N/A N=743 Randomized Single-blind Diagnostic

Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

Bacteremia · Fungemia · Bloodstream Infection

Bottom Line

View on ClinicalTrials.gov: NCT01898208 ↗

Enrolled (actual)

743

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Duration of Antimicrobial Therapy (Hours) — 44; 42; 42; 8.2 hours — p=0.92

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FilmArray testing (Device); Antimicrobial Stewardship (Behavioral); Bacterial culture (Other); Susceptibility testing (Other)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Mayo Clinic
Primary completion: Aug 2014

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

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)?

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

View full record on ClinicalTrials.gov →

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.