Using Biomarkers to Optimize Antibiotic Strategies in Sepsis

NCT02207114 | Completed DMC

• 1 other identifier: 813623
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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 proposal will also assess the costs (or savings) of a biomarker-based intervention. Overall, the results of this work will be critical in informing future strategies to eliminate unnecessary antibiotic use and curb the continued rise in antimicrobial resistance.

Conditions

Sepsis

Keywords

Sepsis; Systemic Inflammatory Response Syndrome (SIRS); Antibiotic use; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Duration of antibiotic therapy started upon enrollment for presumed sepsis

  The primary outcome is the duration of antibiotic treatment after enrollment, expressed in days. This variable will focus specifically on the antibiotic agents given for the episode of presumed sepsis for which the patient was included in the study.

  Two years

Secondary Outcomes (1)

• Subject's Final Disposition

  Participants will be followed for the duration of hospital stay, an expected average of 6 days

Other Outcomes (2)

• Length of stay

  Participants will be followed for the duration of hospital stay, an expected average of 6 days

• Clinical Cure

  Participants will be followed for the duration of hospital stay, an expected average of 6 days

Study Arms (2)

Observational

NO 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.

Biomarker Algorithm Intervention

EXPERIMENTAL

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.

Other: Biomarker Algorithm Intervention

Interventions

Biomarker Algorithm Intervention OTHER

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.

Biomarker Algorithm Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania - Medical Intensive Care Unit

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sepsis; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Ebbing Lautenbach, MD,MPH,MSCE

  Univeristy of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: August 1, 2014
• Study Start: January 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)