Eravacycline for the treatment of intra-abdominal infections

Expert Opinion on Investigational Drugs

Volumn 23, Issue 11, 2014, Pages 1575-1584

  Bassetti, Matteo ^a   Righi, Elda ^a  

^a SANTA MARIA DELLA MISERICORDIA UNIVERSITY HOSPITAL   (Italy)

Author keywords

Abdominal infections; Bacteria; Eravacycline; New antibiotics

Indexed keywords

ANTIINFECTIVE AGENT; CARBAPENEM DERIVATIVE; ERAVACYCLINE; ERTAPENEM; EXTENDED SPECTRUM BETA LACTAMASE; TETRACYCLINE DERIVATIVE; 7-FLUORO-9-PYRROLIDINOACETAMIDO-6-DEMETHYL-6-DEOXYTETRACYCLINE; BETA LACTAM;

ABDOMINAL INFECTION; ARTICLE; CARBAPENEM RESISTANT ENTEROBACTERIACEAE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG METABOLISM; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; GRAM NEGATIVE BACTERIUM; GRAM POSITIVE BACTERIUM; HOSPITAL INFECTION; HUMAN; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS; MICROBIOLOGY; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); URINARY TRACT; URINARY TRACT INFECTION; VANCOMYCIN RESISTANT ENTEROCOCCUS; ANIMAL; COMPARATIVE STUDY; GRAM-NEGATIVE BACTERIAL INFECTIONS; GRAM-POSITIVE BACTERIAL INFECTIONS; INTRAABDOMINAL INFECTIONS; MICROBIAL SENSITIVITY TEST; MULTIDRUG RESISTANCE; ORAL DRUG ADMINISTRATION;

ADMINISTRATION, ORAL; ANIMALS; ANTI-BACTERIAL AGENTS; BETA-LACTAMS; DRUG RESISTANCE, MULTIPLE, BACTERIAL; GRAM-NEGATIVE BACTERIAL INFECTIONS; GRAM-POSITIVE BACTERIAL INFECTIONS; HUMANS; INTRAABDOMINAL INFECTIONS; MICROBIAL SENSITIVITY TESTS; TETRACYCLINES;

EID: 84911871699     PISSN: 13543784     EISSN: 17447658     Source Type: Journal    
DOI: 10.1517/13543784.2014.965253     Document Type: Article

References (63)

