Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014)
Condition: Urinary Tract Infection (UTI); Complicated Urinary Tract Infection; Pyelonephritis; Uncomplicated Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Intervention: MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)
Intervention description: MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion
Intervention MeSH terms: Tazobactam; Ceftolozane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, multi-site, non-randomized, open-label study evaluating the safety and
      efficacy of MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) for the treatment of
      complicated urinary tract infection (cUTI) including pyelonephritis (uncomplicated or
      complicated pyelonephritis and complicated lower urinary tract infection) in Japanese
      participants. Efficacy will be primarily assessed by microbiological response defined as
      eradication of the baseline pathogen or pathogens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese males or females who need hospitalization

          -  Clinical signs and/or symptoms of urinary tract infection (UTI) at screening visit,
             either one of the following:

               -  Pyelonephritis (uncomplicated or complicated)

               -  Complicated lower UTI (cUTI)

          -  Has a pretreatment baseline urine culture specimen obtained within 24 hours of start
             of study drug

          -  Requires IV antibacterial therapy for the treatment of the presumed UTI

          -  Female participants of child bearing potential must not be pregnant (negative human
             chorionic gonadotropin test) or breastfeeding and must agree to use adequate
             contraception for the duration of the study and up to 35 days after the last dose of
             study drug

          -  Male participants must agree to use adequate contraception for the duration of the
             study and up to 75 days after the last dose of study drug

        Exclusion Criteria:

          -  Has a history of recent or recurrent Gram-positive organism UTI suggesting
             colonization, or participant with UTI that shows or suspects the presence of a
             Gram-positive organism only

          -  Has a history of any moderate or severe hypersensitivity or allergic reaction to any
             Beta-lactam antibacterial including cephalosporins, carbapenems and penicillins, or
             tazobactam

          -  Has a concomitant infection at the time of randomization, which requires non-study
             systemic antibacterial therapy in addition to study drug with the exception of an
             antibacterial with Gram-positive activity only (vancomycin, linezolid, daptomycin and
             teicoplanin)

          -  Is receiving probenecid

          -  Is currently receiving bladder infusions with topical urinary antiseptics or
             antibacterial agents

          -  Has received any amount of potentially therapeutic antibacterial therapy after
             collection of the pretreatment baseline urine culture and before administration of the
             first dose of study drug.

          -  Has received any dose of a potentially therapeutic antibacterial agent for the
             treatment of the current UTI within 48 hours before the pretreatment baseline urine is
             obtained

          -  Intractable urinary infection at baseline that would require more than 7 days of study
             drug

          -  Has complete, permanent obstruction of the urinary tract.

          -  Has confirmed fungal urinary tract infection at time of randomization (with ≥ 10^3
             fungal colony forming units /mL)

          -  Has permanent indwelling bladder catheter or urinary stent including nephrostomy

          -  Has suspected or confirmed perinephric or intrarenal abscess

          -  Has suspected or confirmed prostatitis, urethritis, or epididymitis

          -  Has ileal loop or known vesico-ureteral reflux

          -  Severe impairment of renal function including an estimated CrCl < 30 mL/min,
             requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20
             mL/hr urine output over 24 hours)

          -  Has urinary catheter that is not scheduled to be removed before the end of therapy

          -  Has any rapidly progressing disease or immediately life-threatening illness including
             acute hepatic failure, respiratory failure, and septic shock

          -  Has an immunocompromising condition (i.e., AIDS, hematological malignancy, or bone
             marrow transplantation, or immunosuppressive therapy) or is receiving ≥ 40 mg of
             prednisone per day administered continuously for > 14 days prior to study start

          -  Has participated in any clinical study of an investigational product within 30 days
             prior to the first dose of study drug

          -  Has previously participated in any study of ceftolozane or MK-7625A.