Clinical Endpoints Achieved Across Mayo Clinic/UCLA, University of Iowa, and UAMS Studies
Sep 18, 2019
Accelerate Diagnostics, Inc. recently highlighted the release of positive results from three clinical studies on the Accelerate Pheno™ system that will be presented at IDWeek™ 2019.
“We are thrilled with the results of these clinical studies, which provide further evidence of the clinical value of Pheno,” commented Dr. Romney Humphries, Chief Scientific Officer of Accelerate Diagnostics. “These data, gathered across four diverse institutions and study designs, demonstrate that Pheno’s rapid ID and AST results lead to significant and potentially life-saving therapy optimization for patients with blood stream infections. These results represent a meaningful increase in the body of evidence that Pheno should be standard of care.”
The first of these studies is the ARLG-sponsored RAPIDS-GN clinical study conducted at Mayo Clinic and UCLA. The study successfully achieved its primary endpoint, demonstrating a statistically significant reduction in time to first antibiotic change for patients with Gram-negative blood stream infections. Specifically, the study showed a 6.3 hour decrease in time to first antibiotic adjustment and a 24.7 hour improvement in Gram-negative time to antibiotic adjustment, both of which represent statistically significant differences.
RAPIDS-GN is the first multi-center, randomized controlled trial to evaluate the impact of rapid ID and AST technology for the management of patients with blood stream infections. As expected, differences in secondary endpoints like mortality and length of stay did not achieve statistical significance. The study was not designed to include a sufficient number of patients to statistically evaluate these endpoints.
Randomized Clinical Trial Evaluating Clinical Impact of RAPid IDentification and Antimicrobial Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)
> RAPIDS-GN trial abstract on IDWeek.org
Two abstracts to be presented by the University of Iowa and University of Arkansas Medical System confirm and extend the findings of RAPIDS-GN. The University of Iowa showed antibiotic therapy was optimized within 15.3 hours for patients tested with Pheno. Among 277 interventions made based on Pheno results, 80% resulted in antibiotic change, and over one third were due to the patient not being covered for the causative organism identified.
Real-World Impact of Accelerate Pheno Implementation with Antimicrobial Stewardship Intervention
> UIHC abstract on IDWeek.org
Similarly, UAMS found a 1.1 day improvement in time to optimal therapy and confirmed prior findings that demonstrated between 0.5 and 2.4 days shorter length of stay for patients with bacteremia and tested by Pheno over historical cohorts (p<0.01).
Impact of Accelerate Pheno Rapid Blood Culture Detection System with Real Time Notification versus Standard Antibiotic Stewardship on Clinical Outcomes in Bacteremic Patients
> UAMS abstract on IDWeek.org
Additional data from these studies will be presented at the IDWeek™ conference in Washington, D.C. on October 3-5, 2019. The Company plans to provide further commentary at that time.
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