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  1. Article ; Online: Population pharmacokinetics of prophylactic cefoxitin in elective bariatric surgery patients: a prospective monocentric study.

    Novy, Emmanuel / Liu, Xin / Hernández-Mitre, María Patricia / Belveyre, Thibaut / Scala-Bertola, Julien / Roberts, Jason A / Parker, Suzanne L

    Anaesthesia, critical care & pain medicine

    2024  Volume 43, Issue 3, Page(s) 101376

    Abstract: Background: This study describes the population pharmacokinetics of cefoxitin in obese patients undergoing elective bariatric surgery and evaluates different dosing regimens for achievement of pre-defined target exposures.: Methods: Serial blood ... ...

    Abstract Background: This study describes the population pharmacokinetics of cefoxitin in obese patients undergoing elective bariatric surgery and evaluates different dosing regimens for achievement of pre-defined target exposures.
    Methods: Serial blood samples were collected during surgery with relevant clinical data. Total serum cefoxitin concentrations were measured by chromatographic assay and analysed using a population PK approach with Pmetrics®. The cefoxitin unbound fraction (fu) was estimated. Dosing simulations were performed to ascertain the probability of target attainment (PTA) to achieve cefoxitin fu above minimum inhibitory concentrations (MIC) from surgical incision to wound closure. Fractional target attainment (FTA) was calculated against MIC distributions of common pathogens.
    Results: A total of 123 obese patients (median BMI 44.3 kg/m
    Conclusion: Intermittent dosing regimens resulted in optimal FTAs against susceptible MIC distributions of S. aureus and E. coli when simulating with 50% cefoxitin protein binding. Continuous infusion of cefoxitin may improve FTA regardless of protein binding.
    Study registration: Registration on ClinicalTrials.gov, NCT03306290.
    Language English
    Publishing date 2024-03-15
    Publishing country France
    Document type Journal Article
    ISSN 2352-5568
    ISSN (online) 2352-5568
    DOI 10.1016/j.accpm.2024.101376
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  2. Article ; Online: Stability of nafamostat in intravenous infusion solutions, human whole blood and extracted plasma: implications for clinical effectiveness studies.

    Hernández-Mitre, María Patricia / Won, Hayoung / Wallis, Steven C / Parker, Suzanne L / Roberts, Jason A

    Bioanalysis

    2023  Volume 15, Issue 12, Page(s) 673–681

    Abstract: Aim: ...

    Abstract Aim:
    MeSH term(s) Humans ; Infusions, Intravenous ; Sodium Fluoride ; Anticoagulants/pharmacology ; Temperature ; Treatment Outcome
    Chemical Substances nafamostat (Y25LQ0H97D) ; Sodium Fluoride (8ZYQ1474W7) ; Anticoagulants
    Language English
    Publishing date 2023-06-05
    Publishing country England
    Document type Journal Article
    ISSN 1757-6199
    ISSN (online) 1757-6199
    DOI 10.4155/bio-2023-0040
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  3. Article ; Online: A phase I, randomized, double-blind, placebo-controlled, ascending single- and multiple-dose study of the pharmacokinetics, safety, and tolerability of oral ceftibuten in healthy adult subjects.

    Hernández-Mitre, María Patricia / Wallis, Steven C / Morgan, Elizabeth E / Dudley, Michael N / Loutit, Jeffery S / Griffith, David C / Roberts, Jason A

    Antimicrobial agents and chemotherapy

    2023  Volume 68, Issue 1, Page(s) e0109923

    Abstract: This was a phase I, randomized, double-blind, placebo-controlled, ascending single- and multiple-dose study of oral ceftibuten to describe the pharmacokinetics (PK) ... ...

    Abstract This was a phase I, randomized, double-blind, placebo-controlled, ascending single- and multiple-dose study of oral ceftibuten to describe the pharmacokinetics (PK) of
    MeSH term(s) Adult ; Humans ; Ceftibuten ; Area Under Curve ; Double-Blind Method ; Healthy Volunteers ; Administration, Oral ; Dose-Response Relationship, Drug
    Chemical Substances Ceftibuten (IW71N46B4Y)
    Language English
    Publishing date 2023-12-07
    Publishing country United States
    Document type Randomized Controlled Trial ; Clinical Trial, Phase I ; Journal Article
    ZDB-ID 217602-6
    ISSN 1098-6596 ; 0066-4804
    ISSN (online) 1098-6596
    ISSN 0066-4804
    DOI 10.1128/aac.01099-23
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    Zs.A 809: Show issues Location:
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  4. Article ; Online: TMPRSS2 inhibitors for the treatment of COVID-19 in adults: a systematic review and meta-analysis of randomized clinical trials of nafamostat and camostat mesylate.

