Evaluate safety, tolerability, pharmacokinetics and efficacy of ceftazidime and avibactam compared with cefepime in children from 3 months to less than 18 years of age with complicated urinary tract infections (cUTIs)

What we are studying

The purpose of this research study is to compare the safety, tolerability, and effectiveness of CAZ AVI versus cefepime in persons between the ages of 3 months and 18 years of age with an infection in the urinary tract (called cUTI). This will be done by observing signs and symptoms of cUTI along with reviewing laboratory results.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • All Ages up to 17

Eligibility Criteria

  • Clinically suspected and/or bacteriologically documented cUTI or acute pyelonephritis judged by the Investigator to be serious and requires the patient to be hospitalised for treatment with IV therapy
  • Patient has pyuria
  • Patient has a positive urine culture.

What is involved

  • In patients will receive intravenous injection of CAZ-AVI or Intravenous injection of cefepime (required for at least 72 hours and no more than 14 days) After at least 72 hours (3 full days or 9 doses) of one of the above study therapies maybe switched to any one of the following oral treatments: o Oral ciprofloxacin o Oral cefixime o Oral amoxicillin + clavulanic acid o Oral sulfamethoxazole + trimethoprim o Or another therapy chosen based on the type of infection you have.
  • ECG will be performed 1st and 2nd day. Follow-up visits after end of IV therapy will occur 24
  • 48 hours
  • 8-15 days and 20-36 days.


Total $100.00

Contact Information

Study Coordinator
Nancy Lawlor

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.