A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections
Condition: Complicated Urinary Tract Infections or Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Intervention: Doripenem; Doripenem placebo; Cefepime; Cefepime placebo; Amoxicillin/clavulanate potassium
Intervention description: Type=once every 8 hours infused over 60 minutes, Unit=mg,Number=20mg/kg up to 500mg/dose, Form=solution for infusion,Route=intravenous use. At least 3 days of iv doripenem administered every 8 hours immediately after each iv infusion of cefepime placebo for up to 14 days; Form=solution for infusion, Route=intravenous use, administered once every 8 hours infused over 60 minutes immediately following each iv infusion of cefepime for up to 14 days; Type=once every 8 hours, Unit=mg, Number=50 mg/kg up to 2g/dose, Form=solution for infusion, Route=intravenous use. At least 3 days of iv cefepime administered every 8 hours infused over 30 minutes immediately before each iv infusion of doripenem placebo for up to 14 days; Form=solution for infusion, Route=intravenous use, administered once every 8 hours infused over 30 minutes immediately before each iv infusion of doripenem for up to 14 days; Form=suspension or tablets, Route=oral (by mouth), may be administered at the discretion of the investigator once every 12 hours for up to 14 days following IV therapy with doripenem or cefepime.
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Cefepime; Doripenem; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 3 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Antibiotic; Child, Hospitalized; Complicated Urinary Tract Infection; Pyelonephritis; Doripenem; Cefepime

Summary:

      The purpose of this study is to evaluate the safety and tolerability of doripenem compared to
      cefepime in children hospitalized with complicated urinary tract infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are eligible for the study must have a current episode of cUTI or
             pyelonephritis

          -  Have evidence of pyuria that meets criteria specified in the study protocol

          -  Have a study-qualifying pretreatment "baseline" urine culture specimen obtained by an
             acceptable method within 48 hours before the start of the administration of the first
             dose of iv study drug from which a bacterial pathogen is isolated with a growth of >=
             100000 colony forming units (CFU)/mL

          -  Require hospitalization initially and 10 to 14 days of antibacterial therapy [of which
             at least 72 hours should be iv therapy] for the treatment of the presumed UTI

          -  Have a signed informed consent form completed by the patient's parent or legal
             representative (and a signed assent form obtained from patients who are capable of
             providing assent, typically, children 7 years of age or older)

        Exclusion Criteria:

          -  Have a history of hypersensitivity reactions to carbapenems, cephalosporins,
             penicillins, or other beta-lactam antibiotics

          -  concomitant infection including but not limited to suspected or confirmed meningitis
             or central nervous system infection requiring systemic antibiotic or antifungal
             therapy in addition to the iv study drug therapy at the time of randomization

          -  Receipt of any amount of systemic antibiotic within 96 hours before obtaining the
             study-qualifying pretreatment baseline urine or systemic antibiotic therapy for more
             than 24 hours after obtaining the study-qualifying pretreatment baseline urine
             specimen

          -  Have a diagnosis of intractable UTI/pyelonephritis infection anticipated to require
             more than 14 days of study drug therapy, a permanent indwelling bladder catheter or
             instrumentation including nephrostomy or current urinary catheter that will not be
             removed or anticipation of urinary catheter placement that will not be removed during
             the course of iv study drug therapy administration, complete and permanent obstruction
             of the urinary tract, confirmed fungal UTI, suspected or confirmed perinephric or
             intrarenal abscess, suspected or confirmed prostatitis, known ileal loops, or any of
             the following clinically significant laboratory abnormalities: absolute neutrophil
             count (ANC) <500 cells/µL, platelet count <40,000 cells/µL, serum alanine
             aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >5x the
             age-specific upper limit of normal (ULN), acute or chronic renal insufficiency with a
             baseline creatinine clearance <60 mL per minute or requires dialysis therapy for any
             reason

          -  Have a history of uncontrolled epilepsy defined as at least 1 seizure within the 6
             months before randomization