Pharmacokinetics and Safety of Single Intravenous Doses of Ceftolozane/Tazobactam in Children With Proven or Suspected Gram-Negative Infection

The Pediatric Infectious Disease Journal
John S BradleyElizabeth G Rhee

Abstract

Drug-resistant Gram-negative bacteria are a growing threat to children; thus new antibiotics are needed to treat infections caused by these pathogens. Ceftolozane/tazobactam is active against many Gram-negative pathogens and is approved for treatment of complicated intra-abdominal and urinary tract infections in adults, but has not been evaluated in children. This phase 1, noncomparative, open-label, multicenter study characterized the pharmacokinetics (by noncompartmental analysis), safety, and tolerability of single intravenous doses of ceftolozane/tazobactam in pediatric patients (birth [7 days postnatal] to < 18 years of age) with proven/suspected Gram-negative infection or receiving perioperative prophylaxis (clinicaltrials.gov NCT02266706). Patients were enrolled into 1 of 6 age groups to receive a single, age-based ceftolozane/tazobactam dose, with timed blood sample collection for determining plasma concentrations of ceftolozane and tazobactam. Safety and tolerability were also evaluated. Thirty-seven patients received study drug; 34 were included in the pharmacokinetic population. Ceftolozane and tazobactam pharmacokinetic parameters were generally comparable for patients 3 months to < 18 years of age. Patients from bi...Continue Reading

References

Oct 1, 1987·Clinical Pharmacokinetics·R de Groot, A L Smith
Oct 1, 1994·The Journal of Antimicrobial Chemotherapy·M KomuroJ Shimada
Oct 11, 2008·Pediatric Nephrology : Journal of the International Pediatric Nephrology Association·Malin M RhodinNick H G Holford
Jan 23, 2009·Journal of the American Society of Nephrology : JASN·George J SchwartzSusan L Furth
Feb 5, 2014·Antimicrobial Agents and Chemotherapy·Myra WooleyGurudatt Chandorkar
Jul 16, 2014·Pediatrics·Verica IvanovskaAukje K Mantel-Teeuwisse
Oct 1, 2014·Pediatric Research·Lawrence C Ku, P Brian Smith
Feb 12, 2015·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Joseph SolomkinChristian Eckmann
Aug 26, 2015·Drug Resistance Updates : Reviews and Commentaries in Antimicrobial and Anticancer Chemotherapy·Antonio OliverCarlos Juan
Oct 27, 2015·Pharmacotherapy·Keith S Kaye, Jason M Pogue
Dec 2, 2015·Journal of the Pediatric Infectious Diseases Society·Latania K LoganUNKNOWN CDC Epicenters Prevention Program
Apr 22, 2016·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·David van Duin, Robert A Bonomo
May 5, 2016·Pharmacological Research : the Official Journal of the Italian Pharmacological Society·Raffaele CoppiniKarel Allegaert
May 22, 2016·Infectious Disease Clinics of North America·Amos AdlerDror Marchaim
May 6, 2017·The Journal of Infectious Diseases·Helen W BoucherUNKNOWN Infectious Diseases Society of America

❮ Previous
Next ❯

Citations

Dec 7, 2018·Current Opinion in Pediatrics·James B WoodC Buddy Creech
Oct 10, 2019·Expert Opinion on Drug Metabolism & Toxicology·Manon TauzinRobert Cohen
Dec 18, 2019·Antimicrobial Agents and Chemotherapy·David Aguilera-AlonsoFernando Baquero-Artigao
Feb 8, 2020·The Pediatric Infectious Disease Journal·Leah MolloyJocelyn Y Ang
May 19, 2020·Pediatric Pulmonology·Antonio C ArrietaMatthew L Rizk
Jul 15, 2020·Expert Review of Anti-infective Therapy·Ignacio Martin-LoechesAlejandro Rodriguez
Dec 17, 2020·Antibiotics·Laura Butragueño-LaisecaMaría José Santiago
Nov 13, 2020·Clinical Microbiology Reviews·Dafna YahavLeonard Leibovici

❮ Previous
Next ❯

Related Concepts

Related Feeds

Antifungals (ASM)

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.

Antifungals

An antifungal, also known as an antimycotic medication, is a pharmaceutical fungicide or fungistatic used to treat and prevent mycosis such as athlete's foot, ringworm, candidiasis, cryptococcal meningitis, and others. Discover the latest research on antifungals here.