Eravacycline for the treatment of complicated intra-abdominal infections

References

• Montravers P, Blot S, Dimopoulos G, et al. Therapeutic management of peritonitis: a comprehensive guide for intensivists. Intensive Care Med. 2016;42(8):1234–1247.
   PubMed Web of Science ®Google Scholar
• Montravers P, Tashk P, Tran Dinh A. Unmet needs in the management of intra-abdominal infections. Exp Rev Anti Infect Ther. 2017;15(9):839–850.
   PubMed Web of Science ®Google Scholar
• Lucasti C, Hershberger E, Miller B, et al. Multicenter, double-blind, randomized, phase II trial to assess the safety and efficacy of ceftolozane-tazobactam plus metronidazole compared with meropenem in adult patients with complicated intra-abdominal infections. Antimicrob Agents Chemother. 2014;58(9):5350–5357.
   PubMed Web of Science ®Google Scholar
• Solomkin J, Hershberger E, Miller B, et al. Ceftolozane/tazobactam plus metronidazole for complicated intra-abdominal infections in an era of multidrug resistance: results from a randomized, double-blind, phase 3 trial (ASPECT-cIAI). Clin Infect Dis. 2015;60(10):1462–1471.
   PubMed Web of Science ®Google Scholar
• Lucasti C, Vasile L, Sandesc D, et al. Phase 2, dose-ranging study of relebactam with imipenem-cilastatin in subjects with complicated intra-abdominal infection. Antimicrob Agents Chemother. 2016;60(10):6234–6243.
   PubMed Web of Science ®Google Scholar
• Mazuski JE, Gasink LB, Armstrong J, et al. Efficacy and safety of ceftazidime-avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infection: results from a randomized, controlled, double-blind, phase 3 program. Clin Infect Dis. 2016;62(11):1380–1389.
   PubMed Web of Science ®Google Scholar
• Qin X, Tran BG, Kim MJ, et al. A randomised, double-blind, phase 3 study comparing the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem for complicated intra-abdominal infections in hospitalised adults in Asia. Int J Antimicrob Agents. 2017;49(5):579–588.
   PubMed Web of Science ®Google Scholar
• Carmeli Y, Armstrong J, Laud PJ, et al. Ceftazidime-avibactam or best available therapy in patients with ceftazidime-resistant Enterobacteriaceae and Pseudomonas aeruginosa complicated urinary tract infections or complicated intra-abdominal infections (REPRISE): a randomised, pathogen-directed, phase 3 study. Lancet Infect Dis. 2016;16(6):661–673.
   PubMed Web of Science ®Google Scholar
• Motsch J, Murta de Oliveira C, Stus V, et al. RESTORE-IMI 1: a multicenter, randomized, double-blind trial comparing efficacy and safety of imipenem/relebactam vs colistin plus imipenem in patients with imipenem-nonsusceptible bacterial infections. Clin Infect Dis. 2019 Aug 10:ciz530. doi: 10.1093/cid/ciz530. Epub ahead of print.
   PubMedGoogle Scholar
• Sartelli M, Catena F, Ansaloni L, et al. Complicated intra-abdominal infections worldwide: the definitive data of the CIAOW Study. World J Emerg Surg. 2014;9:37.
   PubMed Web of Science ®Google Scholar
• Blot S, Antonelli M, Arvaniti K, et al. Epidemiology of intra-abdominal infection and sepsis in critically ill patients: « AbSeS », a multinational observational cohort study and ESICM trials group project. Intensive Care Med submit.
   Google Scholar
• Wright H, Bonomo RA, Paterson DL. New agents for the treatment of infections with Gram-negative bacteria: restoring the miracle or false dawn? Clin Microbiol Infect. 2017;23(10):704–712.
   PubMed Web of Science ®Google Scholar
• Talbot GH, Jezek A, Murray BE, et al. The infectious diseases society of America’s 10 x ‘20 initiative (ten new systemic antibacterial agents FDA-approved by 2020): is 20 x ‘20 a possibility? Clin Infect Dis. 2019;69(1):1–11.
   PubMed Web of Science ®Google Scholar
• Abdul-Aziz MH, Lipman J, Mouton JW, et al. Applying pharmacokinetic/pharmacodynamic principles in critically ill patients: optimizing efficacy and reducing resistance development. Semin Respir Crit Care Med. 2015;36(1):136–153.
