Ceftazidime/Avibactam Pfizer (ceftazidime and avibactam) is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options1*
*Only after consultation with a physician with appropriate experience in the management of infectious diseases.1cSSTI, complicated skin and soft-tissue infection; KPC, Klebsiella penumoniae carbapenemase; LTO, limited treatment options; MDR, multidrug-resistant; OXA, oxacillinase.References:1. Ceftazidime/Avibactam Pfizer [SmPC], Pfizer; 2. Tumbarello M, Viale P, Viscoli C, et al. Predictors of mortality in bloodstream infections caused by Klebsiella pneumoniae carbapenemase-producing K. pneumoniae: importance of combination therapy. Clin Infect Dis. 2012;55:943–950. 3. Caston JJ, Lacort-Peralta I, Martín-Dávila P, et al. Clinical efficacy of ceftazidime/avibactam versus other active agents for the treatment of bacteremia due to carbapenemase-producing Enterobacteriaceae in hematologic patients. Int J Infect Dis. 2017;59:118–123. 4. van Duin D, Lok JJ, Earley M, et al. Colistin Versus Ceftazidime-Avibactam in the Treatment of Infections Due to Carbapenem-Resistant Enterobacteriaceae. Clin Infect Dis. 2018;66:163–171. 5. . Sousa A, Pérez-Rodríguez MT, Soto A, et al. Effectiveness of ceftazidime/avibactam as salvage therapy for treatment of infections due to OXA-48 carbapenemase-producing Enterobacteriaceae. J Antimicrob Chemother. 2018;73:3170–3175. 6. Temkin E, Torre-Cisneros J, Beovic B, et al. Ceftazidime-Avibactam as Salvage Therapy for Infections Caused by Carbapenem-Resistant Organisms. Antimicrob Agents Chemother. 2017;61:e01964-16. 7. Shields RK, Nguyen MH, Chen L, et al. Ceftazidime-Avibactam Is Superior to Other Treatment Regimens against Carbapenem-Resistant Klebsiella pneumoniae Bacteremia. Antimicrob Agents Chemother. 2017;61:e00883-17. 8. Tumbarello M, Trecarichi EM, Corona A, et al. Efficacy of Ceftazidime-Avibactam Salvage Therapy in Patients With Infections Caused by Klebsiella pneumoniae Carbapenemase-producing K. pneumoniae. Clin Infect Dis. 2019;68:355-364.
Explore more Paediatric use Learn More LoadingRobust RWE supports the use of Ceftazidime/Avibactam Pfizer (ceftazidime and avibactam) when treatment options are limited as shown in more than 3493 patients1–30*The overall 30-day mortality rate was 34.1%. The highest rate (36.5%) was among patients with bacteraemic KPC-Kp infections; the lowest (16.7%) was observed in those with urinary tract infections7‡Ceftazidime/Avibactam Pfizer was associated with a trend of improved clinical outcomes, and a trend towards decreased all-cause hospital mortality and improved benefit-risk outcomes, for the treatment of CRE infections3ǁThe majority of patients (81%) received Ceftazidime/Avibactam Pfizer as monotherapy, all-cause mortality was 14% at 14 days and 22% at 30 days4¶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 treatment5#
*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. Pfizer has data on combination therapy of Ceftazidime/Avibactam Pfizer 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.
