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Drugs for Gram-Negative Bugs From 2010-2019: A Decade in Review.

ABSTRACT: A literature review spanning January 1, 2010, to December 31, 2019, was conducted using the PubMed and ISI Web of Science databases to determine the breadth of publication activity in the area of gram-negative bacteria antimicrobial therapy. The number of articles was used as a reflection of scholarly activity. First, PubMed was searched using the following Medical Subject Headings (MeSH): antibacterial agents, Enterobacteriaceae, Acinetobacter, and Pseudomonas. A total of 12 643 articles were identified within PubMed, and 77 862 articles were identified within ISI Web of Science that included these terms. Second, these articles were categorized by antibiotic class to identify relative contributions to the literature by drug category. Third, these studies were used to identify key trends in the treatment of gram-negative bacterial infections from the past decade. This review highlights advances made in the past 10 years in antibacterial pharmacotherapy and some of the challenges that await the next decade of practice.

SUBMITTER: Pontefract BA

PROVIDER: S-EPMC7393798 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Drugs for Gram-Negative Bugs From 2010-2019: A Decade in Review.

Pontefract Benjamin A BA Ho Hong T HT Crain Alexandria A Kharel Madan K MK Nybo S Eric SE

Open forum infectious diseases 20200703 7

A literature review spanning January 1, 2010, to December 31, 2019, was conducted using the PubMed and ISI Web of Science databases to determine the breadth of publication activity in the area of gram-negative bacteria antimicrobial therapy. The number of articles was used as a reflection of scholarly activity. First, PubMed was searched using the following Medical Subject Headings (MeSH): antibacterial agents, Enterobacteriaceae, Acinetobacter, and Pseudomonas. A total of 1 ...[more]

PMID: 32760748

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Project description:BackgroundIt is unknown to what extent cancer drugs approved in Switzerland by the Swissmedic fulfil criteria of clinical benefit according to the European Society of Medical Oncology Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS), the American Society of Clinical Oncology Value Framework version 2 (ASCO-VF) and the Swiss OLUtool v2 (OLUtool).Patients and methodsAn electronic search identified studies that led to marketing authorisations in Switzerland 2010-2019. Studies were evaluated according to ESMO-MCBS, ASCO-VF and OLUtool. Substantial benefit for ESMO-MCBS, was defined as a grade A or B for (neo)adjuvant intent and 4 or 5 for palliative intent. For ASCO-VF and OLUtool clinical benefit was defined as score ≥45 and A or B, respectively. Concordance between the frameworks was calculated with Cohen's Kappa (κ). Factors associated with clinical benefit were evaluated by logistic regression.ResultsIn the study period, 48 drugs were approved for 92 evaluable indications, based on 100 studies. Ratings for ESMO-MCBS, ASCO-VF and OLUtool could be performed for 100, 86, and 97 studies, respectively. Overall, 39 (39%), 44 (51%), 45 (46%) of the studies showed substantial clinical benefit according to ESMO-MCBS v1.1, ASCO-VF, OLUtool criteria, respectively. There was fair concordance between ESMO-MCBS and ASCO-VF in the palliative setting (κ = 0.31, P = 0.004) and moderate concordance between ESMO-MCBS and OLUtool (κ = 0.41, P<0.001). There was no significant concordance between ASCO-VF and OLUtool (κ = 0.18, P = 0.12). Factors associated with substantial clinical benefit in multivariable analysis were HRQoL benefit reported as secondary outcome for ESMO-MCBS and the ASCO-VF and blinded studies for OLUtool.ConclusionsAt the time of approval, only around half of the trials supporting marketing authorisation of recently approved cancer drugs in Switzerland meet the criteria for substantial clinical benefit when evaluated with ESMO-MCBS, ASCO-VF or OLUtool. There was at best only moderate concordance between the grading systems.

