MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)
Condition: Complicated Urinary Tract Infection; Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Intervention: Ceftolozane/Tazobactam; Meropenem
Intervention description: 12 to <18 years of age: Ceftolozane 1 g/dose; Tazobactam 0.5 g/dose via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days. <12 years of age: Ceftolozane 20 mg/kg with Tazobactam 10 mg/kg (not to exceed Ceftolozane 1 g and Tazobactam 0.5 g) via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days.; Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days.
Intervention MeSH terms: Meropenem; Tazobactam; Ceftolozane; Ceftolozane, tazobactam drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 134.0
Sex: All
Minimum age: 7 Days
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam)
      compared with that of meropenem in pediatric participants with cUTI, including
      pyelonephritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a legally acceptable representative who provides documented informed consent /
             assent for the trial.

          -  Ages from birth (defined as >32 weeks gestational age and ≥7 days postnatal) to <18
             years of age.

          -  Requires IV antibacterial therapy for the treatment of cUTI.

          -  Have a pretreatment baseline urine culture specimen obtained within 48 hours before
             the start of administration of the first dose of study treatment and preferably prior
             to administration of any potentially therapeutic antibiotics.

          -  Has pyuria.

          -  Has clinical signs and/or symptoms of cUTI at the Screening Visit.

          -  Is not of reproductive potential; but if of reproductive potential agrees to avoid
             becoming pregnant or impregnating a partner during screening, while receiving study
             treatment and for at least 30 days after the last dose of study treatment.

          -  Female of reproductive potential is not pregnant, and not planning to become pregnant
             within 30 days of the last day of treatment administration; and is nonlactating.

        Exclusion Criteria:

          -  Is currently participating in or has participated in an interventional clinical trial
             with an investigational compound or device within 30 days prior to the first dose of
             study treatment in this current trial.

          -  Has previously participated in any trial of ceftolozane or ceftolozane/tazobactam or
             has enrolled previously in the current trial and been discontinued.

          -  Has a history of any moderate or severe hypersensitivity (e.g.anaphylaxis), allergic
             reaction, or other contraindication to any of the following: β-lactam antibiotics
             (e.g, penicillins, cephalosporins, and carbapenems), β-lactamase inhibitors (e.g.
             tazobactam, sulbactam, clavulanic acid, avibactam), or metronidazole.

          -  Has a history of a cUTI within the past 1 year prior to randomization known to be
             caused by a pathogen resistant to either IV study treatment.

          -  Has a concomitant infection at the time of randomization that requires nonstudy
             systemic antibacterial therapy in addition to IV study treatment or oral step -down
             therapy.

          -  Has received potentially therapeutic antibacterial therapy for a duration more than 24
             hours during the 48 hours preceding the first dose of study treatment.

          -  Has any of the following: a) intractable UTI or pyelonephritis infection at baseline
             that the Investigator anticipates would require more than 14 days of study treatment;
             b) confirmed fungal urinary tract infection at time of randomization; c) permanent
             indwelling bladder catheter or instrumentation including nephrostomy; d) current
             urinary catheter that is not scheduled to be removed before the end of all study
             treatment; e) complete, permanent obstruction of the urinary tract; f) suspected or
             confirmed perinephric or intrarenal abscess; g) documented ileal loop reflux; h)
             suspected or confirmed prostatitis, urethritis, or epididymitis; i) trauma to
             pelvis/urinary tract.

          -  Has moderate or severe impairment of renal function.

          -  Has a seizure disorder or is anticipated to be treated with divalproex sodium or
             valproic acid during the course of study treatment.

          -  Is receiving, or is expected to receive, any prohibited medications.

          -  Has any rapidly progressing disease or immediately life-threatening illness, including
             acute hepatic failure, respiratory failure, or septic shock.

          -  Has an immunocompromising condition.

          -  Has a history of malignancy ≤5 years prior to signing informed consent.

          -  Is planning to receive suppressive/prophylactic antibiotics with gram-negative
             activity after completion of study treatment.