Hospital Avoidance Strategies for ABSSSI

• Status: Terminated
• Trial end date: 2021-10-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Allergan; The Foundation for Barnes-Jewish Hospital
• Treatments: Dalbavancin

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