Recruiting

Vancomycin Reduction Practices

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT06772675

Conditions

Antibiotic Stewardship

Neonatal Sepsis, Late-Onset

Vancomycin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

External Facilitation

Study Details

Brief summary:

This multi-center, cluster randomized study aimed at improving implementation of vancomycin reducing practices (VRP) in neonatal intensive care units (NICUs). Sites will be recruited and randomized to receive either external facilitation or no external facilitation to assess the effect on center-level fidelity to the core components of VRP implementation. Interventions available to both study arms are directed at hospital staff and includes identification of local champions, educational outreach, unit-level audit \& feedback, and use of a clinical decision support tool.

Conditions

Antibiotic Stewardship

Neonatal Sepsis, Late-Onset

Vancomycin

Study ID

NCT06772675

Start date

Jun 2, 2025

Status verified date

Jun, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Level III NICU
  • Affiliated with Kaiser Permanente Northern California (KPNC) or Children's Hospital of Philadelphia Newborn Care Network (CNBCN)
  • Recruited by study team

Exclusion Criteria:

  • Site not recruited for the study

Study Design

Enrollment

13 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Sites receiving external facilitation

Sites will receive guidance from an external facilitator to support uptake of the VRP.

no intervention: Sites not receiving external facilitation

Sites will not receive guidance from an external facilitator.

Interventions

External Facilitation

Designated external facilitators will conduct monthly meetings with local champions at each site. Designated facilitators will follow the developed facilitation guide, that includes content area to cover in each meeting, case scenarios as examples, and tips on how to communicate and support the internal facilitators. The goal is to enable problem-solving and support the local champion in implementing VRP with fidelity

Primary outcome measure

  • Fidelity of VRP use [ Time Frame: 2.5 years - From beginning of implementation phase to the end of the sustainment phase ]

Central Contacts and Locations

Central contacts

Kayla Gilpin

215-573-3976kayla.gilpin@pennmedicine.upenn.edu

Morgan Gabbert

267-233-3150gabbertm@chop.edu

Locations

Kaiser Permanente Modesto Medical Center

Recruiting

Modesto, California, United States, 95356

Contacts

Dr. Michael W. Kuzniewicz

415-279-5427michael.w.kuzniewicz@kp.org

Kaiser Permanente East Bay - Oakland Medical Center

Recruiting

Oakland, California, United States, 94611

Contacts

Dr. Michael W. Kuzniewicz

415-279-5427michael.w.kuzniewicz@kp.org

Kaiser Permanente Roseville Medical Center

Recruiting

Roseville, California, United States, 95661

Contacts

Dr. Michael W. Kuzniewicz

415-279-5427michael.w.kuzniewicz@kp.org

Kaiser Permanente San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94115

Contacts

Dr. Michael W. Kuzniewicz

415-279-5427michael.w.kuzniewicz@kp.org

Kaiser Permanente San Leandro Medical Center

Recruiting

San Leandro, California, United States, 94577

Contacts

Dr. Michael W. Kuzniewicz

415-279-5427michael.w.kuzniewicz@kp.org

Kaiser Permanente Santa Clara Medical Center

Recruiting

Santa Clara, California, United States, 95051

Contacts

Dr. Michael W. Kuzniewicz

415-279-5427michael.w.kuzniewicz@kp.org

Kaiser Permanente Walnut Creek Medical Center

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Dr. Michael W. Kuzniewicz

415-279-5427michael.w.kuzniewicz@kp.org

Medical Center of Princeton

Recruiting

Plainsboro, New Jersey, United States, 08536

Contacts

Dr. Sagori Mukhopadhyay

215-829-3301mukhopadhs@chop.edu

Virtua Voorhees

Recruiting

Voorhees Township, New Jersey, United States, 08043

Contacts

Dr. Sagori Mukhopadhyay

215-829-3301mukhopadhs@chop.edu

Lancaster General Hospital

Recruiting

Lancaster, Pennsylvania, United States, 17602

Contacts

Dr. Sagori Mukhopadhyay

215-829-3301mukhopadhs@chop.edu

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Dr. Sagori Mukhopdhyay

215-829-3301mukhopadhs@chop.edu

Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Dr. Sagori Mukhopadhyay

215-829-3301mukhopadhs@chop.edu

Chester County Hospital

Recruiting

West Chester, Pennsylvania, United States, 19380

Contacts

Dr. Sagori Mukhopadhyay

215-829-3301mukhopadhs@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Dec 24, 2025

Last verified

Jun, 2025

Keywords

  • implementation study

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 2025-12-24.