Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
Condition: Complicated Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Intervention: CXA-101; Ceftazidime
Intervention description: intravenous; intravenous
Intervention MeSH terms: Ceftazidime; Ceftolozane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Complicated Urinary Tract Infection; Pyelonephritis; Antimicrobial; Cephalosporin; Intravenous

Summary:

      The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and
      comparator in complicated urinary tract infection
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females 18 to 90 years of age, inclusive.

          2. Pyuria (white blood cell [WBC] count > 10/µL in unspun urine or ≥ 10 per high power
             field in spun urine)

          3. Clinical signs and/or symptoms of cUTI, either of:

             a. Pyelonephritis, as indicated by both of the following: i. Fever (oral temperature ≥
             37.8°C); ii. Flank pain or costovertebral angle tenderness;

        OR

        b. Complicated lower UTI, as indicated by both of the following: i. At least one of the
        following new or worsening symptoms:

          -  Dysuria;

          -  Frequency;

          -  Suprapubic pain;

          -  Urgency

        ii. At least one of the following complicating factors:

          -  Male gender;

          -  Current bladder instrumentation or indwelling urinary catheter that is expected to be
             removed during the course of IV study drug administration;

          -  Obstructive uropathy that is expected to be medically or surgically treated during the
             course of IV study drug administration;

          -  Urogenital surgery within 7 days preceding administration of the first dose of study
             drug;

          -  Functional or anatomical abnormality of the urogenital tract including anatomic
             malformations or neurogenic bladder with voiding disturbance of at least 100 mL
             residual urine.

        Exclusion Criteria

          1. Documented history of any hypersensitivity or allergic reaction to any β-lactam
             antibacterial

          2. Concomitant infection requiring systemic antibacterial therapy in addition to IV study
             drug therapy at the time of randomization. Drugs with only gram-positive activity
             (e.g. vancomycin, linezolid) are allowed

          3. Complete, permanent obstruction of the urinary tract

          4. Confirmed (at time of randomization) fungal urinary tract infection (with ≥ 103 fungal
             CFU/mL)

          5. Suspected or confirmed perinephric or intrarenal abscess

          6. Suspected or confirmed prostatitis

          7. Known ileal loop or vesico-ureteral reflux

          8. Women who are pregnant or nursing