A Prospective Randomized Study Comparing Ceftolozane/Tazobactam to Standard of Care in the Management of Neutropenia and Fever in Patients With Hematological Malignancies.
cancer patients
febrile neutropenia
fever
immunocompromised
leukemia
neutropenia
neutropenic fever
Journal
Open forum infectious diseases
ISSN: 2328-8957
Titre abrégé: Open Forum Infect Dis
Pays: United States
ID NLM: 101637045
Informations de publication
Date de publication:
Jun 2022
Jun 2022
Historique:
received:
10
11
2021
accepted:
10
02
2022
entrez:
6
6
2022
pubmed:
7
6
2022
medline:
7
6
2022
Statut:
epublish
Résumé
With increased use of antibiotics in high-risk patients, the investigation of new antibiotics to cover potentially resistant pathogens is warranted. In this prospective randomized trial, we compared ceftolozane/tazobactam (C/T), a new cephalosporin/β-lactamase inhibitor, to the standard of care (SOC) for the empiric treatment of neutropenia and fever in patients with hematological malignancies. We enrolled 100 patients to receive intravenous (IV) C/T or SOC antibiotics (cefepime, piperacillin/tazobactam, or meropenem) in combination with gram-positive antibacterial agents. We evaluated responses at the end of IV therapy (EOIV), test of cure (TOC; days 21-28), and late follow-up (LFU; days 35-42). We analyzed 47 C/T patients and 50 SOC patients. C/T patients had a higher rate of favorable clinical response at EOIV (87% vs 72%). A 1-sided noninferiority analysis indicated that C/T was at least not inferior to the SOC for favorable clinical response at EOIV ( The empiric use of C/T in high-risk patients with hematological malignancies and febrile neutropenia is safe and associated with better clinical outcomes than SOC antimicrobial agents. NCT03485950.
Sections du résumé
Background
UNASSIGNED
With increased use of antibiotics in high-risk patients, the investigation of new antibiotics to cover potentially resistant pathogens is warranted. In this prospective randomized trial, we compared ceftolozane/tazobactam (C/T), a new cephalosporin/β-lactamase inhibitor, to the standard of care (SOC) for the empiric treatment of neutropenia and fever in patients with hematological malignancies.
Methods
UNASSIGNED
We enrolled 100 patients to receive intravenous (IV) C/T or SOC antibiotics (cefepime, piperacillin/tazobactam, or meropenem) in combination with gram-positive antibacterial agents. We evaluated responses at the end of IV therapy (EOIV), test of cure (TOC; days 21-28), and late follow-up (LFU; days 35-42).
Results
UNASSIGNED
We analyzed 47 C/T patients and 50 SOC patients. C/T patients had a higher rate of favorable clinical response at EOIV (87% vs 72%). A 1-sided noninferiority analysis indicated that C/T was at least not inferior to the SOC for favorable clinical response at EOIV (
Conclusions
UNASSIGNED
The empiric use of C/T in high-risk patients with hematological malignancies and febrile neutropenia is safe and associated with better clinical outcomes than SOC antimicrobial agents.
Clinical Trials Registration
UNASSIGNED
NCT03485950.
Identifiants
pubmed: 35663286
doi: 10.1093/ofid/ofac079
pii: ofac079
pmc: PMC9154317
doi:
Banques de données
ClinicalTrials.gov
['NCT03485950']
Types de publication
Journal Article
Langues
eng
Pagination
ofac079Informations de copyright
© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
Références
Ann Hematol. 2008 Feb;87(2):139-45
pubmed: 17938926
Antimicrob Agents Chemother. 2013 Dec;57(12):6305-10
pubmed: 24100499
Antimicrob Agents Chemother. 2014 Sep;58(9):5350-7
pubmed: 24982069
Clin Infect Dis. 2020 Mar 3;70(6):1068-1074
pubmed: 31321410
J Infect. 2020 Dec;81(6):882-894
pubmed: 33186673
Infection. 2018 Jun;46(3):431-434
pubmed: 29460229
J Infect. 2014 Sep;69(3):266-77
pubmed: 24780763
Antimicrob Agents Chemother. 2013 Nov;57(11):5707-9
pubmed: 23939895
Mediterr J Hematol Infect Dis. 2019 Jan 01;12(1):e2020009
pubmed: 31934319
BMC Infect Dis. 2008 Jun 09;8:80
pubmed: 18541017
Antimicrob Agents Chemother. 2007 Oct;51(10):3510-5
pubmed: 17646415
Ann Hematol. 2012 May;91(5):767-774
pubmed: 22124621
Antimicrob Agents Chemother. 2019 Jan 29;63(2):
pubmed: 30530598
Lancet. 2015 May 16;385(9981):1949-56
pubmed: 25931244
Int J Antimicrob Agents. 2021 Jun;57(6):106335
pubmed: 33838223
Clin Infect Dis. 2011 Feb 15;52(4):e56-93
pubmed: 21258094
Int J Antimicrob Agents. 2015 Nov;46(5):502-10
pubmed: 26315199
Clin Infect Dis. 2015 May 15;60(10):1462-71
pubmed: 25670823
J Antimicrob Chemother. 2014 Oct;69(10):2713-22
pubmed: 24917579
Antimicrob Agents Chemother. 2005 Apr;49(4):1306-11
pubmed: 15793102
Antimicrob Agents Chemother. 2020 Mar 24;64(4):
pubmed: 32015035
Curr Opin Infect Dis. 2014 Apr;27(2):200-10
pubmed: 24573013
Virulence. 2016 Apr 2;7(3):280-97
pubmed: 27002635
Am J Health Syst Pharm. 2015 Dec 15;72(24):2135-46
pubmed: 26637512
Int J Antimicrob Agents. 2007 Nov;30 Suppl 1:S51-9
pubmed: 17689933
Clin Ther. 2015 Jul 1;37(7):1564-71
pubmed: 26088525
Eur J Clin Microbiol Infect Dis. 2013 Jul;32(7):841-50
pubmed: 23354675
Lancet Infect Dis. 2019 Dec;19(12):1299-1311
pubmed: 31563344
J Antimicrob Chemother. 2012 Jun;67(6):1311-20
pubmed: 22396430
J Clin Microbiol. 2014 Nov;52(11):4049-52
pubmed: 25143578