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  1. Article ; Online: Recombinant human plasma gelsolin (rhu-pGSN) in a patient hospitalized with critical COVID-19 pneumonia.

    Catteeuw, Julie V / DiNubile, Mark J

    Clinical infection in practice

    2021  Volume 12, Page(s) 100088

    Abstract: Life-threatening COVID-19 pneumonia follows an exaggerated immune response to SARS-CoV-2. pGSN levels fall after SARS-CoV-2 infection. Rhu-pGSN improves outcomes in models of inflammation. In an intubated patient with critical COVID-19 pneumonia and ... ...

    Abstract Life-threatening COVID-19 pneumonia follows an exaggerated immune response to SARS-CoV-2. pGSN levels fall after SARS-CoV-2 infection. Rhu-pGSN improves outcomes in models of inflammation. In an intubated patient with critical COVID-19 pneumonia and progressive hypoxemia despite standard care, improvement became evident during rhu-pGSN infusions with full recovery within a few weeks.
    Language English
    Publishing date 2021-08-10
    Publishing country England
    Document type Case Reports
    ISSN 2590-1702
    ISSN (online) 2590-1702
    DOI 10.1016/j.clinpr.2021.100088
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  2. Article: Noninferior Antibiotics: When Is "Not Bad" "Good Enough"?

    DiNubile, Mark J

    Open forum infectious diseases

    2016  Volume 3, Issue 3, Page(s) ofw110

    Abstract: Novel treatment options are urgently needed for patients with serious multidrug-resistant infections seen increasingly in routine everyday clinical practice, both in the hospital and nursing home as well as in the clinic and office setting. Unfortunately, ...

    Abstract Novel treatment options are urgently needed for patients with serious multidrug-resistant infections seen increasingly in routine everyday clinical practice, both in the hospital and nursing home as well as in the clinic and office setting. Unfortunately, the problem is no longer confined to chronically ill, repeatedly hospitalized patients. This essay explores the role of noninferiorly studies in addressing the pressing need for new antimicrobial agents to combat the emerging "superbugs", calling attention to the nuances of interpreting their sometimes less-than-straightforward results. The overriding aim is not to find better antibiotics for routinely treatable infections but to identify safe and efficacious treatment options where none presently exist.
    Language English
    Publishing date 2016-05-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2757767-3
    ISSN 2328-8957
    ISSN 2328-8957
    DOI 10.1093/ofid/ofw110
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  3. Article ; Online: Bias and asymmetry in sequential noninferiority-superiority trial designs.

    Dinubile, Mark J

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2013  Volume 56, Issue 12, Page(s) 1841–1842

    MeSH term(s) Anti-Bacterial Agents/administration & dosage ; Bias ; Clinical Trials as Topic/methods ; Humans ; Research Design
    Chemical Substances Anti-Bacterial Agents
    Language English
    Publishing date 2013-06
    Publishing country United States
    Document type Letter
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/cit148
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  4. Article ; Online: Rigor in the design of observational noninferiority trials.

    Dinubile, Mark J

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2013  Volume 57, Issue 7, Page(s) 1056

    MeSH term(s) Ampicillin/administration & dosage ; Anti-Bacterial Agents/administration & dosage ; Ceftriaxone/administration & dosage ; Endocarditis/drug therapy ; Female ; Gentamicins/administration & dosage ; Gram-Positive Bacterial Infections/drug therapy ; Humans ; Male
    Chemical Substances Anti-Bacterial Agents ; Gentamicins ; Ceftriaxone (75J73V1629) ; Ampicillin (7C782967RD)
    Language English
    Publishing date 2013-10
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/cit386
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  5. Article ; Online: Prednisolone or Pentoxifylline for Alcoholic Hepatitis.

