Expert review of anti-infective therapy
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Expert Rev Anti Infect Ther · Dec 2012
ReviewFrequency of the off-label use of antibiotics in clinical practice: a systematic review.
Antibiotics constitute a major class among drugs commonly prescribed either empirically or for microbiologically documented infections in clinical practice. In addition, due to medical necessity physicians are forced, at times, to prescribe medications for off-label indications. The authors sought to record the frequency of the off-label use of antibiotics among both adult and pediatric patients. ⋯ Antibiotics are frequently prescribed as off-label among patient populations. The wide variation observed in the off-label use of antibiotics among pediatric patients might be attributed to the heterogeneity among the study populations regarding the age of children. Although this unapproved manner of prescribing cannot always be avoided, clinicians should only use unapproved drugs in cases when there are no effective alternatives are available and based on scientific evidence regarding safety and effectiveness.
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Expert Rev Anti Infect Ther · Nov 2012
Review Historical ArticleA long and winding road; evolution of antimicrobial drug development - crisis management.
The development of antimicrobial drugs has evolved from observational case reports to complex randomized prospective clinical trials in specific treatment indications. Beginning around the year 2000, the US FDA has evolved its approach on study design and other study characteristics, which has made the conduct of these studies more difficult and the outcomes for sponsors more risky. ⋯ This study reviews the historical basis for the current regulatory climate including the various crises that have led to considerable political pressures on the agency. Recent efforts to resolve development uncertainties and to provide economic incentives for future antimicrobial drug development are presented.
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Expert Rev Anti Infect Ther · Oct 2012
Pulmonary infections and resistance to antibiotics: recent information.
This yearly international meeting, 'Infections in the Critically Ill Patient' (3-4 February 2012, Barcelona, Spain) attended by 300 people from many different countries, was the 17th edition. This meeting gathers scientists from different horizons: microbiologists, infectious diseases specialists, intensivists and researchers in the fields of the meeting: sepsis, severe infections and pneumonia. This multidisciplinarity allows a rich cross-fertilization and outstanding discussions. This document summarizes the full day devoted to pulmonary infections and resistance to antibiotics.