Abstract
The emergence and spread of resistance to multiple classes of antimicrobials is a growing threat, especially in microorganisms causing severe nosocomial infections in hospital settings. Tigecycline, the first in a new class of antimicrobials (glycylcyclines), takes a special place among newly introduced antimicrobial agents. Tigecycline is active against many Gram-positive and Gram-negative pathogens, including strains resistant to other classes of antimicrobials. This paper represents main data on spectrum of activity, pharmacokinetics and pharmacodynamics, clinical efficacy, safety, and tolerability of tigecycline and, therefore, its role in a current clinical practice.
-
1.
Livermore D.M. Has the era of untreatable infections arrived? J Antimicrob Chemother 2009; 64(Suppl 1):i29- 36.
-
2.
Тигацил. Официальная информация о препарате компании Pfizer. http://www.pfizer.ru/activity/?id=30&n=485.
-
3.
Rubinstein E., Vaughan D. Tigecycline: a novel glycylcycline. Drugs 2005; 65(10): 1317-36.
-
4.
Bergeron J., Ammirati M., Danley D., et al. Glycylcyclines bind to the high-affinity tetracycline ribosomal binding site and evade tet(M)- and tet(O)-mediated ribosomal protection. Antimicrob Agents Chemother 1996; 40(9):2226-8.
-
5.
Bauer G., Berens C., Projan S.J., et al. Comparison of tetracycline and tigecycline binding to ribosomes mapped by dimethyl-sulphate and drug-directed Fe(2+) cleavage of 16S rRNA. J Antimicrob Chemother 2004; 53(4):592-9.
-
6.
Gales A.C., Jones R.N. Antimicrobial activity and spectrum of the new glycylcycline, GAR-936 tested against 1,203 recent clinical bacterial isolates. Diagn Microbiol Infect Dis 2000; 36(1):19-36.
-
7.
Biedenbach D.J., Beach M.L., Jones R.N. In vitro antimicrobial activity of GAR-936 tested against antibioticresistant gram-positive blood stream infection isolates and strains producing extended spectrum beta-lactamases. Diagn Microbiol Infect Dis 2001; 40(4):173-7.
-
8.
Tafur J.D., Torres J.A., Correa A., et al. Multicenter evaluation of in vitro activity of tigecycline against carbapenemase producing gram negative isolates from Colombia (C1-3818); 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and Infectious Disease Society of America (IDSA) 46th Annual Meeting; Oct 25-28; Washington DC. 2008.
-
9.
Poole K. Efflux-mediated antimicrobial resistance. J Antimicrob Chemother 2005; 56(1):20-51.
-
10.
Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - 8th ed. Approved Standard, CLSI document M07-A8, CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898. January 2009.
-
11.
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests - 10th ed. Approved Standard, CLSI document M02-A10, CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898. January 2009.
-
12.
Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria - 7th ed. Approved Standard, CLSI document M11-A7, CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898. January 2007.
-
13.
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing - 19th Informational Supplement. Approved Standard, CLSI document M100-S19, CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898. January 2009.
-
14.
European Committee on Antimicrobial Susceptibility Testing (EUCAST). Breakpoint tables for interpretation of MICs and zone diameters. Version 1.0. December 2009. http://www.eucast.org/fileadmin/src/media/PDFs/EUCAST_files/Disk_test_documents/EUCAST_ breakpoints_v1.0_20091221.xls
-
15.
Pankey G.A. Tigecycline. J Antimicrob Chemother 2005; 56(3):470-80.
-
16.
Tedesco K.L., Huang V., Rybak M.J. In vitro activities of daptomycin, arbekacin & tigecycline (GAR-936) against several clinical glycopeptides intermediate Staphylococcus aureus (GISA) pathogens. In: Programs and Abstracts of the Forty-first Annual Meeting of the Infectious Diseases Society of America, San Diego, CA, 2003. Abstract 179, p. 58.
-
17.
Bozdogan B., Esel D., Whitener C. et al. Antibacterial susceptibility of a vancomycin-resistant Staphylococcus aureus strain isolated at the Hershey Medical Center. J Antimicrob Chemother 2003; 52:864-8.
-
18.
Labthavikul P., Petersen P.J., Bradford P.A. In vitro activity of tigecycline against Staphylococcus epidermidis growing in an adherent-cell biofilm model. Antimicrob Agents Chemother 2003; 47:3967-9.
-
19.
Fritsche T.R., Kirby J.T., Jones R.N. In vitro activity of tigecycline (GAR-936) tested against 11,859 recent clinical isolates associated with community-acquired respiratory tract and Gram-positive cutaneous infections. Diagn Microbiol Infect Dis 2004; 49:201-9.
-
20.
Patel R., Rouse M.S, Piper K.E. et al. In vitro activity of GAR-936 against vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae. Diagn Microbiol Infect Dis 2000; 38:177-9.
-
21.
Cercenado E., Cercenado S., Gomez J.A. et al. In vitro activity of tigecycline (GAR-936), a novel glycylcycline, against vancomycin resistant enterococci and staphylococci with diminished susceptibility to glycopeptides (letter). J Antimicrob Chemother 2003; 52:138-9.
-
22.
Mercier R.C., Kennedy C., Meadows C. Antimicrobial activity of tigecycline (GAR-936) against Enterococcus faecium and Staphylococcus aureus used alone and in combination. Pharmacotherapy 2002; 22:1517-23.
-
23.
Pachon-Ibanez M.E., Jimenez-Mejias M.E., Pichardo C. et al. Activity of tigecycline (GAR-936) against Acinetobacter baumannii strains, including those resistant to imipenem. Antimicrob Agents Chemother 2004; 48:4479-81.
-
24.
Seifert H., Stefanik D., Wisplinghoff H. Comparative in vitro activities of tigecycline and 11 other antimicrobial agents of nontraditional antimicrobials against 215 epidemiologically defined multidrug-resistant Acinetobacter baumannii isolates. J Antimicrob Chemother 2006; 58 (5):1099-100.
-
25.
Scheetz M.H., Qi C., Warren J.R., et al. In vitro activities of various antimicrobials alone and in combination with tigecycline against carbapenem-intermediate or -resistant Acinetobacter baumannii. Antimicrob Agents Chemother 2007; 51(5):1621-6.
-
26.
Souli M., Kontopidou F.V., Koratzanis E., et al. In vitro activity of tigecycline against multiple-drug-resistant, including pan-resistant, gram-negative and gram-positive clinical isolates from Greek hospitals. Antimicrob Agents Chemother 2006; 50(9):3166-9.
-
27.
Jacobus N.V., McDermott L.A., Ruthazer R. et al. In vitro activities of tigecycline against the Bacteroides fragilis group. Antimicrob Agents Chemother 2004; 48:1034-6.
-
28.
Edlund C., Nord C.E. In vitro susceptibility of anaerobic bacteria to GAR-936, a new glycylcycline. Clin Microbiol Infect 2000; 6:159-63.
-
29.
Betriu C., Rodriguez-Avial I., Sanchez B.A., et al; Spanish Group of Tigecycline. In vitro activities of tigecycline (GAR-936) against recently isolated clinical bacteria in Spain. Antimicrob Agents Chemother. 2002; 46:892-5.
-
30.
Goldstein E.J., Citron D.M., Merriam C.V., et al. Comparative in vitro activities of GAR-936 against aerobic and anaerobic animal and human bite wound pathogens. Antimicrob Agents Chemother 2000; 44:2747-51.
-
31.
Nagy E., Dowzicky M.J. In vitro activity of tigecycline and comparators against a European compilation of anaerobes collected as part of the Tigecycline Evaluation and Surveillance Trial (TEST). Scand J Infect Dis 2010; 42(1):33-8.
-
32.
Edelstein P.H., Weiss W.J., Edelstein M.A. Activities of tigecycline (GAR-936) against Legionella pneumophila in vitro and in guinea pigs with L.pneumophila pneumonia. Antimicrob Agents Chemother 2003; 7(2):533-40.
-
33.
Nørskov-Lauritsen N., Marchandin H., Dowzicky M.J. Antimicrobial susceptibility of tigecycline and comparators against bacterial isolates collected as part of the TEST study in Europe (2004-2007). Int J Antimicrob Agents 2009; 34(2):121-30.
-
34.
Dowzicky M.J., Park C.H. Update on antimicrobial susceptibility rates among gram-negative and gram-positive organisms in the United States: results from the Tigecycline Evaluation and Surveillance Trial (TEST) 2005 to 2007. Clin Ther 2008; 30(11):2040-50.