    Hernández-Mitre, María Patricia / Morpeth, Susan C / Venkatesh, Balasubramanian / Hills, Thomas E / Davis, Joshua / Mahar, Robert K / McPhee, Grace / Jones, Mark / Totterdell, James / Tong, Steven Y C / Roberts, Jason A

    Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases

    2024  

    Abstract: Background: Synthetic serine protease inhibitors block the cellular enzyme transmembrane protease serine 2, thus preventing SARS-CoV-2 cell entry. There are two relevant drugs in this class, namely, nafamostat (intravenous formulation) and camostat ( ... ...

    Abstract Background: Synthetic serine protease inhibitors block the cellular enzyme transmembrane protease serine 2, thus preventing SARS-CoV-2 cell entry. There are two relevant drugs in this class, namely, nafamostat (intravenous formulation) and camostat (oral formulation).
    Objective: To determine whether transmembrane protease serine 2 inhibition with nafamostat or camostat is associated with a reduced risk of 30-day all-cause mortality in adults with COVID-19.
    Data sources: Scientific databases and clinical trial registry platforms.
    Study eligibility criteria, interventions, and participants: Preprints or published randomized clinical trials (RCTs) of nafamostat or camostat vs. usual care or placebo in adults requiring treatment for COVID-19.
    Methods of data synthesis and risk-of-bias assessment: The primary outcome of the meta-analysis was 30-day all-cause mortality. Secondary outcomes included time to recovery, adverse events, and serious adverse events. Risk of bias (RoB) was assessed using the revised Cochrane RoB 2 tool for individually randomized trials. Meta-analysis was conducted in the R package meta (v7.0-0) using inverse variance and random effects. Protocol registration number was INPLASY202320120.
    Results: Twelve RCTs were included. Overall, the number of available patients was small (nafamostat = 387; camostat = 1061), the number of enrolled patients meeting the primary outcome was low (nafamostat = 12; camostat = 13), and heterogeneity was high. In hospitalized adults, we did not identify differences in 30-day all-cause mortality (risk ratio [95% CI]: 0.58 [0.19, 1.80], p 0.34; I
    Conclusion: The RCT evidence is inconclusive to determine whether there is a mortality reduction and safety with either nafamostat or camostat for the treatment of adults with COVID-19. There were high RoB, small sample size, and high heterogeneity between RCTs.
    Language English
    Publishing date 2024-02-06
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1328418-6
    ISSN 1469-0691 ; 1470-9465 ; 1198-743X
    ISSN (online) 1469-0691
    ISSN 1470-9465 ; 1198-743X
    DOI 10.1016/j.cmi.2024.01.029
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    Zs.A 4541: Show issues Location:
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  5. Article ; Online: Nafamostat Mesylate for Treatment of COVID-19 in Hospitalised Patients: A Structured, Narrative Review.

    Hernández-Mitre, María Patricia / Tong, Steven Y C / Denholm, Justin T / Dore, Gregory J / Bowen, Asha C / Lewin, Sharon R / Venkatesh, Balasubramanian / Hills, Thomas E / McQuilten, Zoe / Paterson, David L / Morpeth, Susan C / Roberts, Jason A

    Clinical pharmacokinetics

    2022  Volume 61, Issue 10, Page(s) 1331–1343

    Abstract: The search for clinically effective antivirals against the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is ongoing. Repurposing of drugs licensed for non-coronavirus disease 2019 (COVID-19) indications has been extensively investigated in ...

    Abstract The search for clinically effective antivirals against the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is ongoing. Repurposing of drugs licensed for non-coronavirus disease 2019 (COVID-19) indications has been extensively investigated in laboratory models and in clinical studies with mixed results. Nafamostat mesylate (nafamostat) is a drug licensed in Japan and Korea for indications including acute pancreatitis and disseminated intravascular coagulation. It is available only for continuous intravenous infusion. In vitro human lung cell line studies with nafamostat demonstrate high antiviral potency against SARS-CoV-2 (half maximal inhibitory concentration [IC50] of 0.0022 µM [compared to remdesivir 1.3 µM]), ostensibly via inhibition of the cellular enzyme transmembrane protease serine 2 (TMPRSS2) preventing viral entry into human cells. In addition, the established antithrombotic activity is hypothesised to be advantageous given thrombosis-associated sequelae of COVID-19. Clinical reports to date are limited, but indicate a potential benefit of nafamostat in patients with moderate to severe COVID-19. In this review, we will explore the pre-clinical, pharmacokinetic and clinical outcome data presently available for nafamostat as a treatment for COVID-19. The recruitment to ongoing clinical trials is a priority to provide more robust data on the safety and efficacy of nafamostat as a treatment for COVID-19.
    MeSH term(s) Acute Disease ; Antiviral Agents/pharmacology ; Antiviral Agents/therapeutic use ; Benzamidines ; COVID-19/drug therapy ; Fibrinolytic Agents/therapeutic use ; Guanidines ; Humans ; Pancreatitis/drug therapy ; SARS-CoV-2 ; Serine/therapeutic use
    Chemical Substances Antiviral Agents ; Benzamidines ; Fibrinolytic Agents ; Guanidines ; Serine (452VLY9402) ; nafamostat (Y25LQ0H97D)
    Language English
    Publishing date 2022-08-30
    Publishing country Switzerland
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 197627-8
    ISSN 1179-1926 ; 0312-5963
    ISSN (online) 1179-1926
    ISSN 0312-5963
    DOI 10.1007/s40262-022-01170-x
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    Zs.A 1246: Show issues Location:
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  6. Article: A protocol for an international, multicentre pharmacokinetic study for Screening Antifungal Exposure in Intensive Care Units: The SAFE-ICU study.

