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About
This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.
Enrollment
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Volunteers
Inclusion and exclusion criteria
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:
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:
A mid-stream urine specimen with:
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 < 90 mm Hg
Complicated UTI associated with complete obstruction, emphysematous pyelonephritis, known or suspected renal or perinephric abscess or expected to require surgical intervention (not placement of catheters) to achieve cure
Patients with a known history of myasthenia gravis
Patients who require concomitant administration of tizanidine or valproic acid
Patients with a history of allergy to carbapenems or quinolones or amoxicillin-clavulanate or other beta-lactams, or hypersensitivity to probenecid
Renal transplantation
Patients requiring dialysis
Acute or chronic prostatitis
High risk for cUTI caused by Pseudomonas sp. (eg,. history of prior UTI due to Pseudomonas species, recent steroid use, others)
Chronic indwelling catheters or stents
Ileal loops or vesico-urethral reflux
Recent trauma to the pelvis or urinary tract within the prior 30 days
History of seizures
Patients with a history of blood dyscrasias
Patients with a history of uric acid kidney stones
Patients with acute gouty attack
Patients on chronic methotrexate therapy
Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy test result within 24 hours of study entry, are otherwise known to be pregnant, or are currently breastfeeding an infant.
Male subjects must agree to use of an effective barrier method of contraception during the study and for 14 days post treatment
Patients known to have a history of liver or kidney disease or neutropenia as defined by the following baseline laboratory criteria:
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
Primary purpose
Allocation
Interventional model
Masking
1,395 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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