Clinical Infectious Diseases | Year: 2010
Hospital-acquired pneumonia and ventilator-associated pneumonia are associated with high rates of morbidity and mortality and are often caused by drug-resistant pathogens. Trials of potential new agents to treat these serious infections are complicated by various factors associated with their design and conduct and the complex underlying conditions of the patients that can potentially obscure determination of treatment benefits. Balancing scientific rigor and optimal patient management while maintaining logistical and financial feasibility is a challenge in the conduct of these studies. Regulatory guidance could help to standardize the design and conduct of trials evaluating potentially efficacious agents. In this article, some of the important challenges that were faced in conducting trials of agents to treat hospital-acquired pneumonia and ventilator-associated pneumonia are described, and areas for which regulatory guidance would be most useful are discussed. © 2010 by the Infectious Diseases Society of America. All rights reserved.
Expert Opinion on Pharmacotherapy | Year: 2015
The concern over antibiotic resistance has been voiced since the discovery of modern antibiotics > 75 years ago. The concerns have only increased with time, with efforts to control resistance caused by widespread overuse of antibiotics in human medicine and far more than appreciated use in the feeding of animals for human consumption to promote growth. The problem is worldwide, but certain regions and selected health care institutions report far more resistance, including strains of Gram-negative bacteria that are susceptible only to the once discarded drugs polymyxin B or colistin, and pan-resistant strains are on the rise. One of the central efforts to control resistance, apart from antimicrobial stewardship, is the development of new antimicrobial agents. This has lagged significantly over the past 10 - 15 years, for a variety of reasons; but promising new agents are being developed, unfortunately none thus far addressing all potentially resistant strains. There is the unlikely, but not unreal, possibility that we could return to a pre-antibiotic era, where morbidity and mortality rates have risen dramatically and routine surgical procedures are not performed for fear of post-operative infections. The onus of control of resistance is a moral imperative that falls on the shoulders of all. © 2015 Informa UK, Ltd.
Future Microbiology | Year: 2014
Hospital-acquired bacterial pneumonia (HABP) is the second most common nosocomial infection in the USA and the leading cause of mortality among hospital-acquired infections. An increasing proportion of HABP cases are the result of infection with methicillin-resistant Staphylococcus aureus (MRSA). Telavancin is a once-daily injectable, semisynthetic lipoglycopeptide antimicrobial with bactericidal activity against susceptible Gram-positive pathogens, including MRSA. The two methodologically identical Phase III ATTAIN studies demonstrated that telavancin was noninferior to vancomycin for the treatment of HABP, including ventilator-associated bacterial pneumonia, due to S. aureus (including methicillin-sensitive S. aureus and MRSA). Telavancin showed a similar safety profile to vancomycin, except that in patients with moderate-to-severe renal impairment, there was increased mortality, which warrants caution when using telavancin in this population. Now approved in the USA for the treatment of HABP, including ventilator-associated bacterial pneumonia, caused by susceptible isolates of S. aureus when other alternatives are not suitable, telavancin offers another therapeutic option. © 2014 Future Medicine Ltd.
Theravance | Date: 2015-08-03
Theravance | Date: 2015-10-15
The invention provides compounds of formula (I): wherein the variables are defined in the specification, or a pharmaceutically-acceptable salt thereof, that are inhibitors of replication of the hepatitis C virus. The invention also provides pharmaceutical compositions comprising such compounds, methods of using such compounds to treat hepatitis C viral infections, and processes and intermediates useful for preparing such compounds.