Antibiotic StewardshipNCT06772675
Vancomycin Reduction Practices (VRP) in the NICU
A study testing External Facilitation in people with Antibiotic Stewardship and Neonatal Sepsis, Late-Onset, run by Children's Hospital of Philadelphia at 13 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Stewardship, Neonatal Sepsis, Late-Onset, Vancomycin
- What is being tested?
- External Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 13 sitesUnited States
- Study dates
- 2 Jun 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Level III NICU
- Affiliated with Kaiser Permanente Northern California (KPNC) or Children's Hospital of Philadelphia Newborn Care Network (CNBCN)
- Recruited by study team
Who cannot join
- Site not recruited for the study
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Dr. Sagori Mukhopadhyay, 215-829-3301, mukhopadhs@chop.edu
- Recruiting
Kaiser Permanente Modesto Medical Center
Modesto, California, 95356
Dr. Michael W. Kuzniewicz, 415-279-5427, michael.w.kuzniewicz@kp.org
- Recruiting
Kaiser Permanente East Bay - Oakland Medical Center
Oakland, California, 94611
Dr. Michael W. Kuzniewicz, 415-279-5427, michael.w.kuzniewicz@kp.org
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Dr. Sagori Mukhopdhyay, 215-829-3301, mukhopadhs@chop.edu
- Recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Dr. Sagori Mukhopadhyay, 215-829-3301, mukhopadhs@chop.edu
- Recruiting
Medical Center of Princeton
Plainsboro, New Jersey, 08536
Dr. Sagori Mukhopadhyay, 215-829-3301, mukhopadhs@chop.edu
- Recruiting
Kaiser Permanente Roseville Medical Center
Roseville, California, 95661
Dr. Michael W. Kuzniewicz, 415-279-5427, michael.w.kuzniewicz@kp.org
- Recruiting
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94115
Dr. Michael W. Kuzniewicz, 415-279-5427, michael.w.kuzniewicz@kp.org
- Recruiting
Kaiser Permanente San Leandro Medical Center
San Leandro, California, 94577
Dr. Michael W. Kuzniewicz, 415-279-5427, michael.w.kuzniewicz@kp.org
- Recruiting
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, 95051
Dr. Michael W. Kuzniewicz, 415-279-5427, michael.w.kuzniewicz@kp.org
- Recruiting
Virtua Voorhees
Voorhees Township, New Jersey, 08043
Dr. Sagori Mukhopadhyay, 215-829-3301, mukhopadhs@chop.edu
- Recruiting
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, 94596
Dr. Michael W. Kuzniewicz, 415-279-5427, michael.w.kuzniewicz@kp.org
- Recruiting
Chester County Hospital
West Chester, Pennsylvania, 19380
Dr. Sagori Mukhopadhyay, 215-829-3301, mukhopadhs@chop.edu
About this study
Official title: Implementing Vancomycin Reducing Practices (VRP) in Preterm Infants
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.
- Being tested
- External Facilitation
- Keywords
- implementation study
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External FacilitationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Sites receiving external facilitation | Experimental | Sites will receive guidance from an external facilitator to support uptake of the VRP. Receives: Behavioral: External Facilitation |
| Sites not receiving external facilitation | No intervention | Sites will not receive guidance from an external facilitator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity of VRP use
Proportion of late onset sepsis (LOS) evaluations performed with high fidelity. High fidelity is defined when the evaluation follows all three core components of VRP use.
Measured: 2.5 years - From beginning of implementation phase to the end of the sustainment phase
Secondary outcomes (1)
Appropriateness/acceptability
Response to questions about whether vancomycin reducing practices (VRP) was agreeable and/or a good fit for the unit measured using validated instruments comprising of 5-point Likert scales (Weiner et al). Participants are offered options ranging from completely disagree (1) to completely agree (5), with higher scores indicating a higher degree of acceptability or feasibility.
Measured: 2.5 years - From beginning of implementation phase to the end of the sustainment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start2 Jun 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic StewardshipStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized study of external facilitation as an implementation strategy
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Sagori Mukhopadhyay, Children's Hospital of Philadelphia
- Investigators
- Sagori Mukhopadhyay, MD, MMSc, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772675
- Sponsor's protocol ID
- 24-021976
- Other IDs
- GRT-00003877
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participants here are the clinicians at the sites randomized to external facilitation. The investigators obtain survey (de-identified) and interview data from representative group of the clinicians. Since the investigators will be gathering richly detailed qualitative data that, even if de-identified of names or locations, can still be linked back to sites or individuals, the investigators will not share interview data for secondary analysis or use beyond the purposes of the proposal. The investigators will maintain de-identified (for both site and respondent identifiers) survey output that can be shared upon appropriate request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Vancomycin Reducing Practices (VRP) in Preterm Infants
- ClinicalTrials.gov ID
- NCT06772675
- Acronym / sponsor ID
- 24-021976
- Keywords
- implementation study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized study of external facilitation as an implementation strategy
| Arm | Type | Receives |
|---|---|---|
| Sites receiving external facilitation | Experimental | Behavioral: External FacilitationSites will receive guidance from an external facilitator to support uptake of the VRP. |
| Sites not receiving external facilitation | No intervention | –Sites will not receive guidance from an external facilitator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Level III NICU
- Affiliated with Kaiser Permanente Northern California (KPNC) or Children's Hospital of Philadelphia Newborn Care Network (CNBCN)
- Recruited by study team
Key exclusion criteria (1 listed)
- Site not recruited for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External FacilitationDesignated 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 | Behavioural | Sites receiving external facilitation |
Primary outcome
Fidelity of VRP use
Time frame: 2.5 years - From beginning of implementation phase to the end of the sustainment phase
Proportion of late onset sepsis (LOS) evaluations performed with high fidelity. High fidelity is defined when the evaluation follows all three core components of VRP use.
1 secondary outcome
Appropriateness/acceptability
Time frame: 2.5 years - From beginning of implementation phase to the end of the sustainment phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided. Participants here are the clinicians at the sites randomized to external facilitation. The investigators obtain survey (de-identified) and interview data from representative group of the clinicians. Since the investigators will be gathering richly detailed qualitative data that, even if de-identified of names or locations, can still be linked back to sites or individuals, the investigators will not share interview data for secondary analysis or use beyond the purposes of the proposal. The investigators will maintain de-identified (for both site and respondent identifiers) survey output that can be shared upon appropriate request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sagori Mukhopadhyay, MD, MMSc principal investigator
Children's Hospital of Philadelphia
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Facilitation in people with Antibiotic Stewardship and Neonatal Sepsis, Late-Onset, run by Children's Hospital of Philadelphia at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Gilpin (215-573-3976, kayla.gilpin@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity of VRP use (time frame: 2.5 years - From beginning of implementation phase to the end of the sustainment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.