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A Randomized Controlled Trial of Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by P0253 Extended-Spectrum ß-lactamase-producing Escherichia coli Chitprasong Malaisri, MD,1 Arrug Wibulpolprasert, MD,2 Pitak Santanirand, PhD,3 Sasisopin Kiertiburanakul, MD, MHS1 1Department of Medicine, 2Department of Emergency Medicine, 3Department of Pathology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok 10400, Thailand [e-mail: [email protected]] • Inclusion criteria: 1) were over 18 years of age; (2) had a presumptive diagnosis of Table 2 Clinical outcomes of 26 patients Introduction acute pyelonephritis defined as pyuria (>10 leukocytes per high-power field in urine analysis) combined with one of all of the followings: fever (body temperature >38oC), Outcomes Sitafloxacin Ertapenem p-value • 80% UTIs are caused by E. coli urinary syndrome (dysuria, urgency, urinary frequency), flank pain or costovertebral (N=13) (N=13) • Increase infection of extended-spectrum ß- angle tenderness; (3) had positive urine culture for ESBL EC >105 colony forming units (CFU)/mL and; (4) voluntarily consented to be enrolled in the study. Clinical outcomes, n (%) lactamase-producing Escherichia coli (ESBL EC) • Carbapenems was initially given to all patients Cure at day 10 13/13 (100.0) 12/13 (92.3) 0.999 producing organisms in outpatient settings, especially • After day 3, patients were randomized to receive either Failure at day 10 0 (0.0) 0 (0.0) N/A related to UTIs oral sitafloxacin (100 mg twice daily) or IV ertapenem • Reduced the treatment options to a limited number • Course of treatment was completed within 10 days Recurrent at day 30 1 (7.7) 0 (0.0) 0.999 of antibiotics Bacteriological outcomes, n (%) • The efficacy of fluoroquinolones for the treatment of Results Eradication at day 10 10 (76.9) 9 (69.2) 0.999 ESBL-producing bacterial infection is still Table 1 Characteristics of 26 patients Persistence at day 10 2 (15.4) 0 (0.0) 0.480 controversial. Characteristics Sitafloxacin Ertapenem p-value • Aim: to compare the clinical and bacteriological (N=13) (N=13) • 22 (84.5%) strains were not susceptible to levoflxacin effectiveness of IV carbapenems followed by oral and ciprofloxacin, but only 2 strains were not 72.3 64.5 Median (IQR), years 0.663 sitafloxacin or IV ertapenem for the treatment of (51.9-76.4) (52.7-72.9) susceptible to sitafloxacin • Only 1 patient had diarrhea from sitafloxacin non-bacteremic acute pyelonephritis with ESBL EC Male gender, n (%) 5 (38.5) 5 (38.5) 0.999 Risk factors for antimicrobial resistant uropathogens, n (%) Conclusions Methods None 7 (53.9) 2 (15.4) 0.097 • Treatment of non-bacteremic acute pyelonephritis • A prospective randomized controlled trial of patients Antibiotic in the last 3 months 4 (30.8) 8 (61.5) 0.116 caused by ESBL EC with IV carbapenems followed by with a presumptive diagnosis of acute pyelonephritis Hospitalization in the last 3 2 (15.4) 6 (46.2) 0.089 caused by ESBL-producing pathogen months oral sitafloxacin is highly effective and well-tolerated • Both hospitalized and non-hospitalized patients were Bladder catheter 1 (7.7) 8 (61.5) 0.011* • Sitafloxacin may be an alternative choice for switching eligible Had underlying disease, n (%) 8 (61.5) 12 (92.3) 0.160 from IV to oral antibiotic therapy for ESBL EC infection .

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