N/A
Completed N=743
Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures
Source: ClinicalTrials.gov NCT01898208 ↗Enrolled (actual)
743
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Duration of Antimicrobial Therapy (Hours) — 44; 42; 42; 8.2 hours — p=0.92
Summary
Would rapid identification of bacteria and rapid detection of methicillin-resistant S. aureus (MRSA) and vancomycin-resistant enterococci (VRE) (using an FDA-cleared assay) in positive blood culture bottles improve patient care at Mayo Clinic Rochester (or just lead to increased cost)?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Antimicrobial Therapy (Hours) |
44; 42; 42; 8.2; 0; 0 | 0.92 |
| SECONDARY Time From Positive Gram Stain to First Active Antibiotic |
11; 6; 4 | 0.55 |
| SECONDARY Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics |
34; 38; 21; 24; 6; 5 | <0.0001 sig |
| SECONDARY Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours |
75; 89; 92 | 0.015 sig |
| SECONDARY Time to Pathogen Identification |
22.3; 1.3; 1.3 | <0.0001 sig |
| SECONDARY Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment |
147; 131; 146 | 0.79 |
| SECONDARY Length of Entire Hospitalization (Days) |
8; 8; 8 | 0.60 |
| SECONDARY All-cause and Attributable Mortality |
22; 20; 18; 7; 7; 2 | 0.74 |
| SECONDARY Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events |
3; 3; 2 | 0.82 |
| SECONDARY Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment |
49.8; 49; 45.3 | — |
| SECONDARY Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject |
65,450; 66,887; 68,729; 5,377; 5,680; 5,743 | 0.7789 |
Eligibility Criteria
Inclusion criteria
- Positive blood culture during the study period.
- No positive blood cultures in prior 7 days
- Minnesota state research authorization provided
Exclusion criteria
- No Minnesota state research authorization
- Deceased or transitioned to comfort care within 24 hours of enrollment
- Positive blood culture in prior 7 days
- Previously enrolled in this study
- Negative Gram stain
Data sourced from ClinicalTrials.gov (NCT01898208). 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. Informational only — not medical advice.