PMID- 23052187 OWN - NLM STAT- MEDLINE DCOM- 20130509 LR - 20201209 IS - 1421-9794 (Electronic) IS - 0009-3157 (Linking) VI - 58 IP - 4 DP - 2012 TI - 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. PG - 282-94 LID - 10.1159/000342451 [doi] AB - This large prospective non-interventional study investigated the effects of tigecycline either as single agent or in combination with other antimicrobial agents in 1,025 patients treated in clinical routine at German hospitals. Sixty-five percent of the patients had APACHE II scores > 15, indicating high overall disease severity. Complicated intra-abdominal infections (cIAI) or complicated skin and skin tissue infections (cSSTI) were the most common indications, with Staphylococcus aureus, Enterococcus faecium and Escherichia coli being the most frequently isolated pathogens. Clinical success was reported at the end of tigecycline therapy in 74.2% of the total population, in 75.4% of the cIAI and in 82.2% of the cSSTI patients. The subpopulation (28.0% of the patients) infected with multidrug-resistant pathogens (methicillin-resistant S. aureus, extended-spectrum beta-lactamase producers and vancomycin-resistant enterococci) were treated with similar success rates as the overall population. Tigecycline was generally well tolerated. Drug-related adverse events (AEs) were reported in 7.7% of the total population; 2.5% had serious AEs mostly attributable to inefficacy of therapy or deterioration of the disease. Mortality rates were consistent with the types of infection and severity of illness. There was no indication of excessive mortality associated with tigecycline as had been suggested in previously performed meta-analyses. In this large non-interventional study performed in the clinical routine setting, tigecycline achieved favorable clinical success rates in a patient population with high severity of illness and a high prevalence of multidrug-resistant pathogens and showed a good safety and tolerability profile. CI - Copyright (c) 2012 S. Karger AG, Basel. FAU - Bodmann, Klaus-Friedrich AU - Bodmann KF AD - Klinik fur Internistische Intensivmedizin und Interdisziplinare Notfallaufnahme, Werner Forssmann Hospital, Klinikum Barnim GmbH, Eberswalde, Germany. FAU - Heizmann, Wolfgang R AU - Heizmann WR FAU - von Eiff, Christof AU - von Eiff C FAU - Petrik, Christian AU - Petrik C FAU - Loschmann, Peter-Andreas AU - Loschmann PA FAU - Eckmann, Christian AU - Eckmann C LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20121004 PL - Switzerland TA - Chemotherapy JT - Chemotherapy JID - 0144731 RN - 0 (Anti-Bacterial Agents) RN - 70JE2N95KR (Tigecycline) RN - FYY3R43WGO (Minocycline) SB - IM MH - APACHE MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Anti-Bacterial Agents/adverse effects/*therapeutic use MH - Drug Therapy, Combination MH - Enterococcus/isolation & purification MH - Escherichia coli/isolation & purification MH - Female MH - Germany MH - Humans MH - Intensive Care Units MH - Intraabdominal Infections/complications/*drug therapy/microbiology MH - Logistic Models MH - Male MH - Methicillin-Resistant Staphylococcus aureus/isolation & purification MH - Middle Aged MH - Minocycline/adverse effects/*analogs & derivatives/therapeutic use MH - Multiple Organ Failure/etiology MH - Prospective Studies MH - Sepsis/etiology MH - Severity of Illness Index MH - Skin Diseases, Bacterial/complications/*drug therapy/microbiology MH - Staphylococcus aureus/isolation & purification MH - Tigecycline MH - Treatment Outcome MH - Young Adult EDAT- 2012/10/12 06:00 MHDA- 2013/05/10 06:00 CRDT- 2012/10/12 06:00 PHST- 2012/01/17 00:00 [received] PHST- 2012/08/07 00:00 [accepted] PHST- 2012/10/12 06:00 [entrez] PHST- 2012/10/12 06:00 [pubmed] PHST- 2013/05/10 06:00 [medline] AID - 000342451 [pii] AID - 10.1159/000342451 [doi] PST - ppublish SO - Chemotherapy. 2012;58(4):282-94. doi: 10.1159/000342451. Epub 2012 Oct 4.