Zavicefta (ceftazidime–avibactam) | Spørsmål og svar - FAQs

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Frequently asked questions (FAQs)

Effective treatments for cIAI, cUTI, HAP/VAP and bacteraemia associated with cIAI, cUTI and HAP/VAP are already available — is there really a need for a new antibiotic combination?
Can clinical experience with ceftazidime be applied when using ZAVICEFTA
Is ZAVICEFTA an effective alternative to carbapenems?
There is time pressure when selecting the right antimicrobial for critically ill patients. Why should ZAVICEFTA be considered as an early treatment option in adult patients?
Why should ZAVICEFTA be used as a treatment for suspected Gram-negative infections?
I would like to know more about my country’s epidemiology and carbapenem resistance. Does Pfizer have any website offering such information?

1. Effective treatments for cIAI, cUTI, HAP/VAP and bacteraemia associated with cIAI, cUTI and HAP/VAP are already available — is there really a need for a new antibiotic combination?

In the field of antibiotics, all effective new treatment options are a welcome addition to the clinical armamentarium
For most patients with cIAI, cUTI, HAP/VAP and bacteraemia associated with cIAI, cUTI and HAP/VAP, the causative bacteria are generally susceptible to the commonly used antibiotics, which is why people believe that the treatments are effective. There are, however, some infections caused by bacteria that are resistant to commonly used agents, which will mean that drugs with a broader spectrum of activity will need to be used^1‒3
Antibiotic resistance is a growing global problem, and cUTI, cIAI, HAP/VAP and bacteraemia associated with cIAI, cUTI and HAP/VAP are associated with increased healthcare costs due to initial empirical treatment failure.^4‒8 To treat patients effectively and minimise the risk of antibiotic resistance, new drugs need to be introduced⁹
The increasing prevalence of MDR organisms and, in particular, the spread of carbapenem resistance among Gram-negative pathogens, is a significant concern, requiring new antimicrobial treatments, such as ZAVICEFTA, which was developed as an alternative treatment for serious infections caused by Gram-negative pathogens¹⁰

Abbreviation:

cIAI, complicated intra-abdominal infections; cUTI, complicated urinary tract infections; HAP, hospital-acquired pneumonia; MDR, multidrug-resistant; VAP, ventilator-associated pneumonia.

References:

Carlet J, et al. Antimicrob Resist Infect Control 2012;1:25.

Gupta N, et al. Clin Infect Dis 2011;53:60–7.

Doi Y, et al. Semin Respir Crit Care Med 2015;36:74–84.

Bassetti M, et al. Curr Opin Crit Care 2018;24:385–93.

Kongnakorn T, et al. Int J Antimicrob Agents 2019;54:633–41.

Lau WK, et al. Antimicrob Agents Chemother 2006;50:3556–61.

Zilberberg MD, et al. BMC Infect Dis 2017;17:279.

Stewart A, et al. Antimicrob Agents Chemother 2018;62:e01195-18.

Carlet J, et al. Antimicrob Resist Infect Control 2012;1:11.

Shirley M. Drugs 2018;78:675–92.

2. Can clinical experience with ceftazidime be applied when using ZAVICEFTA?

The addition of avibactam to ceftazidime restores activity of ceftazidime against β-lactam‑resistant Gram-negative pathogens
To date, published PK data have shown that no additional considerations need to be taken when dosing ZAVICEFTA compared with ceftazidime alone
The safety and tolerability profile of ZAVICEFTA is also similar to that of ceftazidime alone

Reference:

Zhanel GG, et al. Drugs 2013;73:159–77.

3. Is ZAVICEFTA an effective alternative to carbapenems?

The effectiveness of antibiotics to treat Gram-negative pathogens has been compromised by the presence of ESBLs as well as AmpC and KPC β-lactamases¹
ZAVICEFTA is as effective as a carbapenem, with the benefit of in vitro activity against carbapenem-resistant Gram-negative pathogens, including KPC- and OXA-48‑producing strains^2–7
ZAVICEFTA has been shown to be as effective as carbapenem therapy in both cIAI (when used in combination with metronidazole) and cUTI (including pyelonephritis). If a Gram-positive infection is suspected, additional coverage will be required^2–4
ZAVICEFTA also offers an alternative to carbapenems in patients with HAP/VAP caused by Gram-negative pathogens, particularly in the setting of proven or suspected bacterial resistance⁵
Because ZAVICEFTA also covers CRE, it may serve more appropriately as an alternative to carbapenems for severe and invasive infections with ESBLs or AmpC-producing Enterobacterales¹

References:

Corcione S, et al. Curr Opin Infect Dis 2019;32:663–73.

Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.

Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.

Wagenlehner FM, et al. Clin Infect Dis 2016;63:754−62.

Torres A, et al. Open Forum Infect Dis 2019;6:ofz149.

Mazuski JE, et al. Surg Infect (Larchmt) 2017;18:1–76.

ZAVICEFTA SPC

Abbreviations:

AmpC, ampicillin class C; cIAI, complicated intraabdominal infections; cUTI, complicated urinary tract infections; CRE, carbapenem-resistant Enterobacterales; ESBL, extended-spectrum β-lactamase; HAP, hospital-acquired pneumonia; KPC, Klebsiella pneumoniae carbapenemase; OXA, oxacillinase; VAP, ventilator-associated pneumonia.

4. There is time pressure when selecting the right antimicrobial for critically ill patients. Why should ZAVICEFTA be considered as an early treatment option in adult patients?

Early adequate antibiotic therapy is crucial for patients with serious Gram-negative infections¹
Failure to treat early and appropriately leads to worse outcomes in patients with serious Gram-negative infections–60% increase in length of stay, 50% increase in duration of antibiotic therapy, 30% decrease in likelihood of being discharged home and 20% increase in risk of in-hospital mortality or discharge to a hospice¹
Early identification of patients at risk for MDR Gram-negative infections is vital for appropriate selection of adequate, early antimicrobial therapy to reduce the risk of fatal outcomes.^1–3 A variety of risk factors are associated with MDR Gram-negative infections. These include:^2‒5
- Fragility risk factors: patients with >3 comorbidities, immunosuppression, neutropoenia, recent surgery (within 1 month) and age >60 years
- Probability of resistance: recent carbapenem and/or fluoroquinolone (within 3 months), two recent hospital admissions (within 12 months), risk of CRE colonisation (e.g. hospital outbreak in ICU or travel to high endemic areas), comorbidities suggesting high consumption of antibiotics (e.g. chronic obstructive pulmonary disease, cystic fibrosis, diabetes), temporary devices and permanent intrusive devices (e.g. catheters, ventilators)
- Severity risk factors: bloodstream infection, severe sepsis/septic shock, HAP/VAP, no improvement in 24 to 48 hours
ZAVICEFTA is a treatment option for patients at high risk for MDR Gram-negative infections with suspected or documented CRE (KPC, OXA-48), P. aeruginosa or ESBL- and AmpC-producing pathogens^6–9
ZAVICEFTA is as effective as a carbapenem, with the benefit of in vitro activity against carbapenem-resistant Gram-negative pathogens, including KPC- and OXA-48‑producing strains^6,10,11–15
ZAVICEFTA has a safety and tolerability profile consistent with both cephalosporins and carbapenems^12–15

Abbreviation:

AmpC, ampicillin class C; CRE, carbapenem-resistant Enterobacterales; ESBL, extended-spectrum β-lactamase; HAP, hospital-acquired pneumonia; ICU, intensive care unit; KPC, Klebsiella pneumoniae carbapenemase; MDR, multidrug-resistant; OXA, oxacillinase; VAP, ventilator-associated pneumonia.

References:

Bonine NG, et al. Am J Med Sci 2019;357:102–10.

Bassetti M, et al. Curr Opin Crit Care 2018;24:385–95.

De Waele JJ, et al. Intensive Care Med 2018;44:189–96.

Miller B, et al. Antimicrob Agents Chemother 2016;44:134–7.

Albur M, et al. Ann Clin Microbiol Antimicrob 2016;15:23.

ZAVICEFTA SPC

Bassetti M, et al. Curr Opin Infect Dis 2018;31:177–86.

Lagacé-Wiens P, et al. Core Evid 2014;9:13–25.

Zhanel GG, et al. Drugs 2013;73:159–77.

Mazuski JE, et al. Surg Infect (Larchmt) 2017;18:1–76.

Pogue JM, et al. Clin Infect Dis 2019;68:519–24.

Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.

Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.

