Clinical Studies : High Dose Tigecycline Essay

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Tigecycline, the first member of the glycylcycline class of antimicrobial agents, was approved by the US Food and Drug Administration (FDA) for the treatment of complicated intraabdominal infections (cIAI), complicated skin and skin structure infections (cSSSI) and community acquired pneumonia (1). Given an expanded spectrum of in vitro antibacterial activity, tigecycline is also considered as one of the selected agents for difficult-to-treat infections in critically ill patients, although there are very limited published data of pharmacokinetics in this population. FDA issued a black box for the increased risk of mortality during tigecycline treatment for severe infections, especially for hospital-acquired pneumonia or ventilator-associated pneumonia (2). Further assessment of the cause of excess deaths in these trials may in part be attributed to suboptimal tigecycline dosing. Due to these findings, several clinical studies were conducted by increasing tigecycline dosing and obtained positive efficacy compared with other dose regimens (3, 4). High dose tigecycline may be a desirable treatment strategy, but the degree of increment of tigecycline for different infections cannot be generalized in a fixed high dosing. Optimization of tigecycline high-dose regimens for dissimilar infections is needed. Early results of animal models indicated that the ratio of the 24 h area under the curve to the minimum inhibitory concentrations (AUC0-24/MIC) was chosen as the

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