Hospital Avoidance Strategies for ABSSSI

NCT03372941 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 201709136
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Skin Infection

Keywords

Acute bacterial skin and skin structure infections; Hospital avoidance; Antibiotic therapy; Dalbavancin; Emergency department

Outcome Measures

Primary Outcomes (1)

• Healthcare Utilization Related to ABSSSI

  Repeat ED visit(s) within 28 days, need for hospital admission(s) to receive intravenous antibiotics ("alternative treatment strategy" arm), or need for switch to different oral or intravenous antibiotic to treat ABSSSI ("usual care" arm)

  28 days

Secondary Outcomes (7)

• Healthcare Cost Related to ABSSSI Management

  28 days

• Clinical Response

  28 days

• Clinical Success

  28 days

• Overall Patient Satisfaction Based on Standardized Measures

  28 days

• Patient Satisfaction Specific to ABSSSI Care

  28 days

Study Arms (2)

Alternative treatment strategy

ACTIVE COMPARATOR

Patient will receive a single dose of dalbavancin administered in the BJH ED or ED observation unit for ABSSSI followed by discharge w/ close Infectious Disease outpatient clinic follow-up.

Drug: Dalbavancin

Usual care

NO INTERVENTION

Patients will receive "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).

Interventions

Dalbavancin DRUG

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.

Also known as: Dalvance

Alternative treatment strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Foundation for Barnes-Jewish Hospital: collaborator
• Allergan: collaborator

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Cellulitis; Emergencies

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Results Point of Contact

• Title: Stephen Liang
• Organization: Washington University School of Medicine

syliang@wustl.edu

3017470750

Study Officials

• Stephen Y Liang, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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)

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 14, 2017
• Study Start: March 4, 2019
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: December 9, 2022
• Results First Posted: December 9, 2022

Record last verified: 2022-11

Locations

US (1)