Therapy of 1,025 severely ill patients with complicated infections in a german multicenter study: Safety profile and efficacy of tigecycline in different treatment modalities

Chemotherapy

Volumn 58, Issue 4, 2012, Pages 282-294

  Bodmann, Klaus Friedrich ^a   Heizmann, Wolfgang R ^b   Von Eiff, Christof ^c   Petrik, Christian ^c   Löschmann, Peter Andreas ^c   Eckmann, Christian ^d  

^a Klinikum Barnim GmbH   (Germany)

^b Center of Microbiology and Infectiology   (Germany)

^c PFIZER INC   (United States)

^d Klinikum Peine   (Germany)

Author keywords

Complicated infections; Intra abdominal infections; Non interventional study; Safety profile; Skin soft tissue infections; Tigecycline; Treatment modality

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTIBIOTIC AGENT; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; C REACTIVE PROTEIN; GAMMA GLUTAMYLTRANSFERASE; IMMUNOSUPPRESSIVE AGENT; TIGECYCLINE;

ABDOMINAL INFECTION; ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; AGED; ANOREXIA; ANTIBIOTIC THERAPY; APACHE; ARTICLE; BACTERIAL INFECTION; BACTERIAL PERITONITIS; CHEMOTHERAPY INDUCED EMESIS; COMBINATION CHEMOTHERAPY; CRITICALLY ILL PATIENT; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG FATALITY; DRUG FEVER; DRUG INDICATION; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; ENTEROCOCCAL INFECTION; ESCHERICHIA COLI INFECTION; FEMALE; GENERAL CONDITION DETERIORATION; GERMANY; HEART DISEASE; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY DISEASE; MAINTENANCE DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS INFECTION; MONOTHERAPY; MORTALITY; NAUSEA; PNEUMONIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSEUDOMONAS INFECTION; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SKIN DISEASE; SKIN INFECTION; SOFT TISSUE INFECTION; STAPHYLOCOCCUS INFECTION; THORAX DISEASE; THROMBOCYTOPENIA; TOXIC SHOCK SYNDROME; TREATMENT DURATION; URINARY TRACT DISEASE;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-BACTERIAL AGENTS; APACHE; DRUG THERAPY, COMBINATION; ENTEROCOCCUS; ESCHERICHIA COLI; FEMALE; GERMANY; HUMANS; INTENSIVE CARE UNITS; INTRAABDOMINAL INFECTIONS; LOGISTIC MODELS; MALE; METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS; MIDDLE AGED; MINOCYCLINE; MULTIPLE ORGAN FAILURE; PROSPECTIVE STUDIES; SEPSIS; SEVERITY OF ILLNESS INDEX; SKIN DISEASES, BACTERIAL; STAPHYLOCOCCUS AUREUS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84867222489     PISSN: 00093157     EISSN: 14219794     Source Type: Journal    
DOI: 10.1159/000342451     Document Type: Article

References (53)

