Clinical utility of PCR compared to conventional culture and sensitivity testing for the management of complicated urinary tract infections in adults: Part I. Assessment of clinical outcomes, investigator satisfaction scores, and turnaround times

Managing complicated urinary tract infections (cUTIs) poses significant challenges, often resulting in the overprescription of empiric antibiotics. This approach exposes patients to multiple antimicrobials and raises the risk of inadequate treatment efficacy. The purpose of this study is to assess and compare the clinical utility of molecular testing (PCR) versus conventional culture and sensitivity (C&S) in managing cUTI, to identify optimal management strategies for cUTI patients. 773 symptomatic adult patients with suspected cUTI diagnosis were randomized (1:1) into either the PCR-guided treatment group or the control group (C&S-guided) and followed up for 28 days. The primary outcome measure was the number (and percentage) of patients in each study arm with favorable clinical outcomes at the end of the study visit. Overall, 468 patients completed all study procedures, and of those, data from 362 patients were analyzed (193 PCR arm, 169 C&S arm) for this Part 1 of the primary study analysis. Treatments guided by PCR results provided significantly better clinical outcomes compared to treatments guided by conventional C&S results (88.08 % vs. 78.11, p = 0.011), with a significantly shorter mean turnaround time (49.68 h vs. 104.4 h, p < 0.001), and a significant higher investigator satisfaction total score (23.95 ± 1.96 vs. 20.64 ± 4.12, p < 0.001). This data demonstrated the clinical utility of PCR in improving therapeutic clinical outcomes and facilitating expedited, patient-specific management of cUTI for optimal patient care. Furthermore, this study showed a clear preference among investigators for PCR over C&S when making clinical decisions and managing patients with cUTI.