1. Boucher HW, Talbot GH, Bradley JS, et al. Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America. Clin Infect Dis 2009;48:1-12
2. Hersh AL, Newland JG, Beekmann SE, et al. Unmet medical need in infectious diseases. Clin Infect Dis 2012;54:1677-8
3. Sanchez-Pescador R, Brown JT, Roberts M, Urdea MS. Homology of the TetM with translational elongation factors: implications for potential modes of tetM-conferred tetracycline resistance. Nucleic Acids Res 1988;16:1218
4. Kanj SS, Kanafani ZA. Current concepts in antimicrobial therapy against resistant gram-negative organisms: extendedspectrum beta-lactamase-producing Enterobacteriaceae, carbapenem-resistant Enterobacteriaceae, and multidrugresistant Pseudomonas aeruginosa. Mayo Clin Proc 2011;86:250-9
5. Gupta N, Limbago BM, Patel JB, Kallen AJ. Carbapenem-resistant Enterobacteriaceae: epidemiology and prevention. Clin Infect Dis 2011;53:60-7
6. Munoz-Price LS, Poirel L, Bonomo RA, et al. Clinical epidemiology of the global expansion of Klebsiella pneumoniae carbapenemases. Lancet Infect Dis 2013;13:785-96
7. Correa L, Martino MD, Siqueira I, et al. A hospital-based matched case-control study to identify clinical outcome and risk factors associated with carbapenemresistant Klebsiella pneumoniae infection. BMC Infect Dis 2013;13:80
8. Nordmann P, Cuzon G, Naas T. The real threat of Klebsiella pneumoniae carbapenemase-producing bacteria. Lancet Infect Dis 2009;9:228-36
9. Peleg AY, Hooper DC. Hospital-acquired infections due to gram-negative bacteria. N Engl J Med 2010;362:1804-13
10. Qureshi ZA, Paterson DL, Peleg AY, et al. Clinical characteristics of bacteraemia caused by extended-spectrum beta-lactamase-producing Enterobacteriaceae in the era of CTX-M-type and KPC-type beta-lactamases. Clin Microbiol Infect 2012;18:887-93
11. Sunenshine RH, Wright MO, Maragakis LL, et al. Multidrug-resistant Acinetobacter infection mortality rate and length of hospitalization. Emerg Infect Dis 2007;13:97-103
12. Nelson ML, Levy SB. The history of the tetracyclines. Ann N Y Acad Sci 2011;1241:17-32
13. Charest MG, Lerner CD, Brubaker JD, et al. A convergent enantioselective route to structurally diverse 6-deoxytetracycline antibiotics. Science 2005;308:395-8
14. Wright PM, Seiple IB, Myers AG. The evolving role of chemical synthesis in antibacterial drug discovery. Angew Chem Int Ed Engl 2014;53:8840-69
15. Xiao XY, Hunt DK, Zhou J, et al. Fluorocyclines. 1. 7-fluoro-9- pyrrolidinoacetamido-6-demethyl-6-deoxytetracycline: a potent, broad spectrum antibacterial agent. J Med Chem 2012;55:597-605
16. Hunt D, Xiao X, Clark R, et al. TP-434 is a novel broad-spectrum fluorocycline. Presented at 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; 12 - 15 September 2010; Boston, MA, USA
17. Chopra I. Glycylcyclines: thirdgeneration tetracycline antibiotics. Curr Opin Pharmacol 2001;1:464-9
18. Roberts MC. Update on acquired tetracycline resistance genes. FEMS Microbiol Lett 2005;245:195-203
19. Burdett V. Tet(M)-promoted release of tetracycline from ribosomes is GTP dependent. J Bacteriol 1996;178:3246-51
20. Connell SR, Tracz DM, Nierhaus KH, Taylor DE. Ribosomal protection proteins and their mechanism of tetracycline resistance. Antimicrob Agents Chemother 2003;47:3675-81
21. Connell SR, Trieber CA, Dinos GP, et al. Mechanism of Tet(O)-mediated tetracycline resistance. EMBO J 2003;22:945-53
22. Sanchez GV, Master RN, Clark RB, et al. Klebsiella pneumoniae antimicrobial drug resistance, United States, 1998-2010. Emerg Infect Dis 2013;19:133-6
23. Thaker M, Spanogiannopoulos P, Wright GD. The tetracycline resistome. Cell Mol Life Sci 2010;67:419-31
24. Bryan A, Shapir N, Sadowsky MJ. Frequency and distribution of tetracycline resistance genes in genetically diverse, nonselected, and nonclinical Escherichia coli strains isolated from diverse human and animal sources. Appl Environ Microbiol 2004;70:2503-7
25. Peterson LR. A review of tigecycline, the first glycylcycline. Int J Antimicrob Agents 2008;32(Suppl 4):S215-22
