What side effects are associated with this type of intervention?

The most common treatments for sepsis include antibiotics such as vancomycin, beta-lactams, and aminoglycosides. Vancomycin can cause nephrotoxicity and ototoxicity, while beta-lactams may lead to allergic reactions and gastrointestinal disturbances. Aminoglycosides are also associated with nephrotoxicity and ototoxicity. Supportive treatments like tight glucose control can result in hypoglycemia, and low-tidal-volume ventilation strategies may cause ventilator-associated lung injury. These side effects highlight the importance of careful monitoring and individualized treatment plans.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of sepsis, including broad-spectrum agents like vancomycin, which is often used in severe cases involving gram-positive bacteria. Other approved antibiotics include beta-lactams, aminoglycosides, and fluoroquinolones, which target a range of bacterial pathogens. The Multifaceted Stewardship Intervention trial aims to optimize the use of these antibiotics through clinical guidelines, feedback, and education to reduce unnecessary vancomycin use, thereby minimizing resistance and improving patient outcomes. Additionally, supportive therapies such as vasopressors (e.g., norepinephrine) and fluid resuscitation are critical components of sepsis management.

What other types of research exist?

Promising novel alternatives to multifaceted stewardship interventions for sepsis patients include: 1) CRP-guided antibiotic duration to potentially reduce treatment length without compromising outcomes, 2) early transition from parenteral to oral antibiotics in uncomplicated cases, and 3) enhanced source control measures, such as timely catheter removal and abscess drainage. These strategies focus on optimizing antibiotic use and improving infection management.

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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

Summary

This trial aims to reduce the overuse of the antibiotic vancomycin in children's intensive care units by creating guidelines, educating doctors, and monitoring their usage. This approach targets both patients and clinicians to prevent kidney damage caused by unnecessary antibiotic use. Vancomycin has been frequently overused, leading to different methods aimed at reducing its inappropriate use and preventing resistance.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in vancomycin use

Secondary study objectives

30-day PICU readmission

30-day hospital readmission

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

+6 more

Other study objectives

Acceptability of intervention

Adoption of intervention

Appropriateness of intervention

+1 more

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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatments for sepsis include antibiotics, fluid resuscitation, and vasopressors. Antibiotics work by targeting and eliminating the underlying bacterial infection, which is crucial for controlling the source of sepsis. Fluid resuscitation helps to restore blood volume and improve circulation, counteracting the hypotension and shock associated with sepsis. Vasopressors are used to constrict blood vessels and increase blood pressure, ensuring vital organs receive adequate blood flow. The Multifaceted Stewardship Intervention focuses on optimizing antibiotic use through clinical guidelines, feedback, and education, which is essential to prevent antibiotic resistance and ensure effective treatment for sepsis patients.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

721 Previous Clinical Trials

8,551,827 Total Patients Enrolled

5 Trials studying Sepsis

9,268 Patients Enrolled for Sepsis

Children's Healthcare of AtlantaOTHER

167 Previous Clinical Trials

53,863 Total Patients Enrolled

3 Trials studying Sepsis

9,201 Patients Enrolled for Sepsis

St. Louis Children's HospitalOTHER

29 Previous Clinical Trials

35,322 Total Patients Enrolled

1 Trials studying Sepsis

8,800 Patients Enrolled for Sepsis

Media Library

PICU Clinicians and Sepsis stakeholders Clinical Trial Eligibility Overview. Trial Name: NCT05975671 — N/A

Sepsis Research Study Groups: PICU Clinicians and Sepsis stakeholders, PICU Patients with suspected sepsis

Sepsis Clinical Trial 2023: PICU Clinicians and Sepsis stakeholders Highlights & Side Effects. Trial Name: NCT05975671 — N/A

PICU Clinicians and Sepsis stakeholders 2023 Treatment Timeline for Medical Study. Trial Name: NCT05975671 — N/A

~22826 spots leftby Aug 2025

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