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

Phase 3

Completed

• Conditions: Uncomplicated Urinary Tract Infections
• Interventions: Drug: Sulopenem-Etzadroxil/Probenecid; Drug: Ciprofloxacin

• Registration Number: NCT03354598
• Lead Sponsor: Iterum Therapeutics, International Limited

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-25
• Study First Posted: 2017-11-28
• Study Start: 2018-08-01
• Status Verified: 2019-12
• Primary Completion: 2020-01-16
• Study Completion: 2020-01-20
• Results First Submitted: 2020-11-20
• Results First Submitted QC: 2020-11-20
• Results First Posted: 2020-12-17
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1671

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sulopenem-etzadroxil/probenecid	Sulopenem-Etzadroxil/Probenecid	Sulopenem-etzadroxil/probenecid 500 mg PO twice daily for 5 days
Ciprofloxacin	Ciprofloxacin	Ciprofloxacin 250 mg PO administered twice daily for 3 days

Primary Outcome Measures

Name	Time	Method
Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success	Day 12 +/- 1 day	Overall Success is Clinical Success (resolution of uUTI symptoms present at study entry and no new uUTI symptoms) AND Microbiologic success (eradication of the baseline pathogen)
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success	Day 12+/-1 day	Overall Success: Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)

Secondary Outcome Measures

Name	Time	Method
Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success	Day 12+/-1 day	Microbiologic success is defined as eradication of the baseline pathogen (\<1000 Colony Forming Units (CFU)/mL) at the Test of Cure visit

Trial Locations

Locations (1)

Medical Facility; 🇺🇸 South Jordan, Utah, United States