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Kombinasjonsantibiotikabehandling for Staphylococcus Aureus-bakteriemi (COMBAT-SAB)

23. september 2026 oppdatert av: Brandon Webb, Intermountain Health Care, Inc.

COMBAT-SAB: Kombinasjonsantibiotikabehandling for Staphylococcus Aureus-bakteriemi

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

2096

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Colorado
      • Brighton, Colorado, Forente stater, 80601
        • Rekruttering
        • Platte Valley Hospital
        • Ta kontakt med:
        • Ta kontakt med:
      • Denver, Colorado, Forente stater, 80218
        • Rekruttering
        • Saint Joseph Hospital
        • Ta kontakt med:
        • Ta kontakt med:
      • Grand Junction, Colorado, Forente stater, 81501
        • Rekruttering
        • St. Mary's Regional Hospital
        • Ta kontakt med:
        • Ta kontakt med:
      • Lafayette, Colorado, Forente stater, 80026
        • Rekruttering
        • Good Samaritan Hospital
        • Ta kontakt med:
        • Ta kontakt med:
      • Wheat Ridge, Colorado, Forente stater, 80401
        • Rekruttering
        • Lutheran Medical Center
        • Ta kontakt med:
        • Ta kontakt med:
    • Montana
      • Billings, Montana, Forente stater, 59101
        • Rekruttering
        • St. Vincent Regional Hospital
        • Ta kontakt med:
        • Ta kontakt med:
      • Butte, Montana, Forente stater, 59701
      • Miles City, Montana, Forente stater, 59301
        • Rekruttering
        • Holy Rosary Hospital
        • Ta kontakt med:
        • Ta kontakt med:
    • Utah
      • Murray, Utah, Forente stater, 84107
        • Rekruttering
        • Intermountain Medical Center
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Brandon J Webb, MD
      • Ogden, Utah, Forente stater, 84403
      • Provo, Utah, Forente stater, 84604
        • Rekruttering
        • Utah Valley Hospital
        • Ta kontakt med:
        • Ta kontakt med:
      • Salt Lake City, Utah, Forente stater, 84143
      • St. George, Utah, Forente stater, 84790
        • Rekruttering
        • St. George Regional Hospital
        • Ta kontakt med:
        • 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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: 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.

Legemiddel: 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
Eksperimentell: 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
Legemiddel: Antibiotic Monotherapy (AM) for patients with methicillin-resistant S. aureus bacteremia (MRSAB)

Vancomycin or daptomycin, per discretion of the treating physician

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

Daptomycin plus ceftaroline

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Intermountain Health Care, Inc.

Etterforskere

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

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)

1. februar 2026

Primær fullføring (Antatt)

1. januar 2029

Studiet fullført (Antatt)

1. januar 2029

Datoer for studieregistrering

Først innsendt

21. januar 2026

Først innsendt som oppfylte QC-kriteriene

26. januar 2026

Først lagt ut (Faktiske)

29. januar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 1053331

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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