Browsing by Author "Farley, John"

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Open Access
Pediatric Antibacterial and Antifungal Trials From 2007 to 2017.
(Pediatrics, 2018-09) Thaden, Joshua T; Chiswell, Karen; Jaffe, Ian; Bergin, Stephen P; Yang, William E; Romaine, Andrew; Roberts, Jamie; Nambiar, Sumathi; Farley, John; Benjamin, Daniel K; Smith, P Brian; Tsalik, Ephraim L
BACKGROUND AND OBJECTIVES:The impact of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) on pediatric antibacterial or antifungal drug trials is unknown. Our objective was to identify and characterize trials conducted under the BPCA and/or the PREA. METHODS:Pediatric antibacterial and antifungal drug trials with industry or US federal funding registered in clinicaltrials.gov from 2007 to 2017 were identified. Those conducted under BPCA and/or PREA were identified through US Food and Drug Administration and National Institute of Child Health and Human Development databases. RESULTS:Of 17 495 pediatric trials registered on clinicaltrials.gov between October 2007 and September 2017, 122 systemic antibacterial or antifungal drug trials with industry or US federal funding were identified. Of these 122 trials, 98 (80%) involved antibacterials only, 23 (19%) antifungals only, and 1 (1%) both antibacterials and antifungals. These represented <1% (122 of 17 495) of pediatric trials. Neither pediatric antibacterial nor antifungal drug trials commonly enrolled neonates 0 to 30 days old (30% [30 of 99] vs 42% [10 of 24], respectively). Pediatric antibacterial and antifungal trials were commonly industry funded (79% [78 of 99] and 83% [20 of 24], respectively). In total, 65% (79 of 122) of pediatric antibacterial and/or antifungal drug trials were conducted under BPCA and/or PREA. Researchers in trials conducted under BPCA and/or PREA, relative to non-BPCA and/or PREA trials, more often collected pharmacokinetic data (70% [55 of 79] vs 26% [11 of 43]). CONCLUSIONS:Although the majority of pediatric antibacterial and/or antifungal drug trials were conducted under BPCA and/or PREA, the overall number was low. Greater effort is needed to stimulate such trials.
Open Access
Prophetic EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit–A Comparison of European and United States Cohorts
Bergin, Stephen P; Calvert, Sara B; Farley, John; Sun, Jie-Lena; Chiswell, Karen; Dieperink, Willem; Kluytmans, Jan; Lopez-Delgado, Juan Carlos; Leon-Lopez, Rafael; Zervos, Marcus J; Kollef, Marin H; Sims, Matthew; Kabchi, Badih A; Rubin, Daniel; Santiago, Jonas; Natarajan, Mukil; Tenaerts, Pamela; Fowler, Vance G; Holland, Thomas L; Bonten, Marc J; Hullegie, Sebastiaan J
Open Access
PROPHETIC: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit.
(Chest, 2020-06-29) Bergin, Stephen P; Coles, Adrian; Calvert, Sara B; Farley, John; Powers, John H; Zervos, Marcus J; Sims, Matthew; Kollef, Marin H; Durkin, Michael J; Kabchi, Badih A; Donnelly, Helen K; Bardossy, Ana Cecilia; Greenshields, Claire; Rubin, Daniel; Sun, Jie-Lena; Chiswell, Karen; Santiago, Jonas; Gu, Peidi; Tenaerts, Pamela; Fowler, Vance G; Holland, Thomas L
BACKGROUND:Pneumonia is the leading infection-related cause of death. Using simple clinical criteria and contemporary epidemiology to identify patients at high risk of nosocomial pneumonia should enhance prevention efforts and facilitate development of new treatments in clinical trials. RESEARCH QUESTION:What are the clinical criteria and contemporary epidemiology trends helpful in identifying patients at high risk of nosocomial pneumonia? STUDY DESIGN AND METHODS:Within the intensive care units of 28 United States hospitals, we conducted a prospective cohort study among adults hospitalized more than 48 hours and considered high risk for pneumonia (defined as treatment with invasive or noninvasive ventilatory support or high levels of supplemental oxygen). We estimated the proportion of high-risk patients developing nosocomial pneumonia. Using multivariable logistic regression, we identified patient characteristics and treatment exposures associated with increased risk of pneumonia development during the intensive care unit admission. RESULTS:Between February 6, 2016 and October 7, 2016, 4613 high-risk patients were enrolled. Among 1464/4613 (32%) high-risk patients treated for possible nosocomial pneumonia, 537/1464 (37%) met the study pneumonia definition. Among high-risk patients, a multivariable logistic model was developed to identify key patient characteristics and treatment exposures associated with increased risk of nosocomial pneumonia development (c-statistic 0.709, 95% confidence interval 0.686 to 0.731). Key factors associated with increased odds of nosocomial pneumonia included an admission diagnosis of trauma or cerebrovascular accident, receipt of enteral nutrition, documented aspiration risk, and receipt of systemic antibacterials within the preceding 90 days. INTERPRETATION:Treatment for nosocomial pneumonia is common among intensive care unit patients receiving high levels of respiratory support, yet more than half of patients treated do not fulfill standard diagnostic criteria for pneumonia. Application of simple clinical criteria may improve the feasibility of clinical trials of pneumonia prevention and treatment by facilitating prospective identification of patients at highest risk.