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Biomarker-Guided Antibiotic Strategy for Sepsis
N/A
Waitlist Available
Led By Ebbing Lautenbach, MD,MPH,MSCE
Research Sponsored by University of Pennsylvania
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 two years
Awards & highlights
Study Summary
This trial will test whether a biomarker-based algorithm can reduce unnecessary antibiotic use in different ICUs, and assess the costs of the intervention.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of antibiotic therapy started upon enrollment for presumed sepsis
Secondary outcome measures
Subject's Final Disposition
Other outcome measures
Clinical Cure
Length of stay
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Biomarker Algorithm InterventionExperimental Treatment1 Intervention
The Algorithm arm is equivalent to the intervention. Biomarker algorithm along with the patient's biomarker assay results will be given to clinical team to assist in deciding to continue antibiotics.
The intervention will consist of using the biomarker identified as useful in Phase I to compile an algorithm along containing the patient's biomarker assay results and providing this as additional information for a clinical team consider using to assist in deciding to continue antibiotics. Biomarker algorithms may be different for adult versus pediatric patients, and across different types of ICUs.
Group II: ObservationalActive Control1 Intervention
9 blood biomarkers (including C reactive protein and Procalcitonin) will be assessed across 3 days. Results will not be shared with the subject's medical team. At 3 days, the definitive diagnosis of infection will be determined using Center for Disease Control (CDC) criteria; this will serve as the gold standard for determining biomarker test characteristics. Additional data to collect: demographics, comorbidities, medication use (like antibiotics), lab cultures, x-rays, sepsis resolution, length of hospital stay, and ultimate outcome (i.e., discharge, death). Phase I will identify the biomarker(s) providing the greatest negative predictive value in identifying patients at very low likelihood bacterial infection.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,009 Previous Clinical Trials
42,894,508 Total Patients Enrolled
4 Trials studying Sepsis
102,560 Patients Enrolled for Sepsis
Ebbing Lautenbach, MD,MPH,MSCEPrincipal InvestigatorUniveristy of Pennsylvania
1 Previous Clinical Trials
585 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Biomarker Algorithm Intervention
- Group 2: Observational
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.
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