, 84403
      • Provo, Utah, Forenede Stater, 84604
      • Salt Lake City, Utah, Forenede Stater, 84143
      • St. George, Utah, Forenede Stater, 84790

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:

  • Age ≥18 years

  • Alive and admitted to an Intermountain Health (IH) hospital acute care unit at enrollment

  • Initial positive blood culture with either methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-susceptible Staphylococcus aureus (MSSA), collected:

    1. on or during the index admission to an IH hospital, or

    2. in an ambulatory setting (laboratory, clinic or emergency department) within 48 hours of the index admission, or

    3. at a non-IH network hospital within 24 hours of subsequent transfer to an IH hospital

      Exclusion Criteria:

  • Patient requests that patient health data not be included in the analysis

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: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patients with methicillin-sensitive S. aureus bacteremia (MSSAB)

Patients with methicillin-sensitive S. aureus bacteremia (MSSAB) will be assigned to one of two different antibiotic treatment strategies appropriate for MSSA: 1) antibiotic monotherapy, or 2) combination antibiotic therapy
Medicin: Antibiotic Monotherapy (AM) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB)

Intravenous anti-staphylococcal beta-lactam, either cefazolin or nafcillin, per the discretion of the treating physician.

Medicin: Combination Antibiotic Therapy (CAT) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB)

Patients with methicillin-sensitive S. aureus bacteremia (MSSAB) and no contraindications will receive an anti-staphylococcal beta-lactam, either cefazolin or nafcillin, plus ertapenem
Eksperimentel: Patients with methicillin-resistant S. aureus bacteremia (MRSAB)

Patients with methicillin-resistant S. aureus bacteremia (MRSAB) will be assigned to one of two different antibiotic treatment strategies appropriate for MRSA: 1) antibiotic monotherapy, or 2) combination antibiotic therapy
Medicin: Antibiotic Monotherapy (AM) for patients with methicillin-resistant S. aureus bacteremia (MRSAB)

Vancomycin or daptomycin, per discretion of the treating physician

Medicin: Combination Antibiotic Therapy (CAT) for patients with methicillin-resistant S. aureus bacteremia (MRSAB)

Daptomycin plus ceftaroline

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Desirability of Outcome Ranking (DOOR)
Tidsramme: From enrollment to 30 days post enrollment

The DOOR ordinal scale includes four possible outcomes: treatment failure, infectious complications, antibiotic-associated adverse events and death. The ordinal scale comprises five levels: levels 1-4 are defined by survival at 30 days and the presence of either none, one, two or three of three possible outcomes; level 5 indicates death before 30 days. A DOOR analysis estimates the probability that overall outcomes in any given subject in one group are overall superior to those in a random subject from the other treatment group; probabilities >50% reject the null hypothesis.
From enrollment to 30 days post enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
90-day hospital-free days alive
Tidsramme: From enrollment to 90 days after enrollment

Number of days the patient is alive and out of the hospital
From enrollment to 90 days after enrollment
30-day all cause mortality
Tidsramme: From enrollment to 30 days after enrollment

Number of deaths from any cause within 30 days after enrollment
From enrollment to 30 days after enrollment
90-day all-cause mortality
Tidsramme: From enrollment to 90 days after enrollment

Number of deaths from any cause within 90 days after enrollment
From enrollment to 90 days after enrollment
30-day bacteremia-free days
Tidsramme: From enrollment to 30 days after enrollment

Number of days without bacteremia within 30 days after enrollment
From enrollment to 30 days after enrollment
Length of stay
Tidsramme: Measured at the time of hospital discharge, up to 30 days after enrollment

Number of days in the hospital following enrollment
Measured at the time of hospital discharge, up to 30 days after enrollment
Total hospital direct costs
Tidsramme: Measured at the time of hospital discharge, up to 30 days after enrollment

Total financial charges incurred by a patient during their hospitalization
Measured at the time of hospital discharge, up to 30 days after enrollment
Total inpatient antibiotic cost
Tidsramme: Measured at the time of hospital discharge, up to 30 days after enrollment

Total cost of all antibiotics received by a patient while hospitalized
Measured at the time of hospital discharge, up to 30 days after enrollment
Combination antibiotic days
Tidsramme: Measured from the time of enrollment until study day 7, death, or hospital discharge

Number of days a patient receives combination antibiotic therapy (CAT) as defined in protocol, instead of antibiotic monotherapy (AM)
Measured from the time of enrollment until study day 7, death, or hospital discharge
Antibiotic-associated adverse events
Tidsramme: From enrollment to 30 days after enrollment

Number and type of patient adverse events definitively associated with the receipt of antibiotics while hospitalized
From enrollment to 30 days after enrollment
Clostridioides difficile infection
Tidsramme: From enrollment to 30 days after hospital discharge

Presence of infection with Clostridioides difficile while hospitalized
From enrollment to 30 days after hospital discharge

Samarbejdspartnere og efterforskere

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

Sponsor

Intermountain Health Care, Inc.

Efterforskere

  • Ledende efterforsker: Brandon J Webb, MD, Intermountain Health Care, Inc.

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. februar 2026

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

21. januar 2026

Først indsendt, der opfyldte QC-kriterier

26. januar 2026

Først opslået (Faktiske)

29. januar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 1053331

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org

IPD-delingstidsramme

Data sharing will be available six months after anticipated enrollment completion, estimated August 2029, for a period to be determined by the Intermountain Office of Research and IRB

IPD-delingsadgangskriterier

Will be determined on an individual basis, upon request to the IH Office of Research.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Abonner