Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis
NCT05975671 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52500
Last updated 2025-09-19
Summary
The goal of this quasi-experimental interventional study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care Pediatric Intensive Care Units (PICU).
There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include:
* Implementation of a clinical guideline indicating when vancomycin should and should not be used
* Unit-level feedback on overall vancomycin use within and across centers
* Clinician education.
Conditions
- Sepsis
- Sepsis Mrsa
- Sepsis Bacteremia
- Antimicrobial - Induced Nephropathy
- Sepsis, Severe
- Septic Shock
- Septic Syndrome
Interventions
- BEHAVIORAL
-
Multifaceted de-implementation strategy to reduce vancomycin overuse
* Clinical guidelines and group-level feedback on vancomycin use will be provided to clinicians/sepsis stakeholders at each site. * The semi-structured interviews will be performed by a trained member of the research team, under the supervision of a medical sociologist who is one of the co-investigators. A semi-structured interview guide will be used during the interviews. Interviews will be recorded and transcribed, then uploaded to a qualitative analysis software for management and coding. Names will not be recorded, and pseudonyms will be used in notes, communications about the study, and any presentations. Verbal consent will be obtained before conducting and recording the interviews. * The surveys will be performed using REDCap survey software, and participation will be voluntary. No identifiers will be collected.
Sponsors & Collaborators
-
Children's Healthcare of Atlanta
collaborator OTHER -
St. Louis Children's Hospital
collaborator OTHER - collaborator OTHER
- collaborator OTHER
-
Centers for Disease Control and Prevention
collaborator FED -
Children's Hospital of Philadelphia
lead OTHER
Principal Investigators
-
Kathleen Chiotos, MD, MSCE · children's hospital of philadelphia
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-21
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
Countries
- United States
Study Locations
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