Kun for helsepersonell

Søk

Menu

Close

Logg innLogg ut
LegemiddelTerapiområdeUtforsk merUtforsk merMateriellVideo/podkastNyhetsbrevKontakt oss

Menu

Close

Om ZaviceftaVirkningsmekanismePatogen dekningTidlig hensiktsmessig behandlingIDSA anbefalingØkonomiske holdepunkterSpørsmål og svar om ZAVICEFTAPasientprofilerHAP/VAP pasientcUTI pasientcIAI pasientPediatriske pasienterSpørsmål og svar - FAQsEffekt Real-world evidenceEffektdataSpørsmål og svar om effektSikkerhetSikkerhet hos voksneSikkerhet hos barn/ungdomSpørsmål og svar om sikkerhetDoseringDosering hos voksneDosering hos barn/ungdomSpørsmål og svar om dosering
Robust real-world evidence supports the use of ZAVICEFTA (ceftazidime–avibactam) when treatment options are limited* as shown in 44 studies with 
4971 patients1–44

CRE

Pseudomonas

ESBL

Limited treatment options

Bacteraemia

Treatment with ZAVICEFTA suggested a trend towards lower all-cause 30-day mortality compared with colistin36*

Scroll left to view table
  • ZAVICEFTA was associated with a trend of improved clinical outcomes, decreased all-cause hospital mortality and improved benefit–risk outcomes, compared with colistin for the treatment of CRE infections36‡

ZAVICEFTA demonstrated promising clinical results for severe infections caused by OXA-48-producing Enterobacterales for which treatment options are limited38*

Scroll left to view table
  • The majority of patients (81%) received ZAVICEFTA as monotherapy38
  • All-cause mortality was 14% at 14 days and 22% at 30 days38§
Listen to Professor Jonathan Edgeworth

Consultant Microbiologist from Guy’s and St. Thomas’ NHS Trust talks about the benefit of new antibiotics to treat CRE. He also presents his experience using ZAVICEFTA in a patient in intensive care with MDR Klebsiella.

In the largest real-world study with specific data on patients treated with ZAVICEFTA for P. aeruginosa infections, the composite clinical failure** and development of resistance was similar between the CRE and P. aeruginosa cohorts:4,49*

Scroll left to view table
  • Development of resistance to ZAVICEFTA was not detected in the patients evaluated with follow-up cultures4
  • 8.4% of patients experienced a potential drug-related AE

In a real-world retrospective multicentre study†† of patients who received ≥72 h of ZAVICEFTA for Gram-negative bacteria other than CRE, the clinical cure‡‡ rate was high across different causative agents:6*

Scroll left to view table
  • The only factor related to clinical failure was receipt of continuous renal replacement therapy at infection onset6
  • Development of resistance to ZAVICEFTA was not detected in the patients evaluated with follow-up cultures6
  • No treatment-related AEs were observed6

Treatment with ZAVICEFTA suggested a trend towards lower 30-day mortality compared with other treatment41*

Scroll left to view table
  • The overall 30-day mortality rate was 34.1%41
  • The highest rate (36.5%) was among patients with bacteraemic KPC-Kp infections; the lowest (16.7%) was observed in those with urinary tract infections41¶¶

Treatment with ZAVICEFTA suggested a trend towards lower all-cause 30-day mortality compared with colistin36*

Scroll left to view table

Treatment with ZAVICEFTA suggested a trend towards lower all-cause 30-day mortality compared with colistin36*

  • ZAVICEFTA was associated with a trend of improved clinical outcomes, decreased all-cause hospital mortality and improved benefit–risk outcomes, compared with colistin for the treatment of CRE infections36‡
ZAVICEFTA demonstrated promising clinical results for severe infections caused by OXA-48-producing Enterobacterales for which treatment options are limited38*
Scroll left to view table

Treatment with ZAVICEFTA suggested a trend towards lower all-cause 30-day mortality compared with colistin36*

  • The majority of patients (81%) received ZAVICEFTA as monotherapy38
  • All-cause mortality was 14% at 14 days and 22% at 30 days38§
ZAVICEFTA demonstrated promising clinical results for carbapenem-resistant Enterobacterales or P. aeruginosa for which treatment options are limited39*
Scroll left to view table

Treatment with ZAVICEFTA suggested a trend towards lower all-cause 30-day mortality compared with colistin36*

