Skin Infection Clinical Trial
Official title:
Hospital Avoidance Strategies for Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Verified date | November 2022 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 11 |
Est. completion date | October 14, 2021 |
Est. primary completion date | October 14, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Allergan, The Foundation for Barnes-Jewish Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Healthcare Cost Related to ABSSSI Management | Indirect/direct costs associated with ED visit(s), indirect/direct costs associated with hospital admission(s) | 28 days | |
Secondary | Clinical Response | Change in ABSSSI lesion area (cm2) | 28 days | |
Secondary | Clinical Success | Clinical resolution of symptoms, need for additional intravenous/oral antibiotic therapy | 28 days | |
Secondary | Overall Patient Satisfaction Based on Standardized Measures | Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey items | 28 days | |
Secondary | Patient Satisfaction Specific to ABSSSI Care | Targeted survey questions specific to ABSSSI and patient-centered outcomes with relation to alternative treatment strategy vs. usual care | 28 days | |
Secondary | Patient Safety | Adverse drug events | 28 days | |
Secondary | Quality of Life Measured Using RAND SF-36 Survey | RAND SF-36 | 28 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04615065 -
Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
|
||
Completed |
NCT03929224 -
The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown
|
Phase 4 | |
Enrolling by invitation |
NCT05880069 -
Clinical Outcomes in Patients With Infection by Resistant Microorganism
|
||
Completed |
NCT04239521 -
The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
|
||
Recruiting |
NCT03637400 -
Short and Long Term Outcomes of Doxycycline Versus Trimethoprim-Sulfamethoxazole for Skin and Soft Tissue Infections Treatment
|
Phase 2 | |
Completed |
NCT06149117 -
Bioequivalence Study of Azithromycin Capsule and Reference Formulation Sumamed * in Healthy Adult Subjects in China
|
Phase 4 | |
Active, not recruiting |
NCT05226260 -
Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care
|
N/A | |
Recruiting |
NCT03131843 -
Effectiveness of Alcohol Swabs for Preventing Infections During Vaccination
|
Phase 3 | |
Recruiting |
NCT04278404 -
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
|
||
Completed |
NCT02512614 -
Evaluation of Novel Antimicrobial Hand Towels
|
Phase 2/Phase 3 | |
Completed |
NCT01593761 -
Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
|
Phase 2 | |
Not yet recruiting |
NCT06247761 -
STASSH - TRAUMA - Absorbable vs Non-Absorbable Sutures in Trauma Hand Surgery
|
N/A | |
Not yet recruiting |
NCT06170983 -
Skin Inflammation and PK of Azithromycin
|
N/A | |
Completed |
NCT02052388 -
Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections
|
Phase 2 | |
Completed |
NCT00619710 -
Complicated Skin and Skin Structure Infections
|
Phase 3 | |
Recruiting |
NCT05339802 -
A Phase Ⅱ Clinical Study of 9MW1411 Injection in Acute Bacterial Skin and Skin Structure Infections
|
Phase 2 | |
Completed |
NCT06087809 -
Improving Short Course Treatment for Common Pediatric Infections
|
N/A | |
Not yet recruiting |
NCT05899140 -
Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial
|
Phase 4 |