-
35.
van Ogtrop M.L., Andes D., Stamstad T.J., et al. In vivo pharmacodynamic activities of two glycylcyclines (GAR936 and WAY 152,288) against various gram-positive and gram-negative bacteria. Antimicrob Agents Chemother 2000; 44:943-9.
-
36.
Hoellman D.B., Pankuch G.A., Jacobs M.R., et al. Antipneumococcal activities of GAR-936 (a new glycylcycline) compared to those of nine other agents against penicillin-susceptible and -resistant pneumococci. Antimicrob Agents Chemother 2000; 44:1085-8.
-
37.
Nathwani D. Tigecycline: clinical evidence and formulary positioning. Int J Antimicrob Agents 2005; 25 (3):185- 92.
-
38.
Garrison M.W., Nuemiller J.J. In vitro activity of tigecycline against quinolone-resistant Streptococcus pneumoniae, methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci. Int J Antimicrob Agents 2007; 29:191-6.
-
39.
Muralidharan G., Micalizzi M., Speth J., et al. Pharmacokinetics of tigecycline after single and multiple doses in healthy subjects. Antimicrob Agents Chemother 2005; 49:220-9.
-
40.
Wyeth Pharmaceuticals Inc. Tygacil™ (tigecycline) for injection prescribing information [online]. Available from: http://www.wyeth.com/content/getfile.asp?id=474.
-
41.
Rodvold K.A., Gotfried M.H., Cwik M., et al. Serum, tissue and body fluid concentrations of tigecycline after a single 100 mg dose. J Antimicrob Chemother 2006; 58:1221-9.
-
42.
Muralidharan G., Fruncillo R.J., Micalizzi M., et al. Effects of age and sex on single-dose pharmacokinetics of tigecycline in healthy subjects. Antimicrob Agents Chemother 2005; 49:1656-9.
-
43.
Saunders S., Baird-Bellaire S.J., Patat A.A., et al. Pharmacokinetics of tigecycline (TGC) in patients with hepatic impairment. European Association for Clinical Pharmacology and Therapeutics; June 24-29; Poznan, Poland. 2005. meeting abstract.
-
44.
Mandell L.A., Wunderink R.G., Anzueto A., et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis 2007; 44(Suppl. 2):S27-72.
-
45.
Чучалин А.Г., Синопальников А.И., Страчунский Л.С. с соавт. Внебольничная пневмония у взрослых: практические рекомендации по диагностике, лечению и профилактике. Clinical Microbiology and Antimicrobial Chemotherapy.2006; 8(1):54-86.
-
46.
Tanaseanu C., Bergallo C., Teglia O., et al. Integrated results of 2 phase 3 studies comparing tigecycline and levofloxacin in community-acquired pneumonia. Diagn Microbiol Infect Dis 2008; 61(3):329-38.
-
47.
DiNubile M.J., Lipsky B.A. Complicated infections of skin and skin structures: when the infection is more than skin deep. J Antimicrobial Chemotherapy 2004; 53 (Suppl 2): ii37-50.
-
48.
Pulgar S., Mehra M., Quintana A., et al. The epidemiology of hospitalized cases of skin and soft tissue infection in Europe. Proceedings of the 18th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Barselona, Spain, 19-22 April 2008. Poster # P821.
-
49.
Kozlov R., Edelstain M., Kretchikova O., et al. Etiology of nosocomial bacterial infections in Russia. Proceedings of the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2008) (25-28 October 2008, Washington, DC, USA). Abstract # K-4108.
-
50.
Fritsche T.R., Sader H.S., Jones R.N. Potency and spectrum of garenoxacin tested against an international collection of skin and soft tissue infection pathogens: report from the SENTRY antimicrobial surveillance program (1999-2004). Diagn Microbiol Infect Dis 2007; 58(1):19- 26.
-
51.
Dekhnich A.V., Stratchounski L.S., Edelstein I.A. Antimicrobial resistance of nosocomial strains of S. aureus isolated from patients with skin and soft tissue infections in Russia. Proceedings of the 14th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), Prague, Czech Republic, 1-4 May, 2004. Poster #1353.
-
52.