  • In this real-world retrospective case series, where the majority of patients (n=23) had life-threatening infections, 73.7% of patients experienced a trend towards clinical and/or microbiological cure at the end of treatment39***
Footnotes:*Limitations of real-world data analyses: the results from non-randomised, real-world data analyses are limited by potential selection bias and unknown confounding factors. Such studies contain additional clinical outcomes of ZAVICEFTA (ceftazidime–avibactam) in combination with other antimicrobials. Pfizer has data on combination therapy of ZAVICEFTA along with metronidazole, aminoglycosides, vancomycin and linezolid based only on Phase III trials and in vitro studies. Beyond this, Pfizer has no data to recommend combination therapy.
IPTW-adjusted estimates; adjustment for confounding by indication was performed using IPTW.36
In a real-world, prospective, observational study in 18 US hospitals from 2011 to 2016 in 137 patients with documented CRE infections (bloodstream [46%], respiratory tract [22%] and urinary tract [14%] infections).36
§In a single-centre study in a Spanish hospital of a large cohort of patients with carbapenem-resistant infections caused by OXA-48-producing Enterobacterales who were treated with ZAVICEFTA as salvage therapy (N=57). Patients treated with ZAVICEFTA (for ≥48 hours) for any OXA-48-producing carbapenem-resistant Enterobacterales infection between 1 April 2016 and 31 December 2017. The most frequent source of infection was intraabdominal (28%), followed by HAP/VAP (26%) and urinary source (25%); bacteraemia was confirmed in 46% of patients.38
A multicentre, retrospective, observational cohort study conducted at six geographically diverse academic medical centres in the United States between 2015 and 2019. Inclusion criteria were as follows: (1) age ≥18 years and (2) receipt of ≥72 hours of ZAVICEFTA. For each patient, only the initial ZAVICEFTA treatment course during the study period was included.4
**The primary outcome was clinical failure defined as a composite of 30-day all-cause mortality, 30-day microbiological failure, and/or failure to resolve or improve signs or symptoms of infection on ZAVICEFTA.4
††This is a multicentre, retrospective case series of adult patients who received ZAVICEFTA for ≥72 h for documented infections caused by MDR Gram-negative bacteria other than CRE in 13 hospitals located in 9 Italian regions. The study was conducted from 1 July 2017 to 31 July 2019.6
‡‡Clinical cure was characterised as patients having complete resolution of clinical signs and symptoms related to the infection and/or infection cleared with no positive cultures reported at the end of ZAVICEFTA therapy.6
§§A matched cohort of patients whose bactaeremic KPC-Kp infections had been managed in the participating centres receiving ≥72 hours of salvage therapy regimens that did not include ZAVICEFTA. Cohorts were matched for days before salvage therapy (± 1 day) and Pitt bacteraemia scores (± 1 point) at the start of salvage therapy.41
¶¶In a retrospective, multicentre study in 17 Italian hospitals in patients with documented KPC-Kp infections (N=138). Patients treated for KPC-Kp infections between 1 April 2016 and 31 December 2017; 75% were bacteraemic and 25% were non-bacteraemic infections involving (in order of decreasing frequency) the lower respiratory tract, intra-abdominal structures, the urinary tract or other sites.41
