The purpose of this research study is to determine if IV sulopenem followed by oral sulopenem-etzadroxil/probenecid is safe and at least as effective as standard treatment for urinary tract infections
Inclusion Criteria
- Clinically documented pyelonephritis or complicated urinary tract infection
- At least two of the following signs or symptoms:
- rigors, chills, or fever/hypothermia with temperature > 100.4°F or 38°C, or < 95°F or 35°C
- 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 machine-read dipstick positive for nitrite AND
- evidence of pyuria
Exclusion Criteria
- Receipt of effective antibacterial drug therapy for cUTI for a continuous duration of more than 24 hours in the 72 hours prior to randomization
- 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
Study Requirements
Approximately 1156 adults with cUTI will be randomized in a 1:1 fashion to receive either IV sulopenem 1000 mg once daily for at least 5 days (5 doses) followed by snlopenem-etzadroxil 500 mg co-administered with oral probenecid 500 mg twice daily to complete 7-10 total days of treatment or ertapenem IV 1000 mg once daily for at least 5 days (5 doses) followed by oral ciprofloxacin 500 mg or amoxicillin-clavulanate 875 mg twice daily to complete 7-10 total days of therapy. Duration of treatment may be extended up to a total duration of 14 days for patients with bacteremia at baseline. Total study participation will last approximately 28 days. At least 16 teaspoons (80 mL) to a maximum of30 teaspoons (150 mL) of blood will be collected over the entire study.
