Efficacy of tigecycline for the treatment of complicated intraabdominal infections in real-life clinical practice from five european observational studies

Journal of Antimicrobial Chemotherapy

Volumn 68, Issue SUPPL.2, 2013, Pages

  Eckmann, Christian ^a   Montravers, Philippe ^b   Bassetti, Matteo ^c   Bodmann, Klaus Friedrich ^d   Heizmann, Wolfgang R ^e   Garcií, Miguel Sánchez ^f   Guirao, Xavier ^g,h   Capparella, Maria Rita ⁱ   Simoneau, Damien ⁱ   Dupont, Hervé ^j  

^a Klinikum Peine   (Germany)

^b UNIVERSITÉ PARIS DESCARTES   (France)

^c SANTA MARIA DELLA MISERICORDIA UNIVERSITY HOSPITAL   (Italy)

^d Werner Forssmann Hospital   (Germany)

^e Center for Microbiology and Infectious Diseases   (Germany)

^f UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

^g HOSPITAL GENERAL DE GRANOLLERS   (Spain)

^h UNIVERSITAT INTERNACIONAL DE CATALUNYA   (Spain)

ⁱ PFIZER INC   (United States)

^j UNIVERSITÉ DE PICARDIE JULES VERNE   (France)

more..

Author keywords

Broad Spectrum Antibacterial Therapy; Generalized Peritonitis; Glycylcycline antibiotics; Non Interventional Studies

Indexed keywords

AMIKACIN; CEFEPIME; CEFTAZIDIME; CIPROFLOXACIN; GLYCOPEPTIDE; IMIPENEM; MEROPENEM; METRONIDAZOLE; PIPERACILLIN PLUS TAZOBACTAM; TIGECYCLINE;

ABDOMINAL INFECTION; ADULT; ANTIBIOTIC RESISTANCE; ANTIBIOTIC THERAPY; APACHE; ARTICLE; CLINICAL PRACTICE; COMORBIDITY; COMPLICATED INTRAABDOMINAL INFECTION; DISEASE SEVERITY; DRUG EFFICACY; DRUG WITHDRAWAL; ENTEROCOCCUS FAECALIS; ENTEROCOCCUS FAECIUM; ESCHERICHIA COLI; FEMALE; FRANCE; GERMANY; HOSPITAL INFECTION; HUMAN; INTENSIVE CARE UNIT; ITALY; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; OBSERVATIONAL STUDY; PERITONITIS; SEQUENTIAL ORGAN FAILURE ASSESSMENT SCORE; SPAIN; TREATMENT DURATION; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

BROAD-SPECTRUM ANTIBACTERIAL THERAPY; GENERALIZED PERITONITIS; GLYCYLCYCLINE ANTIBIOTICS; NON-INTERVENTIONAL STUDIES;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTI-BACTERIAL AGENTS; DRUG THERAPY, COMBINATION; EUROPE; FEMALE; GRAM-NEGATIVE BACTERIAL INFECTIONS; GRAM-POSITIVE BACTERIAL INFECTIONS; HUMANS; INTRAABDOMINAL INFECTIONS; MALE; MIDDLE AGED; MINOCYCLINE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84879398109     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dkt142     Document Type: Article

References (41)

