Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
Condition: Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Intervention: Ceftazidime - Avibactam ( CAZ-AVI); Doripenem; Either switch to oral therapy: 500 mg of Ciprofloxacin (oral); or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
Intervention description: Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes; 500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes; Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement; Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
Intervention MeSH terms: Ciprofloxacin; Ceftazidime; Avibactam; Doripenem; Trimethoprim, Sulfamethoxazole Drug Combination; Trimethoprim; Sulfamethoxazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 598.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Ceftazidime, Avibactam, Doripenem, Ciprofloxacin, sulfamethoxazole/trimethoprim, Anti-Infective Agents, Complicated Urinary Tract Infection,Acute Pyelonephritis

Summary:

      The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to
      Doripenem for treating hospitalized patients with complicated urinary tract infections,
      including acute pyelonephritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 90 years of age inclusive

          -  Female patients can participate if they are surgically sterile or completed menopause
             or females capable of having children and agree not to attempt pregnancy while
             receiving IV study therapy and for a period of 7 days after

          -  Has pyuria with >/= 10 WBCs (white blood cell) and has a positive urine culture within
             48 hours of enrollment containing >/=10 to the fifth CFU (colony forming unit ) /ml of
             a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and
             doripenem)

          -  Demonstrates either acute pyelonephritis or complicated lower UTI without
             pyelonephritis.

        Exclusion Criteria:

          -  Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or
             doripenem

          -  Patient's urine culture at study entry isolates more than 2 microorganisms regardless
             of colony count or patient has a confirmed fungal UTI

          -  Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant

          -  Patient is immunocompromised

          -  Patient is considered unlikely to survive the 6- to 8-week study period or has a
             rapidly progressive or terminal illness including septic shock which is associated
             with a high risk of mortality