N/A
N=500
Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia
Gram-negative Bacteremia
Bottom Line
View on ClinicalTrials.gov: NCT03218397 ↗Enrolled (actual)
500
Serious AEs
—
Results posted
Nov 2019
Primary outcome: Primary: Hours to First Antibiotic Modification — 24.7; 19.0 hours — p=0.013
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Accelerate PhenoTest™ BC Kit (Device); Standard Culture and AST (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hours to First Antibiotic Modification |
24.7; 19.0 | 0.013 sig |
| SECONDARY Subjects Who Experienced Mortality Within 30 Days of Randomization |
18; 25; 206; 197; 2; 0 | 0.265 |
| SECONDARY Length of Stay in the Hospital |
8.2; 9.8 | 0.093 |
| SECONDARY ICU Status Through 72 Hours Post-randomization |
33; 55; 34; 37; 159; 130 | 0.014 sig |
| SECONDARY Time to First Antibiotic Escalation |
52.7; 45.2 | 0.009 sig |
| SECONDARY Time to First Gram-negative Antibiotic Escalation |
53.9; 47.5 | 0.022 sig |
| SECONDARY Time to First Gram-positive Antibiotic Escalation |
70.5; 69.7 | 0.46 |
| SECONDARY Time to First Antibiotic De-escalation |
44.2; 39.6 | 0.074 |
| SECONDARY Time to First Gram-negative Antibiotic De-escalation |
55.8; 49.3 | 0.008 sig |
| SECONDARY Time to First Gram-positive Antibiotic De-escalation |
60.4; 62.2 | 0.37 |
| SECONDARY Number of Hospital-onset Clostridium Difficile Infections |
26.8; 27.5 | — |
| SECONDARY Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days. |
123.3; 105.5 | — |
Summary
RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):
1. Standard culture and antimicrobial susceptibility testing (AST); or
2. Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)
Eligibility Criteria
Inclusion Criteria
- Positive blood culture with Gram stain showing GNB identified during local laboratory business hours.
Exclusion Criteria
- Identification of GNB outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)
- Positive blood culture for GNB at the same institution within prior 7 days (if known at the time of randomization).
- Deceased at the time of randomization.
- GNB plus gram-positive organism, gram-negative cocci, and/or yeast detected on Gram stain
- Previous enrollment in this study
- No Minnesota research authorization (Rochester site only)
Data sourced from ClinicalTrials.gov (NCT03218397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.