hospitalized pediatric patients receiving systemic antibiotic therapy for suspected or confirmed infection. MedDRA version: 14.1 Level: LLT Classification code 10021804 Term: Infection bacterial System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Fortum
Product Name: ceftazidime
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Ceftazidime Pentahydrate
CAS Number: 78439-06-2
Other descriptive name: CEFTAZIDIME PENTAHYD
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.) Male or female children ages =3 months to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.) History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other ß-lactam antibiotics 2.) If female, currently pregnant or breast feeding or has a positive serum ß 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Characterization of the pharmacokinetics of single-dose CAZ-AVI in a pediatric population;Secondary Objective: Assessment of the safety and tolerability of a single IV dose of CAZ-AVI given to hospitalized pediatric patients via Adverse Events, Vital Signs, Physical Examiniation, Laboratory Parameters and ECGs;Primary end point(s): The following PK parameters will be determined for ceftazidime and avibactam and will be listed and summarized: maximum plasma concentration (Cmax; µg/mL) following a single dose administration; time to Cmax (tmax; in hours) following a single-dose administration; area under the plasma concentration-time curve from zero to 8 hours after the end of infusion (AUC[0-8]), the time of the last quantifiable concentration (AUC[0-t]), extrapolated to infinity (AUC[0-8]); time of last quantifiable plasma concentration (tlast; in hours) taken directly from the individual concentration-time curve; terminal plasma half-life (t½; in hours) estimated as (ln2)/?z; systemic plasma clearance (CL; L/hour) estimated as dose divided by AUC(0-8); volume of distribution at the terminal phase (Vz; L) estimated by dividing the systemic clearance by ?z; volume of distribution at steady state (Vss, L) estimated by multiplying the mean residence time (MRT) by the CL; and terminal elimination phase rate constant (?z). ;Timepoint(s) of evaluation of this end point: Co-hort 1: Up to 22 hours post dose Co-hort 2: Up to 13 hours post dose Co-horts 3 and 4: Up to 6 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability will be assessed by Adverse Events reports and the results of vital sign measurements, physical examinations, clinical laboratory tests and ECGs. Tabulations and listings of data for vital signs, physical examinations, clinical laboratory tests, and ECGs will be presented.;Timepoint(s) of evaluation of this end point: From consent to 48 hours post dose | — |
Countries
United States
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed