Health TrialsbyHealthPanel

Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia

ConditionStaphylococcus Aureus Bacteremia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorIntermountain Health Care, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

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

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

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Antibiotic Monotherapy (AM) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB)

    Drug

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

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

    Drug

    Vancomycin or daptomycin, per discretion of the treating physician

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

    Drug

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

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

    Drug

    Daptomycin plus ceftaroline

Treatment groups

2,096 Participants
are divided into 2 treatment groups
Group A: Patients with methicillin-sensitive S. aureus bacteremia (MSSAB)Experimental treatment 2 interventions
Group B: Patients with methicillin-resistant S. aureus bacteremia (MRSAB)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Desirability of Outcome Ranking (DOOR)

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.

Time frame
From enrollment to 30 days post enrollment

Secondary outcomes

1

90-day hospital-free days alive

Number of days the patient is alive and out of the hospital

Time frame
From enrollment to 90 days after enrollment
2

30-day all cause mortality

Number of deaths from any cause within 30 days after enrollment

Time frame
From enrollment to 30 days after enrollment
3

90-day all-cause mortality

Number of deaths from any cause within 90 days after enrollment

Time frame
From enrollment to 90 days after enrollment
4

30-day bacteremia-free days

Number of days without bacteremia within 30 days after enrollment

Time frame
From enrollment to 30 days after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Intermountain Health Care, Inc.

Lead sponsor

Source ClinicalTrials.gov
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