Status:
TERMINATED
Hospital Avoidance Strategies for ABSSSI
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
The Foundation for Barnes-Jewish Hospital
Allergan
Conditions:
Skin Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 antibiot...
Detailed Description
This study seeks to establish the feasibility and acceptability of an alternative treatment strategy for uncomplicated acute bacterial skin and skin structure infection (ABSSSI) in the Barnes Jewish H...
Eligibility Criteria
Inclusion
- 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:
- Skin lesion size ≥75 cm2 (measured by area of erythema, edema, and/or induration) AND
- 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
- 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
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03372941
Start Date
March 4 2019
End Date
October 14 2021
Last Update
December 9 2022
Active Locations (1)
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1
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110