Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections

This is a phase I, open-label, single-dose study. The study aims to characterize the
pharmacokinetics of CAZ-AVI and assess its safety and tolerability following a single IV
dose given to hospitalized pediatric patients receiving systemic antibiotic therapy for
suspected or confirmed infection. This study will include 4 cohorts, each consisting of at
least 8 evaluable pediatric patients, aged ≥3 months to <18 years, who are hospitalized with
infections.

Inclusion Criteria:

1. Written informed consent will be obtained from parent(s) or other legally acceptable
representative(s), and informed assent from patient (if age appropriate) will be
obtained

2. Male or female children ages ≥3 months to <18 years.

3. Hospitalized, receiving systemic antibiotic therapy for the treatment of a suspected
or confirmed infection, and expected to require hospitalization until after the end
of treatment (EOT) evaluations are completed.

4. If female and has reached menarche, or has reached Tanner stage 3 breast development
(even if not having reached menarche), the patient is practicing appropriate birth
control or is sexually abstinent.

5. Likely to survive the current illness or hospitalization.

6. Sufficient intravascular access (peripheral or central) to receive study drug.

Exclusion Criteria:

1. History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin,
other β-lactam antibiotics.

2. If female, currently pregnant or breast feeding or has a positive serum β-human
chorionic gonadotropin (β-hCG) pregnancy test.

3. Receipt of a blood or blood component (e.g., red blood cells, fresh frozen plasma,
platelets) transfusion during the 24-hour period before enrolment.

4. BMI outside the range (below the 5th percentile or above the 85th percentile) for
height, age, and weight except for children <2 years of age.

5. Babies born prior to 37 weeks gestation (cohort 4 only).