†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 Ceftazidime/Avibactam Pfizer. Cohorts were matched for days before salvage therapy (± 1 day) and Pitt bacteraemia scores (± 1 point) at the start of salvage therapy.7
‡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.7
§IPTW-adjusted estimates; adjustment for confounding by indication was performed using inverse probability of treatment weighting (IPTW).3
ǁIn 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).3
¶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 Ceftazidime/Avibactam Pfizer as salvage therapy (N=57). Patients treated with Ceftazidime/Avibactam Pfizer (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.4
#In a case series of 38 patients with infections caused by carbapenem-resistant Enterobacterales or P. aeruginosa who were treated with Ceftazidime/Avibactam Pfizer 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.5
CRE, carbapenem-resistant Enterobacterales; HAP, hospital-acquired pneumonia; KPC-Kp, Klebsiella penumoniae carbapenemase-producing Klebsiella penumoniae; IPTW, inverse probability of treatment weighting; LTO, limited treatment options; OXA, oxacillinase; RWE, real-world evidence; VAP, ventilator-acquired pneumonia.References:1. Aitken SL, Tarrand JJ, Deshpande LM, et al. High Rates of Nonsusceptibility to Ceftazidime-avibactam and Identification of New Delhi Metallo-β-lactamase Production in Enterobacteriaceae Bloodstream Infections at a Major Cancer Center. Clin Infect Dis 2016;63:954–958. 2. Caston JJ, Lacort-Peralta I, Martín-Dávila P, et al. Clinical efficacy of ceftazidime/avibactam versus other active agents for the treatment of bacteremia due to carbapenemase-producing Enterobacteriaceae in hematologic patients. Int J Infect Dis. 2017;59:118–123. 3. van Duin D, Lok JJ, Earley M, et al. Colistin Versus Ceftazidime-Avibactam in the Treatment of Infections Due to Carbapenem-Resistant Enterobacteriaceae. Clin Infect Dis. 2018;66:163–171. 4 Sousa A, Pérez-Rodríguez MT, Soto A, et al. Effectiveness of ceftazidime/avibactam as salvage therapy for treatment of infections due to OXA-48 carbapenemase-producing Enterobacteriaceae. J Antimicrob Chemother. 2018;73:3170–3175. 5. Temkin E, Torre-Cisneros J, Beovic B, et al. Ceftazidime-Avibactam as Salvage Therapy for Infections Caused by Carbapenem-Resistant Organisms. Antimicrob Agents Chemother. 2017;61:e01964-16. 6. Shields RK, Nguyen MH, Chen L, et al. Ceftazidime-Avibactam Is Superior to Other Treatment Regimens against Carbapenem-Resistant Klebsiella pneumoniae Bacteremia. Antimicrob Agents Chemother. 2017;61:e00883-17. 7. Tumbarello M, Trecarichi EM, Corona A, et al. Efficacy of Ceftazidime-Avibactam Salvage Therapy in Patients With Infections Caused by Klebsiella pneumoniae Carbapenemase-producing K. pneumoniae. Clin Infect Dis. 2019;68:355-364. 8. Shields RK, Potoski BA, Haidar G, et al. Clinical Outcomes, Drug Toxicity, and Emergence of Ceftazidime-Avibactam Resistance Among Patients Treated for Carbapenem-Resistant Enterobacteriaceae Infections. Clin Infect Dis 2016;63:1615–8; 9. Krapp F, Grant JL, Sutton SH, Ozer EA, Barr VO. Treating complicated carbapenem-resistant enterobacteriaceae infections with ceftazidime/avibactam: a retrospective study with molecular strain characterisation. Int J Antimicrob Agents. 2017;49:770–3; 10. Santevecchi BA, Smith TT, MacVane SH. Clinical experience with ceftazidime/avibactam for treatment of antibiotic-resistant organisms other than Klebsiella pneumoniae. Int J Antimicrob Agents 2018;51:629–35; 11. Shields RK, Nguyen MH, Chen L, Press EG, Kreiswirth BN, Clancy CJ. Pneumonia and Renal Replacement Therapy Are Risk Factors for Ceftazidime-Avibactam Treatment Failures and Resistance among Patients with Carbapenem-Resistant Enterobacteriaceae Infections. Antimicrob Agents Chemother 2018;62:e02497-17; 12. Algwizani A, Alzunitan M, Alharbi A, et al. Experience with ceftazidime-avibactam treatment in a tertiary care center in Saudi Arabia. J Infect Public Health. 2018;11:793–5. 