Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis

NCT05975671 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52500

Last updated 2025-09-19

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975671 on ClinicalTrials.gov