Status:
COMPLETED
Using Biomarkers to Optimize Antibiotic Strategies in Sepsis
Lead Sponsor:
University of Pennsylvania
Conditions:
Sepsis
Eligibility:
All Genders
Phase:
NA
Brief Summary
The proposed work will provide critical insights into the potential impact of a biomarker-based algorithm on reducing unnecessary antibiotic use in different adult and pediatric/neonatal ICU's. This p...
Detailed Description
The goal of this project is reduce unnecessary use of antibiotics in the ICU. The purpose of Phase I of the study is to identify the biomarker, or combination of biomarkers, that provides optimal test...
Eligibility Criteria
Inclusion
- SIRS Criteria
- SIRS is considered to be present when patients have more than one of the following clinical findings:
- body temperature \>38°C or \<36°C
- heart rate \>90 min-1
- respiratory rate of \>20 min-1 or a Paco2 of \<32 mm Hg
- and a white blood cell count of \>12,000 cells µL-1 or \<4,000 µL-1
- new empiric antibiotic therapy is initiated, indicating the suspicion of infection. Accepted criteria for SIRS will be used for the Medical Intensive Care Unit and Surgical Intensive Care Unit populations, with appropriate age-specific vital signs definitions to help make the definitions relevant for the Pediatric Intensive Care Unit population.
Exclusion
- a code status of "do not resuscitate"
- absence of initiation or expansion of antibiotic therapy despite meeting criteria for sepsis
- presence of an immunocompromising condition.
- An immunocompromising condition will be defined as one of the following:
- human immunodeficiency virus (HIV) infection with a t-helper cell (CD4) count \<200 cell/mm3; 2) immunosuppressive therapy after organ transplantation
- neutropenia (\<500 neutrophils/mm3)
- active chemotherapy within the 3 months preceding eligibility or
- diagnosis of cystic fibrosis.
- These criteria all represent conditions in which antibiotic use is much less likely to be decreased regardless of the results of a biomarker and are consistent with exclusion criteria used in past studies of the impact of biomarkers.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT02207114
Start Date
January 1 2012
End Date
December 1 2023
Last Update
January 5 2024
Active Locations (1)
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1
Hospital of the University of Pennsylvania - Medical Intensive Care Unit
Philadelphia, Pennsylvania, United States, 19104