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Antibiotic Stewardship Strategy for Sepsis (REVAMP Trial)
N/A
Recruiting
Led By Kathleen Chiotos, MD, MSCE
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
REVAMP Trial Summary
This trial will evaluate if a multifaceted stewardship intervention can reduce the use of a powerful antibiotic (vancomycin) in pediatric intensive care units.
Who is the study for?
This trial is for pediatric patients admitted to participating Pediatric Intensive Care Units (PICUs) during the study period. It aims to see if a new strategy can reduce unnecessary use of vancomycin, an antibiotic that treats serious infections.Check my eligibility
What is being tested?
The study tests a de-implementation strategy including clinical guidelines on proper vancomycin use, feedback on its usage rates in PICUs, and clinician education. The goal is to lower overuse without compromising patient care.See study design
What are the potential side effects?
While this trial focuses on reducing vancomycin use rather than direct side effects, potential risks may include less protection against infection if used improperly and kidney issues from overuse.
REVAMP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in vancomycin use
Secondary outcome measures
30-day PICU readmission
30-day hospital readmission
Change in rate of suspected and confirmed sepsis episodes per 1000 PICU patient days.
+6 moreOther outcome measures
Acceptability of intervention
Adoption of intervention
Appropriateness of intervention
+1 moreREVAMP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PICU Clinicians and Sepsis stakeholdersExperimental Treatment1 Intervention
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.
Group II: PICU Patients with suspected sepsisActive Control1 Intervention
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.
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Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,530,520 Total Patients Enrolled
5 Trials studying Sepsis
9,268 Patients Enrolled for Sepsis
Children's Healthcare of AtlantaOTHER
165 Previous Clinical Trials
52,630 Total Patients Enrolled
3 Trials studying Sepsis
9,201 Patients Enrolled for Sepsis
St. Louis Children's HospitalOTHER
29 Previous Clinical Trials
41,046 Total Patients Enrolled
1 Trials studying Sepsis
8,800 Patients Enrolled for Sepsis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- N/AI am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: PICU Clinicians and Sepsis stakeholders
- Group 2: PICU Patients with suspected sepsis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study open to new participants?
"As per clinicaltrials.gov, recruitment for this medical trial is no longer taking place; the initial post was published on August 1st 2023 and the most recent update were released on July 27th of that same year. However, there are still 249 other trials actively seeking participants."
Answered by AI
Are there any healthcare facilities in North America conducting this trial?
"This trial is being offered at 4 separate medical sites, including the Johns Hopkins Children's Center in Baltimore, St. Louis Children's Hospital in Saint Louis, and Children's Hospital of Philadelphia in Philadelphia; there are additionally four other potential locations for enrolment."
Answered by AI
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