26. Grossman TH, Starosta AL, Fyfe C, et al. Target- and resistance-based mechanistic studies with TP-434, a novel fluorocycline antibiotic. Antimicrob Agents Chemother 2012;56:2559-64
27. Tuckman M, Petersen PJ, Projan SJ. Mutations in the interdomain loop region of the tetA(A) tetracycline resistance gene increase efflux of minocycline and glycylcyclines. Microb Drug Resist 2000;6:277-82
28. Fyfe C, Sutcliffe J, Grossman TH. Susceptibility of tetracyclines to Tet(A) resistance is independent of interdomain loop sequence. Antimicrob Agents Chemother 2013;57:2430-1
29. Draper MP, Weir S, Macone A, et al. Mechanism of action of the novelaminomethylcycline antibiotic omadacycline. Antimicrob Agents Chemother 2014;58:1279-83
30. Macone AB, Caruso BK, Leahy RG, et al. In vitro and in vivo antibacterial activities of omadacycline, a novel aminomethylcycline. Antimicrob Agents Chemother 2014;58:1127-35
31. Clark RB, Hunt DK, He M, et al. Fluorocyclines. 2. Optimization of the C-9 side-chain for antibacterial activity and oral efficacy. J Med Chem 2012;55:606-22
32. Sutcliffe JA, O'Brien W, Fyfe C, Grossman TH. Antibacterial activity of eravacycline (TP-434), a novel fluorocycline, against hospital and community pathogens. Antimicrob Agents Chemother 2013;57:5548-58
33. Grossman TH, O'Brien WO, Fyfe C, Sutcliffe JA. Eravacycline is potent against third generation cephalosporinand carbapenem-resistant Enterobacteriaceae, carbapenem-resistant Acinetobacter baumannii, and has isolatespecific bactericidal activity [abstract C-1374]. 54th Annual ICAAC; 5 - 9 September 2014
34. McAleese F, Petersen P, Ruzin A, et al. A novel MATE family efflux pump contributes to the reduced susceptibility of laboratory-derived Staphylococcus aureus mutants to tigecycline. Antimicrob Agents Chemother 2005;49:1865-71
35. European Committee on Antimicrobial Susceptibility Testing, Breakpoint tables for interpretation of MICs and zone diameters, Version 3.1, 2013. Available from: http://www.eucast.org/clinical-breakpoints [Accessed 10 July 2014]
36. Clinical and Laboratory Standards Institute. Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically, approved standard. 11th edition. Document M7-A8 Clinical and Laboratory Standards Institute; Wayne, PA, USA: 2012
37. O'Brien W, Sutcliffe J, Grossman T. TP-434 is Synergistic in vitro with amphotericin B, fluconazole and caspofungin against Candida spp. Presented at 51th Annual Interscience Conference on Antimcrobial Agents and Chemotherapy; 17 - 20 September 2011; Chicago, IL, USA
38. Ronn M, Dunwoody N, Sutcliffe J. Pharmacokinetics of TP-434 in mouse, rat, dog, monkey and chimpanzee. Presented at 50th Annual Interscience Conference on Antimcrobial Agents and Chemotherapy; 12 - 15 September 2010; Boston, MA, USA
39. Sutcliffe J. Antibiotics in development targeting protein synthesis. Ann N Y Acad Sci 2011;1241:122-52
40. Singh RSP, Falcao NMS, Sutcliffe J, Derendorf H. Plasma protein binding of eravacycline in mouse, rat, rabbit, cynomolgus monkey, African green monkey and human using microdialysis [abstract A-015]. 53rd Annual ICAAC; 10 - 13 September 2013
41. Petersen PJ, Jacobus NV, Weiss WJ, et al. In vitro and in vivo antibacterial activities of a novel glycylcycline, the 9-t-butylglycylamido derivative of minocycline (GAR-936). Antimicrob Agents Chemother 1999;43:738-44
42. Yue CS, Sutcliffe JA, Colucci P, et al. Population pharmacokinetic modeling of TP-434, a novel fluorocycline, following single and multiple dose administration. Presented at 50th Annual Interscience Conference on Antimcrobial Agents and Chemotherapy; 12 - 15 September 2010; Boston, MA, USA
43. Horn P, Sutcliffe J, Walpole S, Leighton A. Pharmacokinetics, safety, and tolerability of a novel fluorocycline, TP-434, following multiple dose administration. Presented at 49th Meeting of the Infectious Disease Society of America; 20 - 23 October 2011; Boston, MA, USA