   PubMed Web of Science ®Google Scholar
• Boidin C, Moshiri P, Dahyot-Fizelier C, et al. Pharmacokinetic variability of beta-lactams in critically ill patients: a narrative review. Anaesth Crit Care Pain Med. 2019 Sep 9:S2352-5568(19)30138–9. doi: 10.1016/j.accpm.2019.07.016. Epub ahead of print.
   PubMedGoogle Scholar
• Buijk SL, Gyssens IC, Mouton JW. et al. Pharmacokinetics of ceftazidime in serum and peritoneal exudate during continuous versus intermittent administration to patients with severe intra-abdominal infections. J Antimicrob Chemother. 2002;49(1):121–128.
   PubMed Web of Science ®Google Scholar
• Dahyot-Fizelier C, Lefeuvre S, Laksiri L, et al. Kinetics of imipenem distribution into the peritoneal fluid of patients with severe peritonitis studied by microdialysis. Clin Pharmacokinet. 2010;49(5):323–334.
   PubMed Web of Science ®Google Scholar
• Li J, Lovern M, Green ML, et al. Ceftazidime-avibactam population pharmacokinetic modeling and pharmacodynamic target attainment across adult indications and patient subgroups. Clin Transl Sci. 2019;12(2):151–163.
   PubMed Web of Science ®Google Scholar
• Xiao AJ, Huntington JA, Long J, et al. Ceftolozane/tazobactam dose regimens in severely/morbidly obese patients with complicated intra-abdominal infection or complicated urinary tract infection. Int J Antimicrob Agents. 2018;52(3):324–330.
   PubMed Web of Science ®Google Scholar
• Harper NJN, Cook TM, Garcez T, et al. Anaesthesia, surgery, and life-threatening allergic reactions: epidemiology and clinical features of perioperative anaphylaxis in the 6th National Audit Project (NAP6). Br J Anaesth. 2018;121(1):159–171.
   PubMed Web of Science ®Google Scholar
• Tacquard C, Collange O, Gomis P, et al. Anaesthetic hypersensitivity reactions in France between 2011 and 2012: the 10th GERAP epidemiologic survey. Acta Anaesthesiol Scand. 2017;61(3):290–299.
   PubMed Web of Science ®Google Scholar
• Eckmann C. Antimicrobial therapy of intra-abdominal infections in the era of multiresistance. Chirurg. 2016;87(1):26–33.
   PubMed Web of Science ®Google Scholar
• Montravers P, Dupont H, Leone M, et al. Guidelines for management of intra-abdominal infections. Anaesth Crit Care Pain Med. 2015;34(2):117–130.
   PubMed Web of Science ®Google Scholar
• Mazuski JE, Tessier JM, May AK, et al. The Surgical Infection Society revised guidelines on the management of intra-abdominal infection. Surg Infect (Larchmt). 2017;18(1):1–76.
   PubMed Web of Science ®Google Scholar
• Sartelli M, Catena F, FM A-Z, et al. Management of intra-abdominal infections: recommendations by the WSES 2016 consensus conference. World J Emerg Surg. 2017;12:22.
   PubMed Web of Science ®Google Scholar
• Rodriguez-Bano J, Gutierrez-Gutierrez B, Machuca I, et al. Treatment of infections caused by extended-spectrum-Beta-lactamase-, AmpC-, and carbapenemase-producing Enterobacteriaceae. Clin Microbiol Rev. 2018;31(2):e00079–17.
   PubMed Web of Science ®Google Scholar
• Cunha BA, Baron J, Cunha CB. Once daily high dose tigecycline - pharmacokinetic/pharmacodynamic based dosing for optimal clinical effectiveness: dosing matters, revisited. 2017;15(3):257–267. Exp Rev Anti Infect Ther.
   PubMed Web of Science ®Google Scholar
• Abbas M, Paul M, Huttner A. New and improved? A review of novel antibiotics for Gram-positive bacteria. Clin Microbiol Infect. 2017;23(10):697–703.
   PubMed Web of Science ®Google Scholar
• Zhanel GG, Cheung D, Adam H, et al. Review of eravacycline, a novel fluorocycline antibacterial agent. Drugs. 2016;76(5):567–588.
   PubMed Web of Science ®Google Scholar
• Scott LJ. Eravacycline: A review in complicated intra-abdominal infections. Drugs. 2019;79(3):315–324.
