PMID- 31910460
OWN - NLM
STAT- MEDLINE
DCOM- 20211210
LR  - 20211214
IS  - 1098-8785 (Electronic)
IS  - 0735-1631 (Linking)
VI  - 38
IP  - 8
DP  - 2021 Jul
TI  - Ceftolozane/Tazobactam in Neonates and Young Infants: The Challenges of 
      Collecting Pharmacokinetics and Safety Data in This Vulnerable Patient 
      Population.
PG  - 804-809
LID - 10.1055/s-0039-3402719 [doi]
AB  - OBJECTIVE: New treatments are needed for multidrug-resistant (MDR) gram-negative 
      infections in neonates. Ceftolozane/tazobactam is a beta-lactam/beta-lactamase 
      inhibitor combination that has broad-spectrum activity against most common 
      gram-negative bacteria, including MDR strains. We evaluated pharmacokinetics (PK) 
      and safety of ceftolozane/tazobactam in term and premature neonates and young 
      infants. STUDY DESIGN: This is a subgroup analysis of a phase 1, noncomparative, 
      open-label, multicenter study that characterized the PK, safety, and tolerability 
      of a single intravenous (IV) dose of ceftolozane/tazobactam in pediatric patients 
      with proven/suspected gram-negative infection or receiving perioperative 
      prophylaxis. RESULTS: Seven patients were enrolled in Group A (birth [7 days 
      postnatal] to < 3 months, > 32 weeks gestation) and six patients were enrolled in 
      Group B (birth [7 days postnatal] to < 3 months, </= 32 weeks gestation). PK 
      profiles in neonates and young infants were generally comparable to those of 
      older children receiving a single IV dose of ceftolozane/tazobactam. No serious 
      adverse events (AEs), treatment-related AEs, severe AEs, or clinically 
      significant laboratory abnormalities were reported. CONCLUSION: Among term and 
      premature neonates and young infants, PK was comparable to older children and 
      ceftolozane/tazobactam was generally well tolerated. An adaptable and flexible 
      study design is necessary for enrollment in neonatal PK trials.
CI  - Thieme. All rights reserved.
FAU - Ang, Jocelyn Y
AU  - Ang JY
AD  - Division of Infectious Diseases, Children's Hospital of Michigan, Detroit, 
      Michigan.
AD  - Department of Pediatrics, Wayne State University, Detroit, Michigan.
FAU - Arrieta, Antonio
AU  - Arrieta A
AD  - Division of Pediatric Infectious Disease, Children's Hospital of Orange County, 
      Orange, California.
FAU - Bradley, John S
AU  - Bradley JS
AD  - Division of Infectious Disease, Rady Children's Hospital, San Diego, California.
AD  - Department of Pediatrics, University of California San Diego School of Medicine, 
      La Jolla, California.
FAU - Zhang, Zufei
AU  - Zhang Z
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Yu, Brian
AU  - Yu B
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Rizk, Matthew L
AU  - Rizk ML
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Johnson, Matthew G
AU  - Johnson MG
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
FAU - Rhee, Elizabeth G
AU  - Rhee EG
AD  - Merck & Co., Inc., Kenilworth, New Jersey.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200107
PL  - United States
TA  - Am J Perinatol
JT  - American journal of perinatology
JID - 8405212
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Cephalosporins)
RN  - 0 (ceftolozane, tazobactam drug combination)
RN  - SE10G96M8W (Tazobactam)
SB  - IM
MH  - Anti-Bacterial Agents/adverse effects/*pharmacokinetics/therapeutic use
MH  - Antibiotic Prophylaxis
MH  - Cephalosporins/adverse effects/*pharmacokinetics/therapeutic use
MH  - Child
MH  - Clinical Trials as Topic/methods
MH  - Drug Resistance, Multiple, Bacterial
MH  - Female
MH  - Gram-Negative Bacterial Infections/*drug therapy/prevention & control
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Infant, Premature
MH  - Injections, Intravenous
MH  - Male
MH  - Preoperative Care
MH  - Tazobactam/adverse effects/*pharmacokinetics/therapeutic use
COIS- J.Y.A. has received institutional research funding and honoraria from Merck & 
      Co., Inc., Kenilworth, NJ. A.A. has received institutional research funding from 
      Merck & Co., Inc.. J.S.B. participated as an investigator in this trial, and his 
      employer received funding for institutional research and protocol design from 
      Merck & Co., Inc.. Z.Z., B.Y., M.L.R., M.G.J., and E.G.R. are employees of Merck 
      Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, and may 
      own stock and/or hold stock options in Merck & Co., Inc., Kenilworth, NJ.
EDAT- 2020/01/08 06:00
MHDA- 2021/12/15 06:00
CRDT- 2020/01/08 06:00
PHST- 2020/01/08 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2020/01/08 06:00 [entrez]
AID - 10.1055/s-0039-3402719 [doi]
PST - ppublish
SO  - Am J Perinatol. 2021 Jul;38(8):804-809. doi: 10.1055/s-0039-3402719. Epub 2020 
      Jan 7.