Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

Inclusion Criteria

• Adults ≥18 years of age with more than 24 hours of urinary symptoms attributable to a UTI
• Able to provide informed consent
• Clinically documented pyelonephritis or complicated urinary tract infection:
• Pyelonephritis with normal anatomy
• Complicated UTI as defined by one or more of the following factors:

i. The presence of an indwelling catheter ii. >100 mL of residual urine after voiding iii. Neurogenic bladder iv. Obstructive uropathy due to nephrolithiasis, tumor or fibrosis v. Azotemia due to intrinsic renal disease vi. Urinary retention in men possibly due to benign prostatic hypertrophy vii. Surgically modified or abnormal urinary tract anatomy

• At least two of the following signs or symptoms:
• Rigors, chills or fever/hypothermia
• Flank pain or pelvic pain
• Nausea or vomiting
• Dysuria, urinary frequency or urinary urgency
• Costovertebral angle tenderness on physical examination
• A mid-stream urine specimen with:
• a dipstick analysis positive for nitrite AND
• evidence of pyuria as defined by either: i. a dipstick analysis positive for leukocyte esterase AND/OR ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine AND/OR iii. White blood cell count ≥10 cells/high-powered field in urine sediment

Exclusion Criteria

• Receipt of effective antibacterial drug therapy for complicated urinary tract infection (cUTI) for a continuous duration of more than 24 hours during the previous 72 hours. Patients who have objective documentation of clinical progression of cUTI while on antibacterial drug therapy, or patients who received antibacterial drugs for surgical prophylaxis and then develop cUTI, may be appropriate for enrollment.
• Subjects with an organism isolated from the urine within the last year known to be resistant to ertapenem
• Severe structural or functional urinary tract abnormality responsible for an intractable infection which in the opinion of the investigator would require > 10 days of therapy or post-treatment prophylaxis (eg. patients with chronic vesiculo-ureteral reflux).
• Uncomplicated UTI
• Patients with paraplegia/quadriplegia
• Hypotension with systolic blood pressure 3 X Upper Limit of Normal
• Total bilirubin > 2 X Upper Limit of Normal
• Neutropenia (<1000 cells/mm3)
• Patients participating in any other clinical study that involved the administration of an investigational medication
• Patient immunocompromised
• Patients unlikely to comply with the protocol
• Patients considered unlikely to survive the 4-week study period or has a rapidly progressive or terminal illness