Recommended design features of future clinical trials of antibacterial agents for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
نویسندگان
چکیده
Brad Spellberg and George Talbot, for the Infectious Diseases Society of America, American College of Chest Physicians, American Thoracic Society, and Society of Critical Care Medicine Division of General Internal Medicine, Los Angeles Biomedical Research Institute at Harbor–University of California Los Angeles (UCLA) Medical Center, and David Geffen School of Medicine at UCLA, Los Angeles, and Talbot Advisors, Wayne, Pennsylvania
منابع مشابه
Considerations in the design of clinical trials of antibacterial agents for ventilator-associated pneumonia
Ventilator-associated pneumonia (VAP) remains a cause of additional morbidity, mortality and increased healthcare costs in mechanically ventilated patients. The pathogens responsible for VAP are becoming increasingly resistant to currently available antibiotics and new antibacterial agents are required to maintain an effective therapeutic armamentarium. Clinical trials are necessary to evaluate...
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Since 1989, 12 registration trials have been submitted to the US Food and Drug Administration to support the clinical efficacy of 8 antibacterial drugs for the treatment of nosocomial pneumonia. Six trials used noninferiority designs, whereas the others were equivalence trials or lacked a prespecified hypothesis. Patients with nosocomial pneumonia and ventilator-associated pneumonia were freque...
متن کاملPosition paper: recommended design features of future clinical trials of antibacterial agents for community-acquired pneumonia.
The efficacy of new antibiotics for the treatment of community-acquired pneumonia (CAP) typically has been compared with that of established antibiotics in noninferiority clinical trials. However, the US Food and Drug Administration (FDA) is reevaluating the appropriateness of a noninferiority trial design for CAP. The resulting regulatory uncertainty about appropriate trial design has contribu...
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Background: Mycoplasma pneumoniae is one of the causes of upper and lower respiratory tract infections especially in children, and antibiotics affecting the cell wall do not affect this type of infection. This study aimed to evaluate the prevalence of Mycoplasma pneumoniae and macrolide resistance in children with community-acquired pneumonia in Kerman city. Methods: This cross-sectional study...
متن کاملThe Oropharyngeal Bacterial Colonization of Patients with Endotracheal Tube
Abstract Background and Objective: Bacterial colonization in upper respiratory airways is one of the major risk factors for the development of the ventilator–associated pneumonia (VAP), which is the most common and serious hospital-acquired infection in intensive care unit (ICU). The aim of this study was to determine the frequency of oropharyngeal microorganisms of patients with tracheal t...
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ورودعنوان ژورنال:
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
دوره 51 Suppl 1 شماره
صفحات -
تاریخ انتشار 2010