1. Talbot GH: The antibiotic development pipeline for multidrug-resistant gram-negative bacilli: current and future landscapes. Infect Control Hosp Epidemiol 2010; 31(suppl 1): S55-S58.
2. Micek ST: Alternatives to vancomycin for the treatment of methicillin-resistant Staphylococcus aureus infections. Clin Infect Dis 2007; 45(suppl 3):S184-S190.
3. Nicolau DP: Management of complicated infections in the era of antimicrobial resistance: the role of tigecycline. Expert Opin Pharmacother 2009; 10: 1213-1222.
4. Seifert H, Dowzicky MJ: A longitudinal analysis of antimicrobial susceptibility in clinical institutions in Germany as part of the Tigecycline Evaluation and Surveillance Trial (2004-2007). Chemotherapy 2009; 55: 241-252.
5. Farina C, Russello G, Chinello P, et al: In vitro activity effects of twelve antibiotics alone and in association against twenty-seven Enterococcus faecalis strains isolated from Italian patients with infective endocarditis: high in vitro synergistic effect of the association ceftriaxone-fosfomycin. Chemotherapy 2011; 57: 426-433.
6. Özbek M, Sentürk A: Postantibiotic effects of tigecycline, colistin sulfate, and levofloxacin alone or tigecycline-colistin sulfate and tigecycline-levofloxacin combinations against Acinetobacter baumanii . Chemotherapy 2010; 56: 466-471.
7. Kresken M, Leitner E, Becker K, Seifert H, et al: Susceptibility of clinical isolates of frequently encountered bacterial species to tigecycline one year after the introduction of this new class of antibiotics: results of the second multicentre surveillance trial in Germany (G-TEST II, 2007). Eur J Clin Microbiol Infect Dis 2009; 28: 1007-1011.
8. Rodvold KA, Gotfried MH, Cwik M, et al: Serum, tissue and body fluid concentrations of tigecycline after a single 100 mg dose. J Antimicrob Chemother 2006; 58: 1221-1229.
9. Dryden MS: Skin and soft tissue infection: microbiology and epidemiology. Int J Antimicrob Agents 2009; 34(suppl 1):S2-S7.
10. Kumar A, Roberts D, Wood KE, et al: Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med 2006; 34: 1589-1596.
11. Hirsch EB, Tam VH: Detection and treatment options for Klebsiella pneumoniae carbapenemases (KPCs): an emerging cause of multidrug-resistant infection. J Antimicrob Chemother 2010; 65: 1119-1125.
12. Eckmann C, Dryden M, Montravers P, et al: Antimicrobial treatment of 'complicated' intra-abdominal infections and the new IDSA guidelines? A commentary and an alternative European approach according to clinical definitions. Eur J Med Res 2011; 16: 115-126.
13. Reygaert WC: Antibiotic optimization in the difficult-to-treat patient with complicated intra-abdominal or complicated skin and skin structure infections: focus on tigecycline. Ther Clin Risk Manag 2010; 6: 419-430.
14. Grundmann H, Livermore DM, et al: Carbapenem-non-susceptible Enterobacteriaceae in Europe: conclusions from a meeting of national experts. Euro Surveill 2010; 15: 19711.
15. Livermore DM, Warner M, Mushtaq S, et al: What remains against carbapenem-resistant Enterobacteriaceae? Evaluation of chloramphenicol, ciprofloxacin, colistin, fosfomycin, minocycline, nitrofurantoin, temocillin and tigecycline. Int J Antimicrob Agents 2011; 37: 415-419.
16. Deresinsky S: Tigecycline and hospital-acquired pneumonia. Clin Infect Dis 2011; 52:iii-iv.
17. 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-S367.
18. Ellis-Grosse EJ, Babinchak T, Dartois N, et al: 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-S353.
19. 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: 329-338.
20. Yahav D, Lador A, Paul M, Leibovici L: Efficacy and safety of tigecycline: a systematic review and meta-analysis. J Antimicrob Chemother 2011; 66: 1963-1971.
21. Prasad P, Sun J, Danner RL, Natanson C: Excess deaths associated with tigecycline after approval based on noninferiority trials. Clin Infect Dis 2012; 54: 1699-1709.
22. Cai Y, Wang R, Liang, et al: Systematic review and meta-analysis of the effectiveness and safety of tigecycline for treatment of infectious disease. Antimicrob Agents Chemother 2001; 55: 1162-1172.
23. Tasina E, Haidich AB, Kokkali S, Arvanitidou M: Efficacy and safety of tigecycline for the treatment of infectious diseases: a metaanalysis. Lancet Infect Dis 2011; 11: 834-844.
24. Vardakas KZ, Rafailidis PI, Falagas ME: Effectiveness and safety of tigecycline: focus on use for approved indications. Clin Infect Dis 2012; 54: 1672.
25. Swoboda S, Ober M, Hainer C, et al: Tigecycline for the treatment of patients with severe sepsis or septic shock: a drug use evaluation in a surgical intensive care unit. J Antimicrob Chemother 2008; 61: 729-733.
26. Chemaly RF, Hanmod SS, Jiang Y, et al: Tigecycline use in cancer patients with serious infections: a report on 110 cases from a single institution. Medicine (Baltimore) 2009; 88: 211-220.
27. Vasilev K, Reshedko G, Orasan R, et al: 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-i40.
