Clinical trial NCT03354598: Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
Official title: A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uncomplicated Urinary Tract Infections
Lead sponsor: Iterum Therapeutics, International Limited
Sponsor class: INDUSTRY
First posted: 2017-11-28
Enrollment: 1671
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Participants With Overall Success
timeFrame: Day 12+/-1 day
measure: Percentage of Microbiologic Modified Intent to Treat Susceptible (Micro-MITTS) Participants With Overall Success
timeFrame: Day 12 +/- 1 day
Secondary outcomes:
measure: Percentage of Microbiologic Modified Intent to Treat Resistant (Micro-MITTR) Patients With Microbiologic Success
timeFrame: Day 12+/-1 day
Other outcomes:
measure: Percentage of Microbiologic Modified Intent to Treat (Micro-MITT) Participants With Overall Success
timeFrame: 12 +/- 1 day
Locations:
city: Birmingham
country: United States
facility: Medical Facility
state: Alabama
city: Phoenix
country: United States
facility: Medical Facility
state: Arizona
city: Tolleson
country: United States
facility: Medical Facility
state: Arizona
city: Cerritos
country: United States
facility: Medical Facility
state: California
city: Chula Vista
country: United States
facility: Medical Facility
state: California
city: Fullerton
country: United States
facility: Medical Facility
state: California
city: La Mesa
country: United States
facility: Medical Facility
state: California
city: Los Angeles
country: United States
facility: Medical Facility
state: California
city: San Diego
country: United States
facility: Medical Facility
state: California
city: Sylmar
country: United States
facility: Medical Facility
state: California
city: Washington
country: United States
facility: Medical Facility
state: District of Columbia
city: Bradenton
country: United States
facility: Medical Facility
state: Florida
city: Clearwater
country: United States
facility: Medical Facility
state: Florida
city: Doral
country: United States
facility: Medical Facility
state: Florida
city: Edgewater
country: United States
facility: Medical Facility
state: Florida
city: Hialeah
country: United States
facility: Medical Facility
state: Florida
city: Lauderdale Lakes
country: United States
facility: Medical Facility
state: Florida
city: Miami Springs
country: United States
facility: Medical Facility
state: Florida
city: Miami
country: United States
facility: Medical Facility
state: Florida
city: Miami
country: United States
facility: Medical Facility
state: Florida
city: Miami
country: United States
facility: Medical Facility
state: Florida
city: Miami
country: United States
facility: Medical Facility
state: Florida
city: Miami
country: United States
facility: Medical Facility
state: Florida
city: Miami
country: United States
facility: Medical Facility
state: Florida
city: Miami
country: United States
facility: Medical Facility
state: Florida
city: Miami
country: United States
facility: Medical Facility
state: Florida
city: New Port Richey
country: United States
facility: Medical Facility
state: Florida
city: Ormond Beach
country: United States
facility: Medical Facility
state: Florida
city: Palmetto Bay
country: United States
facility: Medical Facility
state: Florida
city: Saint Petersburg
country: United States
facility: Medical Facility
state: Florida
city: Winter Haven
country: United States
facility: Medical Facility
state: Florida
city: Atlanta
country: United States
facility: Medical Facility
state: Georgia
city: Norcross
country: United States
facility: Medical Facility
state: Georgia
city: Perry
country: United States
facility: Medical Facility
state: Georgia
city: Lake Charles
country: United States
facility: Medical Facility
state: Louisiana
city: Metairie
country: United States
facility: Medical Facility
state: Louisiana
city: New Orleans
country: United States
facility: Medical Facility
state: Louisiana
city: Las Vegas
country: United States
facility: Medical Facility
state: Nevada
city: Las Vegas
country: United States
facility: Medical Facility
state: Nevada
city: Brooklyn
country: United States
facility: Medical Facility
state: New York
city: Raleigh
country: United States
facility: Medical Facility
state: North Carolina
city: Hugo
country: United States
facility: Medical Facility
state: Oklahoma
city: Easley
country: United States
facility: Medical Facility
state: South Carolina
city: Lancaster
country: United States
facility: Medical Facility
state: South Carolina
city: Myrtle Beach
country: United States
facility: Medical Facility
state: South Carolina
city: Austin
country: United States
facility: Medical Facility
state: Texas
city: Austin
country: United States
facility: Medical Facility
state: Texas
city: Carrollton
country: United States
facility: Medical Facility
state: Texas
city: Corpus Christi
country: United States
facility: Medical Facility
state: Texas
city: Dallas
country: United States
facility: Medical Facility
state: Texas
city: Houston
country: United States
facility: Medical Facility
state: Texas
city: Houston
country: United States
facility: Medical Facility
state: Texas
city: Pearland
country: United States
facility: Medical Facility
state: Texas
city: Plano
country: United States
facility: Medical Facility
state: Texas
city: Sugar Land
country: United States
facility: Medical Facility
state: Texas
city: Bountiful
country: United States
facility: Medical Facility
state: Utah
city: Saint George
country: United States
facility: Medical Facility
state: Utah
city: Salt Lake City
country: United States
facility: Medical Facility
state: Utah
city: Salt Lake City
country: United States
facility: Medical Facility
state: Utah
city: South Jordan
country: United States
facility: Medical Facility
state: Utah
Study officials:
References: