Hospital Avoidance Strategies for ABSSSI
Condition: Skin Infection
MeSH terms: Infections; Cellulitis; Skin Diseases, Infectious
Intervention: Dalbavancin
Intervention description: Dalbavancin, a lipoglycopeptide antibiotic, has been approved by the FDA for the treatment of ABSSSI caused by Gram-positive bacteria. A single dose of dalbavancin will be administered in the Emergency Department followed by discharge with close outpatient infectious disease clinic follow-up.
Intervention MeSH terms: Dalbavancin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be single center, randomized, non-blinded study comparing two active treatment arms to treat uncomplicated ABSSSI suspected to be due to Gram-positive bacteria:
Alternative treatment strategy comprised of a single dose of dalbavancin administered in the BJH ED or ED observation unit followed by discharge w/ close Infectious Disease outpatient clinic follow-up vs.
"Usual care" (i.e., hospital admission for intravenous antibiotics - typically, vancomycin) - antibiotic and doses to be determined at the discretion of the treating clinician (both in the BJH ED and on the BJH inpatient ward)
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute bacterial skin and skin structure infections; Hospital avoidance; Antibiotic therapy; Dalbavancin; Emergency department

Summary:

      More than 40% of patients presenting with acute bacterial skin and skin structure infection
      (ABSSSI) to the Barnes-Jewish Hospital (BJH) emergency department (ED) are admitted for
      intravenous antibiotics. There is growing evidence to suggest that many hospital admissions
      for uncomplicated ABSSSI due to Gram-positive bacteria could be avoided with an alternative
      treatment strategy employing newer long-acting antibiotics. Coupled with close outpatient
      follow-up, such an alternative hospital avoidance strategy has the potential to improve
      quality and value of care for patients with uncomplicated ABSSSI and optimize use of limited
      inpatient healthcare resources.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (age ≥18 years)

          -  Diagnosis of uncomplicated ABSSSI suspected to be due to Gram-positive bacteria by
             treating ED clinician, with presence of the following:

               1. Skin lesion size ≥75 cm2 (measured by area of erythema, edema, and/or induration)
                  AND

               2. Signs of systemic inflammation (at least 1 of the following: WBC >12,000 or
                  <4,000 cells/mm3; ≥10% immature neutrophils on peripheral smear; temperature
                  >38.3˚C or <36˚C; heart rate >90 bpm, respiratory rate >20 bpm). Signs of
                  systemic inflammation not required if the patient is age >70 years, has diabetes
                  mellitus, or has been treated with immunosuppressive or chemotherapy in the past
                  90 days.

          -  Clinical determination by treating ED clinician that patient will need hospital
             admission for the sole purpose of receiving intravenous antibiotics directed only
             towards Gram-positive bacteria (e.g., vancomycin, cefazolin) to treat uncomplicated
             ABSSSI

        Exclusion Criteria:

          -  Risk for ABSSSI due to Gram-negative bacteria (neutropenia with absolute neutrophil
             count <500 cells/µL, HIV or severely immunocompromised, burns, infection after trauma
             or as a result of an aquatic environment, infection after skin graft)

          -  Any abscess requiring bedside or operative drainage

          -  Infection due to a vascular catheter or prosthetic device

          -  Infection of a diabetic foot ulcer or decubitus ulcer

          -  Necrotizing soft tissue infection

          -  Sepsis (quick SOFA score ≥2) or septic shock (requiring vasopressors to maintain mean
             arterial pressure ≥65 mmHg despite resuscitation with at least 30mL/kg of IV
             crystalloid within first 3 hours)

          -  Recent antibiotics in prior 14 days

          -  Hypersensitivity to glycopeptides (vancomycin, televancin, dalbavancin, oritavancin)

          -  Severe renal insufficiency (CrCl <30 mL/min)

          -  Severe hepatic insufficiency (Child-Pugh Class C)

          -  Pregnant or nursing