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128. Kongress der Deutschen Gesellschaft für Chirurgie

Deutsche Gesellschaft für Chirurgie

03.05. - 06.05.2011, München

Prospective observational multi-centre trial of tigecycline in the treatment of severely ill patients with complicated infections

Meeting Abstract

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  • Christian Eckmann - Klinikum Peine, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Peine
  • Wolfgang Heizmann - Zentrum für Mikrobiologie und Infektiologie, Mikrobiologie und Infektiologie, Berlin
  • Klaus-Friedrich Bodmann - Klinikum Barnim GmbH, Eberswalde

Deutsche Gesellschaft für Chirurgie. 128. Kongress der Deutschen Gesellschaft für Chirurgie. München, 03.-06.05.2011. Düsseldorf: German Medical Science GMS Publishing House; 2011. Doc11dgch683

DOI: 10.3205/11dgch683, URN: urn:nbn:de:0183-11dgch6830

Published: May 20, 2011

© 2011 Eckmann et al.
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Outline

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Introduction: Only few data are available on the efficacy and safety of novel antibiotic agents in critically ill surgical patients. The aim of this prospective observational study was to document the efficacy and safety of tigecycline in the treatment of hospitalized, severely ill surgical patients with complicated infections. Clinical data from this collective of patients, who might profit from the use of a new broad spectrum antibiotic and in whom treatment failures are associated with a substantial morbidity and mortality, are urgently needed.

Materials and methods: Patients with complicated intraabdominal infections (cIAI) and/or complicated skin and soft-tissue infections (cSSTI) were enrolled in a prospective multi-centre NIS. Patients were to receive an initial intravenous dose of 100 mg of tigecycline, followed by 50 mg twice daily. Parameters prospectively documented included histodiagnosis and clinical findings, APACHE II score, microbiological and standard laboratory assessments, surgical measures and clinical outcomes including adverse events.

Results: Data for 656 patients (mean age 64.5±13.6 years; mean APACHE II score 19.1±9.2) were evaluated with 613 patients (93%) having at least one co-morbidity. Diagnoses were cIAI (41%), cSSTI (16%), multiple infection sites (13%) and/or other severe infections (OSI, 31%). Treatment was started because previous antibiotic treatment had failed (55%) or resistant pathogens were suspected or proven (45%). Tigecycline was administered alone in 51% and as combination therapy in 49% of patients. Rates of clinical cure or improvement with tigecycline treatment were 75%, 82%, 76%, 67% for patients with cIAI, cSSTI, OSI, and multiple infection sites, respectively. 44 patients (6.7%) had drug related adverse events, with vomiting (0.8%) and nausea (0.6%) observed most frequently. 125 patients (19%) died.

Conclusion: This study demonstrated the efficacy and safety of tigecycline in a population of severely ill patients with complicated surgical infections. Prospective observational trials allow moreover to assess the treatment behaviour of responsible clinicians.