Torres A, et al. Lancet Infect Dis 2018;18:285–95.

Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62.

5. Why should ZAVICEFTA be used as a treatment for suspected Gram-negative infections?

Antibiotic resistance and MDR outbreaks are a growing global problem and contribute significantly to the negative clinical outcomes, higher rates of mortality, increased length of stay and increased costs due to initial empirical therapy failure^1,2:
- A 30-day mortality rate of 43.4 % has been associated with delayed appropriate antimicrobial therapy in patients with P. aeruginosa infections³
- In Greece, a 28-day mortality rate of 40% has been reported in patients with carbapenemase-producing K. pneumoniae strain infections⁴
- According to the INCREMENT study, a 30-day mortality rate of 33.7% has been reported in patients with infections caused by ESBL-producing K. pneumoniae and a rate of 17.4% for infections caused by ESBL-producing E. coli across 12 countries⁵
- In Spain, a 30-day mortality rate of 50% has been seen in patients with infections caused by OXA-48–producing Enterobacterales⁶
- In Greece, an overall mortality rate of 54.2% has been seen in patients with infections caused by KPC-producing K. pneumoniae⁷
ZAVICEFTA is used for the treatment of patients at high risk of MDR Gram-negative infections with suspected or documented P. aeruginosa, CRE (KPC, OXA-48), ESBL- and AmpC-producing pathogens^8–11
ZAVICEFTA is as effective as a carbapenem, with the benefit of in vitro activity against carbapenem-resistant Gram-negative pathogens, including KPC- and OXA-48–producing strains,^8,10–15
ZAVICEFTA has a safety and tolerability profile consistent with both cephalosporins and carbapenems^13–16

Abbreviation:

AmpC, ampicillin class C; CRE, carbapenem-resistant Enterobacterales; ESBL, extended-spectrum β-lactamase; KPC, Klebsiella pneumoniae carbapenemase; MDR, multidrug-resistant; OXA, oxacillinase.

References:

Zilberberg MD, et al. BMC Infect Dis 2017;17:279.

Bonomo RA, et al. Clin Infect Dis 2018;66:1290–7.

Kang C, et al. Clin Infect Dis 2003;37:745–51.

Daikos GL, et al. Antimicrob Agents Chemother 2014;58:2322–8.

Scheuerman O, et al. Infect Control Hosp Epidemiol 2018;39:660–7.

Navarro-San Francisco C, et al. Clin Microbiol Infect 2013;19:72–9.

Zarkotou O, et al. J Clin Microbiol 2010;48:2271–4.

ZAVICEFTA SPC

Bassetti M, et al. Curr Opin Infect Dis 2018;31:177–86.

Lagacé-Wiens P, et al. Core Evid 2014;9:13–25.

Zhanel GG, et al. Drugs 2013;73:159–77.

Pogue JM, et al. Clin Infect Dis 2019;68:519–24.

Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.

Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.

Torres A, et al. Lancet Infect Dis 2018;18:285–95

Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62.

6. I would like to know more about my country’s epidemiology and carbapenem resistance. Does Pfizer have any website offering such information?

ATLAS, a hub for Pfizer anti-infectives, is a comprehensive resource that is continuously developing
ATLAS includes a fully searchable database built initially with antibacterial surveillance data from the TEST (Tigecycline Evaluation Surveillance Trial) surveillance programme, followed by data from the AWARE (Assessing Worldwide Antimicrobial Resistance Evaluation) and INFORM (International Network for Optimal Resistance Monitoring) programmes
ATLAS now also encompasses data from the SENTRY antifungal surveillance programme
Using a selection of analysis methods, the user is able to process the data from a single surveillance programme or a combination of surveillance programmes and produce reports in tabular and graphical formats, as well as highly visual geographical heatmap displays of antibacterial or antifungal resistance over time
The ATLAS database is regularly updated (every 6–8 months), and other resources will be added
You can register at https://atlas-surveillance.com/#/login

Abbreviation:

ATLAS, Antimicrobial Testing Leadership and Surveillance, AWARE, Assessing Worldwide Antimicrobial Resistance Evaluation; INFORM, International Network for Optimal Resistance Monitoring; TEST, Tigecycline Evaluation Surveillance Trial

Reference:

Antimicrobial Testing Leadership and Surveillance. https://atlas-surveillance.com/#/login. Accessed May 2023.

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