***In a case series of 38 patients with infections caused by carbapenem-resistant Enterobacterales or P. aeruginosa who were treated with ZAVICEFTA as salvage therapy. Patients were treated in Europe and Australia between 2013 and 2016; 36 were infected with carbapenem-resistant Enterobacterales and two with carbapenem-resistant P. aeruginosa. The most common infections were intra-abdominal (n=15) and HAP/VAP (n=7), and 26 patients had bacteraemia.39
Abbreviations:AE, adverse events; BJI, bone and joint infection; CPE, carbapenemase-producing Enterobacterales; CRE, carbapenem-resistant Enterobacterales; cSSTI, complicated skin and soft-tissue infection; ESBL, Extended Spectrum Beta-Lactamase; IPTW, inverse probability of treatment weighting; HAP, hospital-acquired pneumonia; Kp, Klebsiella pneumoniae; KPC, Klebsiella pneumoniae carbapenemase; MDR, multidrug resistance; OXA, oxacillinase; VAP, ventilator-associated pneumonia.Reference:Castón JJ, et al. J Antimicrob Chemother 2022;77:1452–60.Satlin MJ, et al. Clin Infect Dis 2022; doi: 10.1093/cid/ciac354.Atkin SD, et al. Infect Drug Resist 2018;11:1499–510.Jorgensen SCJ, et al. Open Forum Infect Dis 2019;6:ofz522.Corbella L, et al. Int J Antimicrob Agents 2022;59:106517.Vena A, et al. Antibiotics 2020;9:3390.Chen W, et al. Ann Transl Med 2020;8:39.Aitken SL, et al. Clin Infect Dis 2016;63:954–8.Shields RK, et al. Clin Infect Dis 2016;63:1615–8.Krapp F, et al. Int J Antimicrob Agents 2017;49:770–3.Santevecchi BA, et al. Int J Antimicrob Agents 2018;51:629–35.Shields RK, et al. Antimicrob Agents Chemother 2018;62:e02497-18.Algwizani A, et al. J Infect Public Health 2018;11:793–5.Rodríguez-Núñez O, et al. J Glob Antimicrob Resist 2018;15:136–9.Katchanov J, et al. PLoS One 2018;13:e0195757.Recio R, et al. Int J Antimicrob Agents 2018;52:172–9.De la Calle C, et al. Int J Antimicrob Agents 2019;53:520–4.Alraddadi BM, et al. BMC Infect Dis 2019;19:772.Spoletini G, et al. J Antimicrob Chemother 2019;74:1425–9.Iannaccone M, et al. J Chemother 2020;32:160–2.King M, et al. Antimicrob Agents Chemother 2017;61:e00449-17.Wang Q, et al. J Infect Public Health 2022;15:455–59.Bassetti M, et al. J Glob Antimicrob Resist 2019;17:109–11.Jorgensen SC, et al. Infect Dis Ther 2020;9:291–304.Ackley R, et al. Antimicrob Agents Chemother 2020;64:e02313-19.Zhang F, et al. Infect Drug Resist 2021;14:5165–74.Strich JR, et al. Clin Infect Dis 2021;72:611–21.Guimarães T, et al. Antimicrob Agents Chemother 2019;63:pii:e00528-19.Falcone M, et al. Crit Care 2020;24:29–41.Almangour TA, et al. Infect Drug Resist 2022;15:211–21.Balandín B, et al. Int J Antimicrob Agents 2022;59:106536.Chen J, et al. Infect Drug Resist 2022;15:655–67.Di Pietrantonio M, et al. Antibiotics (Basel) 2022;11:321.Gu J, et al. J Glob Antimicrob Resist 2021;26:20–5.Shi Y, et al. Infect Dis Ther 2021;10:2721–34.van Duin D, et al. Clin Infect Dis 2018;66:163–71.Castón JJ, et al. Int J Infect Dis 2017;59:118–23.Sousa A, et al. J Antimicrob Chemother 2018;73:3170–5.Temkin E, et al. Antimicrob Agents Chemother 2017;61:e01964-16.Shields K, et al. Antimicrob Agents Chemother 2017;61:e00883-17.Tumbarello M, et al. Clin Infect Dis 2019;68:355–64.Tumbarello M, et al. Clin Infect Dis 2021;73:1664–76.Tsolaki V, et al. Antimicrob Agents Chemother 2020;64:e02320-19.Rathish B, et al. Cureus 2021;13:e13081.Jabbour J-F, et al. Curr Opin Infect Dis 2020;33:146–54.Aguado JM, et al. Transplant Rev (Orlando) 2018;32:36–57.Soriano A, et al. Infect Dis Ther 2021;1–46.Mazuski JE, et al. Infect Dis Ther 2021;1–16.Daikos GL, et al. Antibiotics (Basel) 2021;10:1126.
Preparatomtale
PP-ZVA-NOR-0141 Mai 2023
Effekt

Pfizer AS, Org.nr 915 213 596

Postadresse: Postboks 3, 1324 Lysaker
Besøksadresse: Drammensveien 288, 0283 Oslo

Tlf.: +47 67 52 61 00


PP-BCP-NOR-0001 juni 2023

Copyright © 2023 Pfizer AS. Innholdet er rettighetsbeskyttet.

 




 

Du forlater nå PfizerPro.no
Nettstedet du kommer til er hverken eid eller kontrollert av Pfizer i Norge. Pfizer i Norge er ikke ansvarlig for innholdet på nettstedet du kommer til.
Kun for helsepersonell

Dette nettstedet er kun for helsepersonell.

Jeg bekrefter at jeg er helsepersonell som definert i legemiddelforskriften §13-1.

Ved å velge "nei" vil du komme til Pfizer.no som er åpen for allmenheten.

Ja Nei