Table 3.
Randomized controlled trials evaluating clinical impact of rapid blood culture antimicrobial susceptibility testing methods.
| Study, year, location | Study design | Rapid (intervention) method | SOC (control) method | Rapid test performance | Outcomes of rapid test compared with standard methods | Rapid testing paired with antimicrobial stewardship | Comment |
|---|---|---|---|---|---|---|---|
| Doern, 1994, USA (74) | Single-center prospective 2-arm RCT (N = 573) | Baxter MicroScan WalkAway-96 reported same day | Baxter MicroScan WalkAway-96 reported following day | Time to AST result 16 h faster than SOC | Decreased mortality, ancillary tests, cost Change in antibiotic therapy was 15 h faster in rapid AST arm No difference in LOS |
No | Randomization scheme based on first letter of patient last name |
| Beuving, 2015, Netherlands (75) | Single-center prospective 2-arm RCT (N = 250) | Growth in presence of antibiotics assessed by 16S rRNA PCR | BD Phoenix | 94% agreement with SOC AST Time to AST result 15 h faster than SOC |
Decreased TOT No differences in mortality, LOS |
No | Rapid AST was not implemented optimally and results were not used by clinicians Underpowered to detect differences in clinical outcomes |
| Banerjee, 2015, USA (20) | Single-center, prospective 3-arm RCT (N = 617) | BioFire BCID and BCID plus stewardship | MALD-TOF, agar dilution | 97% agreement for on-panel organisms 19% of isolated organisms not on rapid test panel Time to AST result 49 h faster than SOC |
Decreased TOT Faster time to escalation and de-escalation, less treatment of contaminants, less broad-spectrum antibiotic treatment No differences in mortality, LOS, adverse events, cost |
Yes Audit and feedback by ID pharmacist or physician 24/7 in one intervention arm; treatment guidance comments included in microbiology result report for both intervention arms |
More impact among Gram-positive than Gram-negative infections Population had low resistance rates Underpowered to detect differences in clinical outcomes |
| Kim, 2020, Korea (76) | Single-center, prospective 2-arm RCT of patients with hematologic malignancies (N = 89) | QMAC-dRAST (QuantaMatrix, Inc.) | MALDI-TOF, MicroScan, VITEK 2 | Agreement with SOC not reported. Time to AST result 35 h faster than SOC |
Decreased TOT Less broad-spectrum antibiotic use No differences in mortality, Clostridium difficile, multidrug-resistant infections |
Yes ID team reviewed all patients |
Excluded patients in both arms with off-panel organisms |
| Banerjee, 2020, USA (19) | Multi-center prospective 2-arm RCT of patients with Gram-negative bacteremia (N = 448) | Accelerate Pheno System | MALDI-TOF, broth microdilution or agar dilution | Time to AST 36 h faster than SOC | Decreased TOT No differences in mortality, LOS, adverse events, cost |
Yes Audit and feedback by ID pharmacist or physician Mon–Friday during the day |
Greater impact for more resistant isolates Population had low resistance rates Underpowered to detect differences in clinical outcomes |
PCR, polymerase chain reaction; SOC, standard of care; MALDI-TOF, matrix-assisted laser desorption–ionization time of flight; TOT, time to optimal therapy; LOS, length of stay; AST, antibiotic susceptibility testing; ID, infectious diseases; BCID, Blood Culture Identification.