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Kombinationsantibiotikabehandling för Staphylococcus Aureus-bakteriemi (COMBAT-SAB)

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

COMBAT-SAB: Kombinationsantibiotikabehandling för 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

2096

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Läkemedel: 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.

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

Vancomycin or daptomycin, per discretion of the treating physician

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

Daptomycin plus ceftaroline

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Desirability of Outcome Ranking (DOOR)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
90-day hospital-free days alive
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: From enrollment to 30 days after hospital discharge

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Intermountain Health Care, Inc.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2026

Primärt slutförande (Beräknad)

1 januari 2029

Avslutad studie (Beräknad)

1 januari 2029

Studieregistreringsdatum

Först inskickad

21 januari 2026

Först inskickad som uppfyllde QC-kriterierna

26 januari 2026

Första postat (Faktisk)

29 januari 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 1053331

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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