1. Blot S, De Waele JJ. Critical issues in the clinical management of complicated intra-abdominal infections. Drugs 2005; 65: 1611-20.
2. Sturkenboom MC, Goettsch WG, Picelli G et al. Inappropriate initial treatment of secondary intra-abdominal infections leads to increased risk of clinical failure and costs. Br J Clin Pharmacol 2005; 60: 438-43.
3. Edelsberg J, Berger A, Schell S, et al. Economic consequences of failure of initial antibiotic therapy in hospitalized adults with complicated intra-abdominal infections. Surg Infect (Larchmt) 2008; 9: 335-47.
4. 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: 419-30.
5. 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. Surg Infect (Larchmt) 2010; 11: 79-109.
6. 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: 115-26.
7. Tygacil Summary of Product Characteristics. Sandwich, Kent, UK: Pfizer Ltd, 2012.
8. Dowzicky MJ, Chmelarova E. Global in vitro activity of tigecycline and linezolid against Gram-positive organisms collected between 2004 and 2009. Int J Antimicrob Agents 2011; 37: 562-6.
9. Andrasevic AT, Dowzicky MJ. In vitro activity of tigecycline and comparators against Gram-negative pathogens isolated from blood in Europe (2004-2009). Int J Antimicrob Agents 2012; 39: 115-23.
10. Mayne D, Dowzicky MJ. In vitro activity of tigecycline and comparators against organisms associated with intra-abdominal infections collected as part of TEST (2004-2009). Diagn Microbiol Infect Dis 2012; 74: 151-7.
11. Chen Z, Wu J, Zhang Y, et al. Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial. BMC Infect Dis 2010; 10: 217.
12. 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.
13. Fomin P, Koalov S, Cooper A, et al. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections -the European experience. J Chemother 2008; 20 Suppl 1: 12-9.
14. Oliva ME, Rekha A, Yellin A, et al. A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID Numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744]. BMC Infect Dis 2005; 5: 88.
15. Towfigh S, Pasternak J, Poirier A, et al. A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infections. Clin Microbiol Infect 2010; 16: 1274-81.
16. US FDA. FDA Drug Safety Communication: Increased Risk of Death With Tygacil (Tigecycline) Compared to Other Antibiotics Used to Treat Similar Infections (1 September 2010). http://www.fda.gov/drugs/drugsafety/ucm224370.htm (26 September 2012, date last accessed).
17. Cai Y, Wang R, Liang B, et al. Systematic review and meta-analysis of the effectiveness and safety of tigecycline for treatment of infectious disease. Antimicrob Agents Chemother 2011; 55: 1162-72.
18. Tasina E, Haidich AB, Kokkali S, et al. Efficacy and safety of tigecycline for the treatment of infectious diseases: a meta-analysis. Lancet Infect Dis 2011; 11: 834-44.
19. Vardakas KZ, Rafailidis PI, Falagas ME. Effectiveness and safety of tigecycline: focus on use for approved indications. Clin Infect Dis 2012; 54: 1672-4.
20. Yahav D, Lador A, Paul M, et al. Efficacy and safety of tigecycline: a systematic review and meta-analysis. J Antimicrob Chemother 2011; 66: 1963-71.
21. European Medicines Agency. EPAR Summary for the Public: Tygacil (last updated February 2012). http://www.ema.europa.eu/docs/en_ GB/document_library/EPAR_-_Summary_for_the_public/human/000644/WC500044509.pdf (6 November 2012, date last accessed).
22. 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: 729-33.
23. Bodmann KF, Heizmann WR, von Eiff C, et al. 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 2012; 58: 282-94.
24. 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: 275-84.
25. Montravers P, Dupont H, Bedos JP, et al. Use of tigecycline in intensive care: a French prospective observational study. Clin Microbiol Infect 2012; 18: 767-8.
26. Bassetti M, Nicolini L, Repetto E, et al. Tigecycline use in serious nosocomial infections: a drug use evaluation. BMC Infect Dis 2010; 10: 287.
27. Sanchez Garcia M, on behalf of the Tigecycline in Critically Ill Patients Study Group. Observational study of the use of tigecycline (TGC) in critically ill patients (CIP). In: Abstracts of the Fifty-first Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, IL, USA, 2011. Abstract K-1412. American Society for Microbiology, Washington, DC, USA.
28. Bassetti M, Eckmann C, Bodmann KF, et al. Prescription behaviours for tigecycline in real-life clinical practice from five European observational studies. J Antimicrob Chemother 2013; 68 Suppl 2: ii5-14.
29. Heizmann WR, Dupont H, Montravers P, et al. Resistance mechanisms and epidemiology of multiresistant pathogens in Europe and efficacy of tigecycline in observational studies. J Antimicrob Chemother 2013; 68 Suppl 2: ii45-55.
30. Guirao X, Sánchez Garcií M, Bassetti M, et al. Safety and tolerability of tigecycline for the treatment of complicated skin and soft-tissue and intra-abdominal infections: an analysis based on five European observational studies. J Antimicrob Chemother 2013; 68 Suppl 2: ii37-44.
31. Sartelli M, Viale P, Koike K, et al. WSES consensus conference: guidelines for first-line management of intra-abdominal infections. World J Emerg Surg 2011; 6: 2.
32. Sartelli M, Catena F, Coccolini F, et al. Antimicrobial management of intra-abdominal infections: literature's guidelines. World J Gastroenterol 2012; 18: 865-71.
33. Cubicin Summary of Product Characteristics. Frimley, Surrey, UK: Novartis Pharmaceuticals UK Ltd, 2012.
34. Zyvox Summary of Product Characteristics. Sandwich, Kent, UK: Pharmacia Limited, 2011.
35. Sandiumenge A, Diaz E, Rodriguez A, et al. Impact of diversity of antibiotic use on the development of antimicrobial resistance. J Antimicrob Chemother 2006; 57: 1197-204.
36. Takesue Y, Nakajima K, Ichiki K, et al. Impact of a hospital-wide programme of heterogeneous antibiotic use on the development of antibiotic-resistant Gram-negative bacteria. J Hosp Infect 2010; 75: 28-32.
37. Nicolau DP, Carmeli Y, Crank CW, et al. Carbapenem stewardship: does ertapenem affect Pseudomonas susceptibility to other carbapenems? A review of the evidence. Int J Antimicrob Agents 2012; 39: 11-5.
38. European Medicines Agency. Questions and Answers on the Review of Tygacil (Tigecycline): Outcome of a Renewal Procedure (17 February 2011). http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/human/000644/WC500102228.pdf (22 March 2012, date last accessed).
39. Knaus WA, Draper EA, Wagner DP, et al. APACHE II: a severity of disease classification system. Crit Care Med 1985; 13: 818-29.
40. Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA 1993; 270: 2957-63.
41. French Society of Anesthesia and Intensive Care. Scoring Systems for ICU and Surgical Patients: APACHE II (Acute Physiology and Chronic Health Evaluation). http://www.sfar.org/scores2/apache22.html (12 February 2013, date last accessed).