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

Abstract

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 β-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.

Etiologic analysis of Chinese patients with agranulocytosis and hematopathies infected with resistant bacteria: Antibacterial effect of tigecycline

“…To solve this problem, it is needed to develop a new broad-spectrum antibacterial agent. TGC was initially approved by the US FDA in June 2005 to indicate the treatment of complex skin, soft tissue, and intra-abdominal infections [13,14]. A clinical retrospective study on the efficiency and safety of the TGC treatment as empirical antibiotic therapy was performed in study.…”

Efficacy and Safety of Tigecycline for Patients with Hospital-Acquired Pneumonia

“…A logistic regression analysis [27] suggested that mortality at 30 days and mortality in the first 2 or 7 days was similar between tigecycline and the comparators, and it highlighted that treatment with tigecycline was not associated with mortality. Mortality rates were consistent with the type of infection and severity of illness [28]. In conventional-dose tigecycline-treated patients with HAP, especially those with VAP, baseline bacteremia was a significant predictor of mortality [29].…”

Sepsis outside intensive care unit: the other side of the coin

“…Median treatment duration was 8 days for BSI (range 4-17), 9 days for HAP (5-17), 10 days for IAI and CAP (7)(8)(9)(10)(11)(12)(13)(14)(15), 11 days for SSTI and DFI , and 12 days for MSI .…”

“…Results obtained in the total patient population have been published before [15]. Here, we present data on patients suffering from infections with documented involvement of bacteria exhibiting multidrugresistant phenotypes.…”