13. Rodríguez-Núñez O, Ripa M, Morata L, et al. Evaluation of ceftazidime/avibactam for serious infections due to multidrug-resistant and extensively drug-resistant Pseudomonas aeruginosa. J Glob Antimicrob Resist. 2018;15:136–9; 14. De la Calle C, Rodríguez O, Morata L et al. Clinical characteristics and prognosis of infections caused by OXA-48 carbapenemase-producing Enterobacteriaceae in patients treated with ceftazidime-avibactam. Int J Antimicrob Agents. 2019;53:520–524; 15. Alraddadi BM, Saeedi M, Qutub M, Alshukairi A, Hassanien A, Wali G. Clinical characteristics and prognosis of infections caused by OXA-48 carbapenemase-producing Enterobacteriaceae in patients treated with ceftazidime-avibactam. BMC Infect Dis. 2019;19:772: 16. Katchanov J, Asar L, Klupp E, et al. Carbapenem-resistant Gram-negative pathogens in a German university medical center: Prevalence, clinical implications and the role of novel β-lactam/β-lactamase inhibitor combinations. PLoS One 2018;13:e0195757; 17. Recio R, Villa J, Viedma E, Orellana MA, Lora-Tamayo J, Chaves F. Bacteraemia due to extensively drug-resistant Pseudomonas aeruginosa sequence type 235 high-risk clone: Facing the perfect storm. Int J Antimicrob Agents 2018;52:172–9; 18. Spoletini G, Etherington C, Shaw N, et al. Use of ceftazidime/avibactam for the treatment of MDR Pseudomonas aeruginosa and Burkholderia cepacia complex infections in cystic fibrosis: a case series. J Antimicrob Chemother. 2019;74:1425–9; 19. Iannaccone M, Boattini M, Bianco G, Corcione S, Cavallo R, Costa C. Ceftazidime-avibactam susceptible to resistant KPC-producing Enterobacterales bloodstream infections: an observational study. J Chemother 2020;32:160–2; 20. Chen W, Sun L, Guo L, et al. Clinical outcomes of ceftazidime-avibactam in lung transplant recipients with infections caused by extensively drug-resistant gram-negative bacilli. Ann Transl Med 2020;8:39–51; 21 King M, Heil E, Kuriakose S, et al. Multicenter Study of Outcomes with Ceftazidime-Avibactam in Patients with Carbapenem-Resistant Enterobacteriaceae Infections. Antimicrob Agents Chemother 2017;61:e00449-17; 22. Jorgensen SCJ, Trinh TD, Zasowski EJ, et al. Real-World Experience With Ceftazidime-Avibactam for Multidrug-Resistant Gram-Negative Bacterial Infections. Open Forum Infect Dis 2019;6:ofz522; 23. Bassetti M, Carannante N2, Pallotto C, et al. KPC-producing Klebsiella pneumoniae gut decolonisation following ceftazidime/avibactam-based combination therapy: A retrospective observational study. J Glob Antimicrob Resist 2019;17:109–11; 24. Tsolaki V, Mantzarlis K, Mpakalis A, et al. Ceftazidime-Avibactam To Treat Life-Threatening Infections by Carbapenem-Resistant Pathogens in Critically Ill Mechanically Ventilated Patients. Antimicrob Agents Chemother 2020;64:e02320-9; 25. Jorgensen SC, Murray KP, Lagnf AM, et al. A Multicenter Evaluation of Vancomycin-Associated Acute Kidney Injury in Hospitalized Patients with Acute Bacterial Skin and Skin Structure Infections. Infect Dis Ther. 2020;9(1):89-106. 26. Ackley R, Roshdy D, Meredith J, et al. Meropenem-Vaborbactam versus Ceftazidime-Avibactam for Treatment of Carbapenem-Resistant Enterobacteriaceae Infections. Antimicrob Agents Chemother 2020;64:e02313-19; 27. Strich, JR. Pharmacoepidemiology of Ceftazidime-Avibactam Use: A Retrospective Cohort Analysis of 210 US Hospitals. Clin Infect Dis. 2020:10:1093; 28. Vena A, Giacobbe D,,Castaldo N, et al. Clinical Experience with Ceftazidime-Avibactam for the Treatment of Infections due to Multidrug-Resistant Gram-Negative Bacteria Other than Carbapenem-Resistant Enterobacterales. Antibiotics. 2020;9:10:3390; 29. Guimarães T, Nouér SA, Martins RCR, et al. Ceftazidime-Avibactam as Salvage Therapy for Infections Caused by Enterobacteriales Coresistant to Carbapenems and Polymyxins. Antimicrob Agents Chemother. 2019;63:e00528-19; 30. Falcone M, Bassetti M, Tiseo G, et al. Time to appropriate antibiotic therapy is a predictor of outcome in patients with bloodstream infection caused by KPC-producing Klebsiella pneumoniae. Crit Care. 2020;24:29–41.
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