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

Completed · Phase 3

Conditions studied: Complicated Urinary Tract Infections

In brief

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.

Key facts

Study ID

NCT03357614

Run by

Iterum Therapeutics, International Limited

People needed

1395

Starts

2018-09-18

Expected to finish

2019-12-14

Last updated by the study team

2020-12-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:

Where it is running

• Medical Facility — Bellflower, California, United States
• Medical Facility — Chula Vista, California, United States
• Medical Facility — La Mesa, California, United States
• Medical Facility — La Palma, California, United States
• Medical Facility — Torrance, California, United States
• Medical Facility — Miami Lakes, Florida, United States
• Medical Facility — Columbus, Georgia, United States
• Medical Facility — Idaho Falls, Idaho, United States
• Medical Facility — Boston, Massachusetts, United States
• Medical Facility — Royal Oak, Michigan, United States
• Medical Facility — Butte, Montana, United States
• Medical Facility — Columbus, Ohio, United States
• Medical Facility — Columbus, Ohio, United States
• Medical Facility — Dallas, Texas, United States
• Medical Facility — Houston, Texas, United States
• Medical Facility — Kohtla-Järve, Estonia
• Medical Facility — Tallinn, Estonia
• Medical Facility — Võru, Estonia
• Medical Facility — Tbilisi, Georgia
• Medical Facility — Tbilisi, Georgia
• Medical Facility — Tbilisi, Georgia
• Medical Facility — Baja, Hungary
• Medical Facility — Budapest, Hungary
• Medical Facility — Nagykanizsa, Hungary
• Medical Facility — Nyíregyháza, Hungary

Full record on ClinicalTrials.gov

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