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Clinical Therapeutics

Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients

John S. Bradley, Jon Armstrong, Antonio Arrieta, Raafat Bishai, Shampa Das, Shirley Delair, Timi Edeki, William C. Holmes, Jianguo Li, Kathryn S. Moffett, Deepa Mukundan, Norma Perez, José R. Romero, David Speicher, Janice E. Sullivan, Diansong Zhou
John S. Bradley
aUniversity of California, San Diego, California, USA
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Jon Armstrong
bAstraZeneca, Macclesfield, United Kingdom
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Antonio Arrieta
cChildren's Hospital of Orange County, Orange, California, USA
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Raafat Bishai
dAstraZeneca, Gaithersburg, Maryland, USA
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Shampa Das
bAstraZeneca, Macclesfield, United Kingdom
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Shirley Delair
eChildren's Hospital & Medical Center, Omaha, Nebraska, USA
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Timi Edeki
fAstraZeneca, Wilmington, Delaware, USA
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William C. Holmes
dAstraZeneca, Gaithersburg, Maryland, USA
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Jianguo Li
gAstraZeneca, Waltham, Massachusetts, USA
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Kathryn S. Moffett
hWest Virginia University, Morgantown, West Virginia, USA
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Deepa Mukundan
iUniversity of Toledo, Toledo, Ohio, USA
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Norma Perez
jUniversity of Texas Health Science Center, Houston, Texas, USA
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José R. Romero
kUniversity of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Arkansas, USA
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David Speicher
lUniversity Hospitals Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA
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Janice E. Sullivan
mUniversity of Louisville and Kosair Children's Hospital, Louisville, Kentucky, USA
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Diansong Zhou
gAstraZeneca, Waltham, Massachusetts, USA
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DOI: 10.1128/AAC.00862-16
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ABSTRACT

This study aimed to investigate the pharmacokinetics (PK), safety, and tolerability of a single dose of ceftazidime-avibactam in pediatric patients. A phase I, multicenter, open-label PK study was conducted in pediatric patients hospitalized with an infection and receiving systemic antibiotic therapy. Patients were enrolled into four age cohorts (cohort 1, ≥12 to <18 years; cohort 2, ≥6 to <12 years; cohort 3, ≥2 to <6 years; cohort 4, ≥3 months to <2 years). Patients received a single 2-h intravenous infusion of ceftazidime-avibactam (cohort 1, 2,000 to 500 mg; cohort 2, 2,000 to 500 mg [≥40 kg] or 50 to 12.5 mg/kg [<40 kg]; cohorts 3 and 4, 50 to 12.5 mg/kg). Blood samples were collected to describe individual PK characteristics for ceftazidime and avibactam. Population PK modeling was used to describe characteristics of ceftazidime and avibactam PK across all age groups. Safety and tolerability were assessed. Thirty-two patients received study drug. Mean plasma concentration-time curves, geometric mean maximum concentration (Cmax), and area under the concentration-time curve from time zero to infinity (AUC0–∞) were similar across all cohorts for both drugs. Six patients (18.8%) reported an adverse event, all mild or moderate in intensity. No deaths or serious adverse events occurred. The single-dose PK of ceftazidime and avibactam were comparable between each of the 4 age cohorts investigated and were broadly similar to those previously observed in adults. No new safety concerns were identified. (This study has been registered at ClinicalTrials.gov under registration no. NCT01893346.)

  • Copyright © 2016 Bradley et al.

This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.

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Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients
John S. Bradley, Jon Armstrong, Antonio Arrieta, Raafat Bishai, Shampa Das, Shirley Delair, Timi Edeki, William C. Holmes, Jianguo Li, Kathryn S. Moffett, Deepa Mukundan, Norma Perez, José R. Romero, David Speicher, Janice E. Sullivan, Diansong Zhou
Antimicrobial Agents and Chemotherapy Sep 2016, 60 (10) 6252-6259; DOI: 10.1128/AAC.00862-16

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Phase I Study Assessing the Pharmacokinetic Profile, Safety, and Tolerability of a Single Dose of Ceftazidime-Avibactam in Hospitalized Pediatric Patients
John S. Bradley, Jon Armstrong, Antonio Arrieta, Raafat Bishai, Shampa Das, Shirley Delair, Timi Edeki, William C. Holmes, Jianguo Li, Kathryn S. Moffett, Deepa Mukundan, Norma Perez, José R. Romero, David Speicher, Janice E. Sullivan, Diansong Zhou
Antimicrobial Agents and Chemotherapy Sep 2016, 60 (10) 6252-6259; DOI: 10.1128/AAC.00862-16
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