    DiNubile, Mark J

    The New England journal of medicine

    2015  Volume 373, Issue 3, Page(s) 281–282

    MeSH term(s) Female ; Glucocorticoids/therapeutic use ; Hepatitis, Alcoholic/drug therapy ; Humans ; Male ; Pentoxifylline/therapeutic use ; Prednisolone/therapeutic use
    Chemical Substances Glucocorticoids ; Prednisolone (9PHQ9Y1OLM) ; Pentoxifylline (SD6QCT3TSU)
    Language English
    Publishing date 2015-07-16
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc1506342#SA2
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  6. Article: Adjunctive Recombinant Human Plasma Gelsolin for Severe Coronavirus Disease 2019 Pneumonia.

    DiNubile, Mark J / Parra, Sandra / Salomó, Antoni Castro / Levinson, Susan L

    Open forum infectious diseases

    2022  Volume 9, Issue 8, Page(s) ofac357

    Abstract: Background: Excessive inflammation contributes to the morbidity and mortality of severe coronavirus disease 2019 (COVID-19) pneumonia. Recombinant human plasma gelsolin (rhu-pGSN) improves disease outcomes in diverse experimental models of infectious ... ...

    Abstract Background: Excessive inflammation contributes to the morbidity and mortality of severe coronavirus disease 2019 (COVID-19) pneumonia. Recombinant human plasma gelsolin (rhu-pGSN) improves disease outcomes in diverse experimental models of infectious and noninfectious inflammation.
    Methods: In a blinded, randomized study, 61 subjects with documented COVID-19 pneumonia having a World Health Organization (WHO) Severity Score of 4 to 6 and evidence of a hyperinflammatory state were treated with standard care and either adjunctive rhu-pGSN 12 mg/kg or an equal volume of saline placebo given intravenously at entry, 12 hours, and 36 hours. The prespecified coprimary outcomes were survival without major respiratory, hemodynamic, or renal support on Day 14 and the incidence of serious adverse events (SAEs) during the 90-day study period.
    Results: All subjects receiving ≥1 dose of study drug were analyzed. Fifty-four of 61 subjects (88.5%) were WHO severity level 4 at entry. The proportions of subjects alive without support on Day 14 were 25 of 30 rhu-pGSN recipients (83.3%) and 27 of 31 placebo recipients (87.1%). Over the duration of the study, WHO Severity Scores improved similarly in both treatment groups. No statistically significant differences were observed between treatment groups at any time point examined. Two subjects died in each group. Numerically fewer subjects in the rhu-pGSN group had SAEs (5 subjects; 16.7%) or ≥ Grade 3 adverse events (5 subjects; 16.7%) than in the placebo group (8 subjects [25.8%] and 9 subjects [29.0%], respectively), mostly involving the lungs. Three rhu-pGSN recipients (10.0%) were intubated compared to 6 placebo recipients (19.4%).
    Conclusions: Overall, subjects in this study did well irrespective of treatment arm. When added to dexamethasone and remdesivir, no definitive benefit was demonstrated for rhu-pGSN relative to placebo. Safety signals were not identified after the administration of 3 doses of 12 mg/kg rhu-pGSN over 36 hours. The frequencies of SAEs and intubation were numerically fewer in the rhu-pGSN group compared with placebo.
    Language English
    Publishing date 2022-07-25
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2757767-3
    ISSN 2328-8957
    ISSN 2328-8957
    DOI 10.1093/ofid/ofac357
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  7. Article ; Online: Association of plasma gelsolin with frailty phenotype and mortality among octogenarian community-dwelling men: a cohort study.

    Strandberg, Timo E / Levinson, Susan L / DiNubile, Mark J / Jyväkorpi, Satu / Kivimäki, Mika

    Aging clinical and experimental research

    2022  Volume 34, Issue 5, Page(s) 1095–1101

    Abstract: Background: Biomarkers are needed for frailty, a common phenotype often associated with muscle loss in older people. Plasma gelsolin (pGSN) is a protein largely synthesized and secreted by skeletal muscle.: Aims: To investigate whether pGSN could be ... ...