   PubMed Web of Science ®Google Scholar
• Mohd Sazlly Lim S, FB S, Roberts J. Multidrug-resistant Acinetobacter baumannii infections: current evidence on treatment options and role of PK/PD in dose optimization. Int J Antimicrob Agents. 2019;53(6):726–745.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Xerava (Eravacycline): assessment report; 2018 [cited 2019 May 15th. Available from: [https://www.ema.europa.eu/en/documents/assessment-report/xerava-epar-public-assessment-report_en.pdf]
   Google Scholar
• Zhanel GG, Baxter MR, Adam HJ, et al. In vitro activity of eravacycline against 2213 Gram-negative and 2424 Gram-positive bacterial pathogens isolated in Canadian hospital laboratories: CANWARD surveillance study 2014–2015. Diagn Microbiol Infect Dis. 2018;91(1):55–62.
   PubMed Web of Science ®Google Scholar
• Morrisey I, Kothari N, Monti F, et al. In vitro activity of eravacycline and comparators against Gram-positive bacteria collected from European hospitals in 2017. P1874. Presented at: 29th European Congress of Clinical Microbiology and Infectious Diseases; 2019 April 13th; Amsterdam.
   Google Scholar
• Hawser S, Kothari N, Monti F, et al. Surveillance of the in vitro activity of eravacycline and comparators against clinical isolates from Europe during 2017. P1875. Presented at: 29th European Congress of Clinical Microbiology and Infectious Diseases; 2019 April 13th; Amsterdam.
   Google Scholar
• Morrisey I, Bassetti M, Magnet S, et al., editors. In vitro activity of eravacycline and comparators against Acinetobacter baumanii, Stenotrophomonas maltophilia and Enterobacteriaceae, including carbapenem-resistant and ESBL phenotype subgroups, collected from European hospitals in 2015. Poster #P1260. Presented at: 27th European Congress of Clinical Microbiology and Infectious Diseases; 2017 April 22nd; Vienna.
   Google Scholar
• Livermore DM, Mushtaq S, Warner M. et al. In vitro activity of eravacycline against carbapenem-resistant Enterobacteriaceae and Acinetobacter baumannii. Antimicrob Agents Chemother. 2016;60(6):3840–3844.
   PubMed Web of Science ®Google Scholar
• Seifert H, Stefanik D, Sutcliffe JA, et al. In-vitro activity of the novel fluorocycline eravacycline against carbapenem non-susceptible Acinetobacter baumannii. Int J Antimicrob Agents. 2018;51(1):62–64.
   PubMed Web of Science ®Google Scholar
• Fyfe C, LeBlanc G, Close B. et al. Eravacycline is active against bacterial isolates expressing the polymyxin resistance gene mcr-1. Antimicrob Agents Chemother. 2016;60(11):6989–6990.
   PubMed Web of Science ®Google Scholar
• Newman J, Izmailyan S, Fyfe C, et al. Combined microbiological response rates from two phase 3 trials demontrating the activity of eravacycline in the treatment of complicated intra-abdominal infections: a pooled analysis of IGNITE1 and IGNITE4. Poster #1963. Presented at IDWeek; 2018; 2018 October 6th; San Francisco, CA
   Google Scholar
• Goldstein EJC, Citron DM, Tyrrell KL. In vitro activity of eravacycline and comparator antimicrobials against 143 recent strains of bacteroides and parabacteroides species. Anaerobe. 2018;52:122–124.
   PubMed Web of Science ®Google Scholar
• Snydman DR, McDermott LA, Jacobus NV, et al. Evaluation of the in vitro activity of eravacycline against a broad spectrum of recent clinical anaerobic isolates. Antimicrob Agents Chemother. 2018;62(5):e02206–17.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. Identified interpretative criteria for eravacycline 2018; 2019 [cited 2019 May 15th]. Available from: [https://www.fda.gov/drugs/development-resources/eravacycline-injection-products]
   Google Scholar
• European Committee on Antimicrobial Susceptibility Testing. EUCAST clinical breakpoints; 2019 [cited 2019 May 15th]. Available from: [http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Breakpoint_tables/v_9.0_Breakpoint_Tables.pdf]
   Google Scholar
• Grossman TH, Murphy TM, Slee AM, et al. Eravacycline (TP-434) is efficacious in animal models of infection. Antimicrob Agents Chemother. 2015;59(5):2567–2571.