Project description:This narrative review aimed to clarify the characteristics of international government support for sepsis research, trends in published literature on sepsis, and potential contributions of government-source grants to progress in sepsis research between fiscal years 2010 and 2019. The data in this study were collected from the National Institutes of Health (NIH, https://projectreporter.nih.gov/reporter.cfm/) of the United States of America (USA), National Natural Science Foundation of China (NSFC, https://isisn.nsfc.gov.cn/egrantweb/), and Japan Society for the Promotion of Science (JSPS, https://kaken.nii.ac.jp/). All sepsis-related projects approved by the NIH, NSFC, and JSPS were retrieved by searching the project titles, abstracts, and key words for "sepsis," "septic shock," or "sepsis inflammatory response syndrome" between 2010 and 2019. Representative sepsis-related studies published between Jan 2010 and Aug 2020 by the first/corresponding authors from these countries were obtained by searching the PubMed database using Medical Subject Heading terms for "sepsis" in representative journals, including Nature, Cell, Science, The Lancet, New England Journal of medicine (New Engl J Med), The Journal of American Medical Association (JAMA), Critical Care Medicine (CCM), Intensive Care Medicine (ICM), Chest, Annals of Emergency Medicine (Ann Emerg Med), and American Thoracic Society journals (ATS). The total/annual institutional budgets, major funding mechanisms and schemes, superior institutions and individual principal investigators, and published original research articles in the field of sepsis in the USA, China, and Japan during the past decade were investigated. The national supporting schemes of the NIH, NSFC, and JSPS were similar. Support from these institutions is quite important for the development of the field of "sepsis" which was acknowledged in 57-64% of original research articles published in CCM. For the future development of precision medicine in sepsis, more government funding support is necessary.

Project description:The number of clinical trials conducted in mainland China, including investigator-initiated trials (IITs), has increased rapidly in recent years. However, there are few data on the characteristics of cancer-related IITs. We performed a comprehensive analysis of the landscape of cancer-related IITs in mainland China in the past decade. All cancer-related IITs registered on two clinical trial registries in the United States (www.clinicaltrials.gov, CT.gov) and mainland China (www.chictr.org.cn, ChiCTR) from 2010 to 2019 were identified. IITs were reviewed manually to validate classification, subcategorized by cancer type, and stratified by design characteristics to facilitate comparison across cancer types and with other specialties. A total of 8199 cancer-related IITs were identified. The number of trials registered annually increased over time, especially in the last 5 years. Although interventional studies were predominant, randomized double-blind studies accounted for only 8% of IITs. In the past decade, the trend for interventional studies conducted with different drugs increased year on year, although the increase in hormonal therapy IITs was not significant. Additionally, cancer-related IITs were unevenly geographically distributed, with half concentrated in the economically developed cities Shanghai, Beijing, and Guangdong. We also found an increase in registration before participant enrollment (64.9% for trials in conducted in 2015-2019 vs. 40.2% in 2010-2014, p < 0.001) and data monitoring committee use (44.5% vs. 40.0%, p = 0.001) and a decrease in randomization (51.5% vs. 62.7%, p < 0.001) and funding (36.4% vs. 56.3%, p < 0.001) between these periods. We also observed changes in intervention type (decrease in cytotoxic drug therapy [34.8% vs. 48.9%, p < 0.001]; increase in targeted therapy [17.8% vs. 14.2%, p = 0.004], immune checkpoint inhibitor therapy [6.6% vs. 0.0%, p < 0.001], and immune cell therapy [9.6% vs. 4.5%, p < 0.001]). Details of cancer-related IITs conducted during the past decade illustrate the merits of oncology research in mainland China. Although the increased quantity of IITs is encouraging, limitations remain regarding the quality of clinical trials, regional imbalances, and funding allocation.

Dataset Information

Drugs for Gram-Negative Bugs From 2010-2019: A Decade in Review.

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Drugs for Gram-Negative Bugs From 2010-2019: A Decade in Review.

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