28. Poulakou G, Kontopidou FV, Paramythiotou E, et al: Tigecycline in the treatment of infections from multi-drug resistant gram-negative pathogens. J Infect 2009; 58: 273-284.
29. Gordon NC, Wareham DW: A review of clinical and microbiological outcomes following treatment of infections involving multidrugresistant Acinetobacter baumannii with tigecycline. J Antimicrob Chemother 2009; 63: 775-780.
30. Kelesidis T, Karageorgopoulos DE, Kelesidis I, et al: Tigecycline for the treatment of multidrug-resistant Enterobacteriaceae: a systematic review of the evidence from microbiological and clinical studies. J Antimicrob Chemother 2008; 62: 895-904.
31. Bassetti M, Nicolini L, Repetto E, et al: Tigecycline use in serious nosocomial infections: a drug use evaluation. BMC Infect Dis 2010; 10: 287.
32. Eckmann C, Heizmann WR, Leitner E, et al: Prospective, non-interventional, multi-centre trial of tigecycline in the treatment of severely ill patients with complicated infections-new insights into clinical results and treatment practice. Chemotherapy 2011; 57: 275-284.
33. Malangoni MA, Song J, Herrington J, et al: Randomized controlled trial of moxifloxacin compared with piperacillin-tazobactam and amoxicillin-clavulanate for the treatment of complicated intra-abdominal infections. Ann Surg 2006; 244: 204-211.
34. Ellis-Grosse EJ, Babinchak T, Dartois N, et al: 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-S353.
35. Solomkin JS, Mazuski JE, Bradley JS, et al: Diagnosis and management of complicated intra-abdominal infections in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Clin Infect Dis 2010; 50: 133-164.
36. Food and Drug Administration: Guidance for Industry: Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm071185.pdf.
37. Tygacil-(tigecycline) EMA summary of product characteristics. Pfizer Inc., July 2011.
38. Linder M, Wacha H, Feldmann U, Wesch G, Streifensand RA, Gundlach E: The Mannheim Peritonitis Index. An instrument for the intraoperative prognosis of peritonitis. Chirurg 1987; 58: 84-92.
39. Farthmann EH, Schöffel U: Epidemiology and pathophysiology of intraabdominal infections. Infection 1998; 26: 329-334.
40. Wittmann DH: Operative and nonoperative therapy of intraabdominal infections. Infection 1998; 26: 335-341.
41. Koperna T, Semmler D, Marian F: Risk stratification in emergency surgical patients: is the APACHE II score a reliable marker of physiological impairment? Arch Surg 2001; 136: 55-59.
42. Sahu SK, Gupta A, Sachan PK, et al: Outcome of secondary peritonitis based on Apache II score. Internet J Surg 2008; 14: 9.
43. Curcio D, Vargas SW, Ugarte Ubiergo S, Varón F, Rojas Suarez J, Paz Chávez C, Curiale A, Latin American Tigecycline Initial Use Registry: Tigecycline treatment of critically ill patients: the LatinUser experience. Curr Clin Pharmacol 2011; 6: 18-25.
44. Kresken M, Becker K, Seifert H, et al: Resistance trends and in vitro activity of tigecycline and 17 other antimicrobial agents against Gram-positive and Gram-negative organisms, including multidrug-resistant pathogens, in Germany. Eur J Clin Microbiol Infect Dis 2011; 30: 1095-1103.
45. Garrison MW, Mutters R, Dowzicky MJ: In vitro activity of tigecycline and comparator agents against a global collection of Gramnegative and Gram-positive organisms: Tigecycline Evaluation and Surveillance Trial 2004 to 2007. Diagn Microbiol Infect Dis 2009; 65: 288-299.
46. Stevens DL, Bisno AL, Chambers HF, et al: Practice guidelines for the diagnosis and management of skin and soft tissue infections. Clin Infect Dis 2005; 41: 1373.
47. A multicenter, randomized, double-blind, comparison study of the safety and efficacy of a once-daily dose of tigecycline versus ertapenem for the treatment of foot infections in subjects with diabetes. Clinicaltrials.gov, NCT 00366249, unpubl data.
48. Rodriguez A, Mendia A, Sirvent JM, et al: Combination antibiotic therapy improves survival in patients with community-acquired pneumonia and shock. Crit Care Med 2007; 35: 1493-1498.
49. Tumbarello M, Spanu T, Sanguinetti M, et al: Bloodstream infections caused by extendedspectrum-beta-lactamase-producing Klebsiella pneumoniae: risk factors, molecular epidemiology, and clinical outcome. Antimicrob Agents Chemother 2006; 50: 498-504.
50. Aloush V, Navon-Venezia S, Seigman-Igra Y, et al: Multidrug-resistant Pseudomonas aeruginosa: risk factors and clinical impact. Antimicrob Agents Chemother 2006; 50: 43-48.
51. Marchaim D, Navon-Venezia S, Schwaber MJ, Carmeli Y: Isolation of imipenem-resistant Enterobacter species: emergence of KPC-2 carbapenemase, molecular characterization, epidemiology, and outcomes. Antimicrob Agents Chemother 2008; 52: 1413-1418.
52. Neuner EA, Yeh JY, Hall GS, et al: Treatment and outcomes in carbapenem-resistant Klebsiella pneumoniae bloodstream infection. Diagn Microbiol Infect 2011; 69: 357-362.
53. Gardiner D, Dukart G, Cooper A, Babinchak T: Safety and efficacy of intravenous tigecycline in subjects with secondary bacteremia: pooled results from 8 phase III clinical trials. Clin Infect Dis 2010; 50: 229-238.