Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

• Status: Completed
• Trial end date: 2020-01-20
• Target enrollment: 0
• Participant gender: Female

Summary

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iterum Therapeutics, International Limited; Iterum Therapeutics, US Limited
• Treatments: Ciprofloxacin; Lactams; Probenecid

Criteria

Inclusion Criteria:

1. Female patients ≥18 years of age with 24-96 hours of urinary symptoms attributable to a urinary tract infection (UTI)

2. Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning micturition, suprapubic pain

3. A mid-stream urine specimen with:

1. a dipstick analysis positive for nitrite AND

2. evidence of pyuria as defined by either:

i. a dipstick analysis positive for leukocyte esterase ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine iii. White blood cell count ≥10 cells/high-powered field in the sediment of a spun urine

4. Has given written informed consent to participate in the study.

Exclusion Criteria:

1. Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature > 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting

2. Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days

3. Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI

4. Patients with ileal loops or urinary stoma

5. Patients with an indwelling urinary catheter in the previous 30 days

6. Patients with paraplegia

7. Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)

8. Any history of trauma to the pelvis or urinary tract

9. Patient's urine culture, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI

10. Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant

11. Known history of creatinine clearance <50 mL/min

12. Patients known to have liver disease

13. Patients who are pregnant, or females of child-bearing age unable to take adequate contraceptive precautions

14. Patients with uncontrolled diabetes mellitus

15. Patients with history of blood dyscrasias

16. Patients with history of uric acid kidney stones

17. Patients with acute gouty attack

18. Patients on chronic methotrexate therapy

19. Patient known to be immunocompromised

20. Patients with a known history of myasthenia gravis

21. Patients who require concomitant administration of tizanidine or valproic acid

22. Patients with a history of allergy or hypersensitivity to carbapenems, beta-lactams, quinolones or probenecid

23. Patient is considered unlikely to survive the 4-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality

24. History of seizures

25. Use of any other investigational drug in the 30 days prior to the study