Дехнич А.В., Эйдельштейн И.А., Нарезкина А.Д. с соавт. Эпидемиология антибиотикорезистентности нозокомиальных штаммов Staphylococcus aureus в России: результаты многоцентрового исследования. Clinical Microbiology and Antimicrobial Chemotherapy.2002; 4(4):325-36.
-
53.
Widmer A.F. Ceftobiprole: a new option for treatment of skin and soft-tissue infections due to methicillin-resistant Staphylococcus aureus. Clin Infect Dis 2008; 46(5):656-8.
-
54.
Ellis-Grosse E.J., Babinchak T., Dartois N., et al; Tigecycline 300 cSSSI Study Group; Tigecycline 305 cSSSI Study Group. The efficacy and safety of tigecycline in the treatment of skin and skin-structure infections: results of 2 double-blind phase 3 comparison studies with vancomycin-aztreonam. Clin Infect Dis 2005; 41(Suppl 5): S341-53.
-
55.
Dartois N. Results of a Phase 3, double-blind, safety and efficacy study comparing tigecycline with vancomycin/ aztreonam to treat complicated skin and skin structure infections. In: Programs and Abstracts of the Forty-fourth Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, 2004. Abstract L-986, p. 389. American Society for Microbiology, Washington, DC, USA.
-
56.
Sacchidanand S., Penn R.L., Embil J.M., et al. Efficacy and safety of tigecycline monotherapy compared with vancomycin plus aztreonam in patients with complicated skin and skin structure infections: Results from a phase 3, randomized, double-blind trial. Int J Infect Dis 2005; 9(5):251-61.
-
57.
Breedt J., Teras J., Gardovskis J., et al; Tigecycline 305 cSSSI Study Group. Safety and efficacy of tigecycline in treatment of skin and skin structure infections: results of a double-blind phase 3 comparison study with vancomycin-aztreonam. Antimicrob Agents Chemother 2005; 49(11):4658-66.
-
58.
Mallick R., Solomon S. The duration of hospitalization (length of stay) in patients hospitalized with complicated skin and skin structure infections: identifying clinical and microbiological risk factors in a comparison of tigecycline with vancomycin/aztreonam. 15th European Congress of Clinical Microbiology and Infectious Diseases; May 1-4, 2005; Prague, Czech Republic. Abstract P1181.
-
59.
Mazuski J.E., Solomkin J.S. Intra-abdominal infections. Surg Clin North Am 2009; 89(2):421-37.
-
60.
Wittmann D.H., Wittmann-Tylor A. Scope and limitations of antimicrobial therapy of sepsis in surgery. Arch Surg 1998; 383:15-25.
-
61.
Fomin P., Beuran M., Gradauskas A., et al. Three Hundred Six Study Group. Tigecycline is efficacious in the treatment of complicated intra-abdominal infections. Int J Surg 2005; 3(1):35-47.
-
62.
Oliva M.E., Rekha A., Yellin A., et al; 301 Study Group. A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections. BMC Infect Dis 2005; 5:88.
-
63.
Babinchak T., Ellis-Grosse E., Dartois N., et al; Tigecycline 301 Study Group; Tigecycline 306 Study Group. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections: analysis of pooled clinical trial data. Clin Infect Dis 2005; 41(Suppl 5):S354-67.
-
64.
Gardiner D., Dukart G., Cooper A., et al. Safety and efficacy of intravenous tigecycline in subjects with secondary bacteremia: pooled results from 8 phase III clinical trials. Clin Infect Dis 2010; 50(2):229-38.
-
65.
Vasilev K., Reshedko G., Orasan R, et al.; 309 Study Group. A Phase 3, open-label, non-comparative study of tigecycline in the treatment of patients with selected serious infections due to resistant Gram-negative organisms including Enterobacter species, Acinetobacter baumannii and Klebsiella pneumoniae. J Antimicrob Chemother. 2008; 62(Suppl 1):i29-40.
-
66.
Florescu I., Beuran M., Dimov R., et al; 307 Study Group. Efficacy and safety of tigecycline compared with vancomycin or linezolid for treatment of serious infections with methicillin-resistant Staphylococcus aureus or vancomycin-resistant enterococci: a Phase 3, multicentre, doubleblind, randomized study. J Antimicrob Chemother 2008; 62(Suppl 1):i17-28.