   PubMed Web of Science ®Google Scholar
• Efimova E, Olesky M, Izmailyan S, et al. Pooled analysis of safety data from phase 2 and phase 3 clinical trials evaluating eravacycline in complicated intraabdominal infections. Poster #1976. Presented at ID week 2018; San Francisco, CA.
   Google Scholar
• US Food and Drug Administration. Xerava (eravacycline) package insert 2018; 2019 [cited 2019 May 15th]. Available from: [https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf]
   Google Scholar
• European Medicines Agency. Xerava (Eravacycline): summary of product characteristics 2018; 2019 [cited 2019 May 15]. Available from: [https://www.ema.europa.eu/en/documents/product-information/xerava-epar-product-information_en.pdf]
   Google Scholar
• Petraitis V, Petraitiene R, Maung BBW, et al. Pharmacokinetics and comprehensive analysis of the tissue distribution of eravacycline in rabbits. Antimicrob Agents Chemother. 2018;62(9):e00275–18.
   PubMed Web of Science ®Google Scholar
• Newman JV, Zhou J, Izmailyan S, et al. Mass balance and drug interaction potential of intravenous eravacycline administered to healthy subjects. Antimicrob Agents Chemother. 2019;63(3):e01810–18.
   PubMed Web of Science ®Google Scholar
• Solomkin JS, Ramesh MK, Cesnauskas G, et al. Phase 2, randomized, double-blind study of the efficacy and safety of two dose regimens of eravacycline versus ertapenem for adult community-acquired complicated intra-abdominal infections. Antimicrob Agents Chemother. 2014;58(4):1847–1854.
   PubMed Web of Science ®Google Scholar
• Solomkin J, Evans D, Slepavicius A, et al. Assessing the efficacy and safety of eravacycline vs ertapenem in complicated intra-abdominal infections in the investigating Gram-negative infections treated with eravacycline (IGNITE 1) trial: A randomized clinical trial. JAMA Surg. 2017;152(3):224–232.
   PubMed Web of Science ®Google Scholar
• Solomkin JS, Gardovskis J, Lawrence K, et al. IGNITE4: results of a phase 3, randomized, multicenter, prospective trial of eravacycline vs. meropenem in the treatment of complicated intra-abdominal infections. Clin Infect Dis. 2019;69(6):921–929.
   PubMed Web of Science ®Google Scholar
• Lawrence K, Mathias E, Olesky M, et al. A post-hoc evaluation of the length of antibiotic therapy from IGNITE4: A phase 3 study of eravacycline and meropenem for complicated intraabdominal infections. Presented at: 38th Surgical Infection Society annual meeting; 2018; 2018 April 22nd; Westlake Village, CA
   Google Scholar
• Fonte A, Kolkin S, Lawrence K, et al. Efficacy of eravacycline in obese patients: pooled analysis of IGNITE 1 and IGNITE 4. Poster #48219. Presented at: ACCP Global Conference on Clinical Pharmacy; 2018 October 23rd; Seattle, WA.
   Google Scholar
• Kolkin S, Fonte A, Lawrence K, et al. Effect of renal function in IGNITE 1 and IGNITE 4: two phase 3 studies to evaluate the efficacy and safety of eravacycline. Poster #48211. ACCP Global Conference on Clinical Pharmacy; 2018 October 23rd; Seattle, WA.
   Google Scholar
• Demuth J, Lawrence K, Izmailyan S, et al. Efficacy of eravacycline in secondary bacteremia: A post hoc analysis of two phase 3 studies of complicated intra-abdominal infection. Poster#1978. Presented at: ID week 2018; 2018 October 6th; San Francisco, CA
   Google Scholar
• Montravers P, Tubach F, Lescot T, et al. Short-course antibiotic therapy for critically ill patients treated for postoperative intra-abdominal infection: the DURAPOP randomised clinical trial. Intensive Care Med. 2018;44(3):300–310.
   PubMed Web of Science ®Google Scholar
• Broeker A, Wicha SG, Dorn C, et al. Tigecycline in critically ill patients on continuous renal replacement therapy: a population pharmacokinetic study. Crit Care. 2018;22(1):341.
   PubMedGoogle Scholar
• Eckmann C, Montravers P, Bassetti M, et al. Efficacy of tigecycline for the treatment of complicated intra-abdominal infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013;68(Suppl 2):25–35.
   Google Scholar