44. Leighton A, Zupanets I, Bezugla N, et al. Broad-spectrum fluorocycline TP-434 has oral bioavailability in humans. Presented at 21st European Congress of Clinical Microbiology and Infectious Diseases; 7 - 10 May 2011; Milan, Italy
45. Christ D, Sutcliffe J. TP-434 is metabolically stable and has low potential for drug-drug interactions [abstract F1-2162]. 50th annual ICAAC; 12 - 15 September 2010; Boston, MA
46. Cunha BA. Pharmacokinetic considerations regarding tigecycline for multidrug-resistant (MDR) Klebsiella pneumoniae or MDR Acinetobacter baumannii urosepsis. J Clin Microbiol 2009;47:1613
47. Sutcliffe J, Grossman T, Ronn M, et al. TP-434 has potential to treat complicated urinary tract infections (cUTI). Presented at 51th Annual Interscience Conference on Antimcrobial Agents and Chemotherapy; 17 - 20 September 2011; Chicago, IL, USA
48. O'Brien W, Sutcliffe J, Grossman T. Eravacycline (TP-434) is active in vitro against biofilms formed by uropathogenic Escherichia coli. Presented at 52th Annual Interscience Conference on Antimcrobial Agents and Chemotherapy; 9 - 12 September 2012; San Francisco, CA, USA
49. Labthavikul P, Petersen PJ, Bradford PA. In vitro activity of tigecycline against Staphylococcus epidermidis growing in an adherent-cell biofilm model. Antimicrob Agents Chemother 2003;47:3967-9
50. Raad I, Hanna H, Jiang Y, et al. Comparative activities of daptomycin, linezolid, and tigecycline against catheterrelated methicillin-resistant Staphylococcus bacteremic isolates embedded in biofilm. Antimicrob Agents Chemother 2007;51:1656-60
51. McConeghy KW, LaPlante KL. In vitro activity of tigecycline in combination with gentamicin against biofilm-forming Staphylococcus aureus. Diagn Microbiol Infect Dis 2010;68:1-6
52. Szezuka E, Kaznowsky A. Antimicrobial activity of tigecycline alone or in combination with rifampin againststaphylococcus epidermidis in biofilm. Folia Microbiol (Praha) 2014;59:283-8
53. Connors KP, Housman ST, Pope JS, et al. Phase I, open-label, safety and pharmacokinetic study to assess bronchopulmonary disposition of intravenous eravacycline in healthy men and women. Antimicrob Agents Chemother 2014;58:2113-18
54. Fyfe C, Grossman T, O'Brien W, et al. The novel broad spectrum fluorocycline TP434 is active against MDR gram negative pathogens. Presented at 21st European Congress of Clinical Microbiology and Infectious Diseases; 7 - 10 May 2011; Milan, Italy
55. Murphy T, Slee A, Sutcliffe J. TP-434 is highly efficacious in animal models of infection. Presented at 50th Annual Interscience Conference on Antimcrobial Agents and Chemotherapy; 12 - 15 September 2010; Boston, MA, USA
56. Solomkin JS, Mazuski JE, Bradley JS, et al. Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Clin Infect Dis 2010;50:133-64
57. 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 intraabdominal infections. Antimicrob Agents Chemother 2014;58:1847-54
58. Namias N, Solomkin JS, Jensen EH, et al. Randomized, multicenter, doubleblind study of efficacy, safety, and tolerability of intravenous ertapenem versus piperacillin/tazobactam in treatment of complicated intra-abdominal infections in hospitalized adults. Surg Infect (Larchmt) 2007;8:15-28
59. Sutcliffe J, Ronn M, Leighton A, et al. Phase 1 single ascending dose study of a broad-spectrum fluorocycline, TP-434.
60. Sutcliffe J, Ronn M, Leighton A, Sprenger C. Phase 1 single and multiple ascending dose studies of a broadspectrum fluorocycline, TP-434 [abstract A1-027]. 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy; 12 - 15 September 2010
61. Babinchak T, Ellis-Grosse E, Dartois N, et al. 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
62. Horn PT, Redican S, Wei X, et al. Eravacycline does not prolong corrected QT intervals in a thorough QT study conducted in healthy subjects. Presented at 24th European Congress of Clinical Microbiology and Infectious Diseases; 10 - 13 May 2014; Barcelona, Spain
63. Carbapenemase-producing bacteria in Europe. Interim results from the European survey on carbapenemaseproducing Enterobacteriaceae (EuSCAPE) project. 2013. Available from: www.ecdc.europa.eu.