Reducing unnecessary vancomycin use in children with suspected sepsis
Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis (REVAMP-Sepsis)
This study is testing a new approach to see if better guidelines and education can help doctors use less vancomycin in children suspected of having sepsis, which could lower the risk of kidney problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52500 (estimated) |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Trial ID | NCT05975671 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of a multifaceted stewardship intervention designed to reduce the use of vancomycin in pediatric intensive care units (PICUs). The intervention includes the implementation of clinical guidelines, unit-level feedback on vancomycin use, and clinician education. By analyzing electronic health record data, the study will assess vancomycin use and associated infections over a 24-month baseline period, followed by a 24-month post-intervention period. The goal is to minimize inappropriate vancomycin prescriptions and reduce the risk of acute kidney injury in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients admitted to participating PICUs with suspected sepsis.
Not a fit: Patients who are not admitted to the participating PICUs or those with confirmed infections that do not require vancomycin may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly decrease the incidence of preventable kidney injuries in children treated for suspected sepsis.
How similar studies have performed: Other studies have shown success in implementing antibiotic stewardship programs, indicating that this approach has potential for effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia and 3 other locations
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Johns Hopkins Children's Center — Baltimore, Maryland, United States (Recruiting)
- St. Louis Children's Hospital — St Louis, Missouri, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kathleen Chiotos, MD, MSCE — Children's Hospital of Philadelphia
- Study coordinator: Kathleen Chiotos, MD, MSCE
- Email: chiotosk@chop.edu
- Phone: 215-590-5505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.