Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
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Data are limited on outcomes of treatment with extended-spectrum cephalosporins (ESCs) for infections caused by Enterobacteriaceae that produce extended-spectrum beta-lactamases (ESBLs). This study describes the largest treatment experience of a nonoutbreak series of bloodstream infections caused by strains of Escherichia coli (23 episodes) and Klebsiella pneumoniae (13 episodes) with a ceftazidime minimal inhibitory concentration of > or =2 microg/mL. E. coli isolates produced a greater variety of beta-lactamase types than did K. pneumoniae isolates, among which ESBL production was predominant. ⋯ Most patients were treated empirically with an ESC-based regimen. A favorable response to treatment with a nonceftazidime ESC was observed when the causative pathogen produced either TEM-6 or TEM-12; ceftazidime treatment was associated with failure of therapy in all patients. Despite the limited clinical success, ESCs are currently not recommended for the treatment of serious infections caused by ESBL-producing strains.
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I address 2 important topics of current good manufacturing practices as they apply to vaccine products: product inspections and stability testing. The perspective presented is that of regulated industry. There are 2 major categories of product/facility inspections: those occurring before licensure of a vaccine product and those occurring after a vaccine product is licensed. ⋯ The requirements, guidance, and recommendations regarding the type, amount, and extensiveness of stability data for vaccine products are presented. The discussion details the potential differences in the amount and type of data required for products that are not yet licensed versus marketed products. Guidance, from a regulated industry perspective, regarding the design and implementation of a successful stability program is also discussed.
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The evaluation and management of hepatitis C differ from those of other infectious diseases in important ways. In this review, the roles of liver biopsy, virus load determination, and genotyping in the pretreatment evaluation and monitoring of patients with hepatitis C are discussed from a hepatologist's perspective.