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NCT Number: NCT05975671

Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta, Atlanta, Georgia, United States

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About this study

Vancomycin is among the most commonly prescribed antibiotics in United States children's hospitals, and inappropriate use of vancomycin is common. Given the high prevalence of acute kidney injury associated with vancomycin of up to 25%, reducing vancomycin overuse is a key opportunity to reduce preventable patient harm.

The primary objective of this study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care PICUs. This intervention will be informed by baseline data surrounding vancomycin use and infections due to organisms requiring vancomycin therapy which will allow selective use of vancomycin, as well as a concurrent mixed methods process and formative evaluation to inform implementation of the intervention.

During the baseline period, Electronic Health Record (EHR) data will be used to retrospectively quantify unit-level vancomycin use over 24 months (measured as vancomycin days of therapy [DOT]/1000 patient days), as well as the frequency of vancomycin use and prevalence of infections due to organisms requiring vancomycin therapy among patients with suspected and confirmed sepsis.

During the post-intervention period, which will last approximately 24 months, a multifaceted stewardship intervention to reduce vancomycin use informed by these baseline data, including:

  • The creation of a consensus guideline for vancomycin use;
  • Ad hoc education related to vancomycin overuse, and;
  • Unit-level feedback on vancomycin prescribing. The feedback on vancomycin use will be provided to clinicians at each site, both within their site (to compare to past performance) and across sites (to compare local performance to the performance of other sites).

This intervention will be locally adapted by the investigative team and sepsis stakeholders at each site. Data from the EHR will be used to assess vancomycin use (DOT/1000 patient days), as well as the secondary outcomes. Investigators will perform semi-structured interviews and repeat surveys 9 months after the implementation of the intervention. This mixed-methods process and formative evaluation will help investigators understand which elements of implementation were successful and which were not.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • Admitted to one of the participating PICUs during the study period

Patient Exclusion Criteria:

  • None

Clinician Inclusion Criteria:

  • 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
  • Age ≥ 18 years old
  • Employed by one of the participating sites

Clinician Exclusion Criteria:

  • Volunteers or other non-employee hospital staff
  • Limited English proficiency

Treatment and study plan

Multifaceted de-implementation strategy to reduce vancomycin overuse

Behavioral
  • 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.

Other names: Mixed methods intervention

Primary outcomes

  1. Change in vancomycin use

    Time frame: Baseline to 5 years

    Vancomycin use will be measured as DOT per 1000 PICU patient days, measured monthly. Every day in which one or more doses of parenteral vancomycin is administered is classified as one vancomycin DOT. Every day or portion of a day a patient is admitted to the PICU is classified as one PICU patient day.

Secondary outcomes

  1. Change in rate of suspected and confirmed sepsis episodes per 1000 PICU patient days.

    Time frame: Baseline to 5 years

    Change in the rate of suspected and confirmed sepsis episodes in which new or persistent respiratory, renal, cardiovascular, or hematologic organ dysfunction occur at day 3 and at day 7.

  2. PICU all-cause mortality

    Time frame: Up to 3 years

    All-cause mortality will be measured at 30 days following sepsis onset as a proportion of suspected and confirmed sepsis episodes. Only one episode of suspected or confirmed sepsis will be counted in this measure.

  3. PICU length of stay

    Time frame: Up to 3 years

    Time elapsed between a patient's admission into the PICU and discharge from the PICU.

  4. Hospital length of stay

    Time frame: Up to 3 years

    Time elapsed between a patient's hospital admittance and discharge.

  5. 30-day PICU readmission

    Time frame: Within 30 days of discharge from a PICU admission

    Readmission to the PICU is defined as an admission to the PICU occurring within 30 days following discharge from an admission in which there was one or more episodes of suspected or confirmed sepsis. Only one episode of suspected or confirmed sepsis will be counted in this measure. Patients without a readmission to the index hospital or health system will be counted as no readmission, due to the inability to assess readmissions to outside institutions.

  6. 30-day hospital readmission

    Time frame: Within 30 days of discharge from a hospital admission

    The percentage of patients that are readmitted to the hospital within 30 days following discharge from an admission in which there was one or more episodes of suspected or confirmed sepsis. Only one episode of suspected or confirmed sepsis will be counted in this measure.

  7. Use of other broad-spectrum antibiotics

    Time frame: Up to 5 years

    Cefepime, ceftriaxone, and piperacillin-tazobactam DOT/1000 PICU days, measured monthly (as a non-equivalent dependent variable).

  8. Use of other anti-MRSA antibiotics

    Time frame: Up to 5 years

    Linezolid, Ceftaroline, clindamycin, and trimethoprim-sulfamethoxazole in DOT/1000 patient days, measured monthly (as a balancing measure to evaluate any increase in other anti-MRSA antibiotics that may occur as an unintended consequence of reducing vancomycin use).

  9. Prevalence of infections due to organisms requiring vancomycin

    Time frame: Up to 5 years

    Microbiologic outcome measures will focus on the prevalence of vancomycin-requiring organisms in the suspected and confirmed sepsis cohorts, and will also be measured relative to the frequency of empiric vancomycin administration and compliance with the guideline.

Other outcomes

  1. Adoption of intervention

    Time frame: Onset of intervention to 2 years

    Adoption, the decision to adhere to the guideline for vancomycin use, will be measured as the proportion of sepsis episodes in which the clinician adhered to the guideline based on medical record review. Adoption will be evaluated in a 10% random sample of sepsis episodes each month by chart review.

  2. Appropriateness of intervention

    Time frame: Onset of intervention to 2 years

    Appropriateness, the perceived compatibility of the intervention to the PICU practice setting, will be measured during surveys and semi-structured interviews using the Likert Scale; where 1 = completely disagree and 5 = completely agree.

  3. Acceptability of intervention

    Time frame: Onset of intervention to 2 years

    Acceptability, how well the intervention was received by the PICU clinicians will be measured during surveys and semi-structured interviews using the Likert Scale; where 1 = completely disagree and 5 = completely agree.

  4. Measure of feasibility of intervention

    Time frame: Onset of intervention to 2 years

    Feasibility, the extent to which the intervention can be carried out in the setting, will be determined in collaboration with our local stakeholders but may include the proportion of PICU clinicians who attend educational sessions and/or unit-based meetings during which vancomycin use data is reviewed.

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Inoki, MPH

CONTACT

[email protected]

215-590-5505

Kathleen Chiotos, MD, MSCE

CONTACT

[email protected]

215-590-5505

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Children's Healthcare of Atlanta
  • Johns Hopkins University
  • St. Louis Children's Hospital
  • University of Pennsylvania

Registry information

Official study title

Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis (REVAMP-Sepsis)

Acronym: REVAMP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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