Recruiting

VancomycinReducing Empiric VAncomycin Use in Pediatric Suspected Sepsis

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT05975671

Conditions

Sepsis

Sepsis Mrsa

Sepsis Bacteremia

Antimicrobial - Induced Nephropathy

Sepsis, Severe

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Multifaceted de-implementation strategy to reduce vancomycin overuse

Study Details

Brief 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

Study ID

NCT05975671

Start date

Aug 21, 2023

Status verified date

Sep, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Patient Inclusion Criteria:

Admitted to one of the participating PICUs during the study period

Patient Exclusion Criteria:

None

Clinician Inclusion Criteria:

1. PICU prescribing clinician (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) OR sepsis stakeholder (leader of sepsis quality improvement work, medical director) at one of the participating sites at the time the survey is deployed
2. Age ≥ 18 years old
3. Employed by one of the participating sites

Clinician Exclusion Criteria:

1. Volunteers or other non-employee hospital staff
2. Limited English proficiency

Study Design

Enrollment

52500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: PICU Clinicians and Sepsis stakeholders

Clinicians and sepsis stakeholders in the participating sites will be primarily recruited via email. During the course of this multifaceted intervention:

All the PICU (Pediatric Intensive Care Unit) prescribing clinicians and sepsis stakeholders in the participating sites will receive clinical guidelines, unit-level feedback reports, and education on Vancomycin use during the intervention.
Investigators will perform semi-structured interviews with 90 PICU clinicians and sepsis stakeholders.
Surveys will be sent to all eligible clinicians, estimated to be up to 2500 individuals across the 4 sites. These structured surveys will be done at baseline and at 9 months post-implementation.

no intervention: PICU Patients with suspected sepsis

Research procedures involving patients will be limited to medical record review. This medical record review will help inform the intervention directed at PICU clinicians/stakeholders and the assessment of study outcomes. Approximately 50,000 patients will participate in the study. Data elements will be collected at each site and stored as password-protected Comma-separated values (CSV) files. These files will not contain any direct Protected Health Information (PHI) but will contain elements of date (e.g., date of admission, date of suspected sepsis episode). The study Identification (ID) number will be used to identify each unique patient. Each site will collect and store data in compliance with the Children's Hospital of Philadelphia (CHOP) and local Institutional Review Board (IRB) policies.

Interventions

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.

Primary outcome measure

Change in vancomycin use [ Time Frame: Baseline to 5 years ]

Central Contacts and Locations

Central contacts

Kathleen Chiotos, MD, MSCE

215-590-5505 chiotosk@chop.edu

Kai Inoki, MPH

215-590-5505 meyahnwid@chop.edu

Locations

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Preeti Jaggi, MD

404-727-4807 preeti.jaggi@emory.edu

Johns Hopkins Children's Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Pranita Tamma, MD, MPH

ptamma1@jhmi.edu

St. Louis Children's Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Evan Facer, DO

314-454-6050 facer@wustl.edu

Luke Starnes, PhD

314-286-2092 garys@wustl.edu

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19146

Contacts

Kathleen Chiotos, MD, MSCE

215-590-5505 chiotosk@chop.edu

Principal Investigator:

Kathleen Chiotos

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Keywords

Sepsis
Vancomycin use
methicillin-resistant Staphylococcus aureus (MRSA)
Antibiotic Stewardship
Implementation science

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2025-09-19.