Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
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Coccidioidomycosis is a fungal infection acquired via inhalation of airborne fungal arthrospores of Coccidioides species in regions of endemicity in the deserts of the southwestern United States and northern Mexico. In recent years, the incidence of coccidioidomycosis has increased in areas of endemicity, and previous studies have found the highest incidence of coccidioidal infection in Arizona among persons in older age groups. ⋯ Coccidioidomycosis is a serious illness in all patients, but its different manifestations in older-aged persons, compared with those in younger-aged persons, may be related to immunosuppression rather than age alone.
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Ventilator-associated pneumonia (VAP) is a leading cause of morbidity and mortality in patients hospitalized in intensive care units. Recent studies suggest that dental plaque biofilms serve as a reservoir for respiratory pathogens. The goal of this study was to determine the genetic relationship between strains of respiratory pathogens first isolated from the oral cavity and later isolated from bronchoalveolar lavage fluid from the same patient undergoing mechanical ventilation with suspected VAP. ⋯ Respiratory pathogens isolated from the lung are often genetically indistinguishable from strains of the same species isolated from the oral cavity in patients who receive mechanical ventilation who are admitted to the hospital from the community. Thus, dental plaque serves as an important reservoir for respiratory pathogens in patients who undergo mechanical ventilation.
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The UK Department of Health has published concerns that pneumonia severity scores determined at hospital admission may underestimate the severity of pneumonia in young adults. SMART-COP (systolic blood pressure, multilobar chest radiography involvement, albumin level, respiratory rate, tachycardia, confusion, oxygenation, and arterial pH) was superior to both the CURB65 (confusion, urea, respiratory rate, systolic or diastolic blood pressure, and age >or=65 years) score and the Pneumonia Severity Index in predicting the need for mechanical ventilation and/or inotropic support, but SMART-COP would still incorrectly stratify 15% of patients.
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Antibiotic development has decreased significantly, in part because of recent changes in regulatory requirements in the United States. These changes both decrease the probability of technical and regulatory success for a new antibiotic for which marketing approval is sought and motivate the pharmaceutical industry to focus its research efforts on other therapeutic areas. ⋯ The answers to important questions about the benefit of antibacterial treatment for community-acquired pneumonia and the publication of clear guidance for future clinical studies will support future investments. We discuss the underlying issues and offer some alternative strategies to enable improvements in clinical trial design for community-acquired pneumonia.
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Review
Clinical trial design for mild-to-moderate community-acquired pneumonia--an industry perspective.
The use of noninferiority clinical trials is problematic unless one can establish the benefit of the active control versus no treatment. In community-acquired pneumonia, there are no placebo-controlled clinical trials establishing the benefit of antibiotic treatment, because the observed benefit of sulfapyridine and, subsequently, penicillin was established before the advent of randomized clinical studies. ⋯ In addition, there is one contemporary clinical trial that demonstrated superiority in clinical response of levofloxacin versus a cephalosporin regimen of ceftriaxone and/or cefuroxime for treatment of mild-to-moderate community-acquired pneumonia. Using either the historical data or the superiority study of levofloxacin, one can justify a noninferiority margin of 10% for the per-protocol population and 15% for the microbiologically evaluable population for future noninferiority clinical trials for mild-to-moderate community-acquired pneumonia.