    Abstract Background: Biomarkers are needed for frailty, a common phenotype often associated with muscle loss in older people. Plasma gelsolin (pGSN) is a protein largely synthesized and secreted by skeletal muscle.
    Aims: To investigate whether pGSN could be a biomarker of the frailty phenotype and predict mortality.
    Methods: A homogenous cohort of males (born 1919-1934, baseline n = 3490) has been followed since the 1960s. In 2010/11, frailty phenotypes by modified Fried criteria were assessed. pGSN was measured in a convenience subset (n = 469, mean age 83) and re-measured in survivors (n = 127) in 2017. Mortality through December 31, 2018 was retrieved from national registers. Regression models were used for analyses.
    Results: Of 469 males, 152 (32.4%) were robust, 284 (60.6%) prefrail, and 33 (7.0%) frail in 2010/11. There was a graded (p = 0.018) association between pGSN (mean 58.1 ug/mL, SD 9.3) and frailty. After multivariable adjustment, higher pGSN levels were associated with lower odds of having contemporaneous phenotypic prefrailty (OR per 1 SD 0.73, 95% CI 0.58-0.92) and frailty (OR per 1 SD 0.70, 95% CI 0.44-1.11). By 2018, 179 males (38.2%) had died, and higher baseline pGSN predicted a lower 7-year mortality rate (HR per 1 SD 0.85, 95% CI 0.72-1.00). pGSN concentrations in 2010/11 and 2017 were correlated (n = 127, r = 0.34, p < 0.001).
    Discussion: Higher baseline pGSN concentrations were associated with a persistently robust phenotype and lower mortality rate over 7 years in a cohort of octogenarian males with high socioeconomic status and may be a promising laboratory biomarker for the development of a frailty phenotype.
    MeSH term(s) Aged ; Aged, 80 and over ; Biomarkers ; Cohort Studies ; Frail Elderly ; Frailty ; Gelsolin ; Humans ; Independent Living ; Male ; Octogenarians ; Phenotype
    Chemical Substances Biomarkers ; Gelsolin
    Language English
    Publishing date 2022-02-15
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 2104785-6
    ISSN 1720-8319 ; 1594-0667
    ISSN (online) 1720-8319
    ISSN 1594-0667
    DOI 10.1007/s40520-022-02083-2
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  8. Article ; Online: Trials and tribulations of noninferiority: caveat emptor.

    DiNubile, Mark J

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2015  Volume 60, Issue 8, Page(s) 1290–1291

    MeSH term(s) Anti-Bacterial Agents/administration & dosage ; Bacteremia/drug therapy ; Bacteremia/microbiology ; Cefazolin/therapeutic use ; Female ; Glycopeptides/administration & dosage ; Humans ; Male ; Methicillin Resistance ; Skin Diseases, Bacterial/drug therapy ; Staphylococcal Infections/drug therapy ; Staphylococcal Infections/microbiology ; Vancomycin/administration & dosage ; Vancomycin/therapeutic use
    Chemical Substances Anti-Bacterial Agents ; Glycopeptides ; Vancomycin (6Q205EH1VU) ; Cefazolin (IHS69L0Y4T)
    Language English
    Publishing date 2015-04-15
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/civ022
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  9. Article ; Online: Premastication: a possible missing link?

    Dinubile, Mark J

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2010  Volume 51, Issue 2, Page(s) 252–253

    MeSH term(s) Eating ; Female ; HIV Infections/transmission ; Humans ; Infant ; Infant, Newborn ; Mastication
    Language English
    Publishing date 2010-07-15
    Publishing country United States
    Document type Letter
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1086/653681
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  10. Article ; Online: Serotype replacement after pneumococcal vaccination.

    DiNubile, Mark J

    Lancet (London, England)

    2012  Volume 379, Issue 9824, Page(s) 1388; author reply 1388–9

    MeSH term(s) Humans ; Pneumococcal Infections/prevention & control ; Pneumococcal Vaccines/immunology ; Serotyping ; Streptococcus pneumoniae/classification
    Chemical Substances Pneumococcal Vaccines
    Language English
    Publishing date 2012-04-14
    Publishing country England
    Document type Comment ; Letter
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(12)60590-X
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