A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI

Inclusion Criteria

• •Participant must be from birth to \<18 years of age. Participants up to 2 months must have been born at term or preterm with a gestational age ≥32 weeks.
• •Written informed consent from parent(s) or other legally acceptable representative(s), and informed assent from participant (if age appropriate according to local regulations).
• •If female and has reached menarche, or has reached Tanner stage 3 development, (even if not having reached menarche) the participant is authorized to participate in this clinical study if the following criteria are met:
• •1. Participant has a negative urine and/or serum human chorionic gonadotropin test at screening visit. As serum tests may miss an early pregnancy, relevant menstrual history, and sexual history, including methods of contraception, should be considered
• •2. Participant agrees to avoid conception from the time of screening until 7 days after receipt of study intervention and agrees not to attempt pregnancy from the time of screening until 7 days after EOT with study intervention, and participant agrees to follow guidelines received regarding continuation of abstinence, initiation of abstinence or about allowed contraception, and
• •3. Participant reports sexual abstinence for the prior 3 months or reported the use of at least 1 of the acceptable methods of contraception, including an intrauterine device (with copper banded coil), levonorgestrel intrauterine system or regular medroxyprogesterone injections, or participant agrees to initiate sexual abstinence from the time of screening until 7 days after end of treatment (EOT) with study intervention.
• •Participant has a clinically suspected and/or bacteriologically documented complicated urinary tract infection (cUTI) or acute pyelonephritis judged by the investigator to require the participant to be hospitalized for treatment with intravenous (i.v.) therapy.
• •The causative pathogen is confirmed or suspected to be susceptible to cefepime-enmetazobactam.
• •Participant has pyuria, defined as dipstick analysis positive for leukocyte esterase OR:
• •1. If ≥1 year of age: White blood cell (WBC) count \>10 cells/µL in unspun urine or ≥10 cells/high power field in spun urine.
• •2. If \<1 year of age: WBC count \>5 cells/µL in unspun urine or ≥5 cells/high power field in spun urine.
• •Participant demonstrates clinical signs and/or symptoms of either acute pyelonephritis or cUTI at the Screening Visit, as defined by the following criteria:
• •a. For pyelonephritis, participants must have at least 2 of the following new or worsening signs and/or symptoms: i. If 0 to \<2 years of age:
• •* Fever (as defined by the investigator)
• •* Failure to thrive
• •* Recent weight loss
• •* Irritability
• •* Poor feeding
• •* Lack of normal level of activity
• •* Abdominal tenderness on physical examination
• •* Vomiting ii. If 2 to \<18 years of age:
• •* Fever (as defined by the investigator)
• •* Dysuria
• •* Urinary urgency
• •* Urinary frequency
• •* New-onset urinary incontinence
• •* Suprapubic pain, flank pain, or abdominal pain
• •* Suprapubic tenderness or CVA tenderness on physical examination
• •* Nausea or vomiting OR
• •b. For cUTI, participants must have at least 2 of the new or worsening signs and/or symptoms listed above AND must have at least 1 of the following complicating factors:
• •* Obstructive uropathy
• •* Congenital, functional, or anatomic abnormality of the urogenital tract
• •* Temporary indwelling urinary catheter
• •* Bladder instrumentation within \<24 hours
• •* Recurrent UTI (≥2 events within a 12-month period)
• •Have a baseline urine culture specimen obtained within 48 hrs prior to the first dose of the study intervention. (Participants may be enrolled in this study and start i.v. study intervention therapy before the Investigator knows the results of the baseline urine culture in the event the causative pathogen is suspected to be susceptible to cefepime-enmetazobactam).
• •Specimen is to be obtained by suprapubic aspiration, clean intermittent urethral catheterization, indwelling urethral catheter, or mid- stream clean catch.
• •Likely to survive the current illness or hospitalization.
• •Sufficient intravascular access (peripheral or central) to receive study intervention