    Roberts, Jason A / Sime, Fekade / Lipman, Jeffrey / Hernández-Mitre, Maria Patricia / Baptista, João Pedro / Brüggemann, Roger J / Darvall, Jai / De Waele, Jan J / Dimopoulos, George / Lefrant, Jean-Yves / Mat Nor, Mohd Basri / Rello, Jordi / Seoane, Leonardo / Slavin, Monica A / Valkonen, Miia / Venditti, Mario / Wong, Wai Tat / Zeitlinger, Markus / Roger, Claire

    Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine

    2023  Volume 25, Issue 1, Page(s) 1–5

    Abstract: Objective: To describe whether contemporary dosing of antifungal drugs achieves therapeutic exposures in critically ill patients that are associated with optimal outcomes. Adequate antifungal therapy is a key determinant of survival of critically ill ... ...

    Abstract Objective: To describe whether contemporary dosing of antifungal drugs achieves therapeutic exposures in critically ill patients that are associated with optimal outcomes. Adequate antifungal therapy is a key determinant of survival of critically ill patients with fungal infections. Critical illness can alter an antifungal agents' pharmacokinetics, increasing the risk of inappropriate antifungal exposure that may lead to treatment failure and/or toxicity.
    Design setting and participants: This international, multicentre, observational pharmacokinetic study will comprise adult critically ill patients prescribed antifungal agents including fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, micafungin, anidulafungin, and amphotericin B for the treatment or prophylaxis of invasive fungal disease. A minimum of 12 patients are targeted for enrolment for each antifungal agent, across 12 countries and 30 intensive care units to perform descriptive pharmacokinetics. Pharmacokinetic sampling will occur during two dosing intervals (occasions): firstly, between days 1 and 3, and secondly, between days 4 and 7 of the antifungal course, collecting three samples per occasion. Patients' demographic and clinical data will be collected.
    Main outcome measures: The primary endpoint of the study is attainment of pharmacokinetic/pharmacodynamic target exposures that are associated with optimal efficacy. Thirty-day mortality will also be measured.
    Results and conclusions: This study will describe whether contemporary antifungal drug dosing achieves drug exposures associated with optimal outcomes. Data will also be used for the development of antifungal dosing algorithms for critically ill patients. Optimised drug dosing should be considered a priority for improving clinical outcomes for critically ill patients with fungal infections.
    Language English
    Publishing date 2023-05-20
    Publishing country Australia
    Document type Journal Article
    ZDB-ID 2401976-8
    ISSN 1441-2772
    ISSN 1441-2772
    DOI 10.1016/j.ccrj.2023.04.002
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  7. Article ; Online: Population Pharmacokinetics and Dosing Recommendations of Levetiracetam in Adult and Elderly Patients With Epilepsy.

    Hernández-Mitre, María Patricia / Medellín-Garibay, Susanna Edith / Rodríguez-Leyva, Ildefonso / Rodríguez-Pinal, Cristian Jazmín / Zarazúa, Sergio / Jung-Cook, Helgi Helene / Roberts, Jason A / Romano-Moreno, Silvia / Milán-Segovia, Rosa Del Carmen

    Journal of pharmaceutical sciences

    2020  Volume 109, Issue 6, Page(s) 2070–2078

    Abstract: The objective was to develop and externally validate a population pharmacokinetic model of levetiracetam in adult and elderly patients with epilepsy, and to perform dosing simulations to propose individualized dosing regimens more likely to achieve ... ...

    Abstract The objective was to develop and externally validate a population pharmacokinetic model of levetiracetam in adult and elderly patients with epilepsy, and to perform dosing simulations to propose individualized dosing regimens more likely to achieve therapeutic concentrations. This prospective study included 367 plasma samples from 107 patients receiving oral levetiracetam. Samples were analyzed by HPLC-UV. Pharmacokinetic data, as well as patient demographic, clinical characteristics, other drug therapy, and the use of innovator or generic products of levetiracetam, were collected. Population modeling was performed with NONMEM and included internal and external validations of the final model. Simulations were used to propose optimized dosing regimens. The pharmacokinetics of levetiracetam was described by a one-compartment model with first-order absorption and linear elimination. Body surface area had a significant effect on the apparent volume of distribution, as did creatinine clearance (CrCL) over the drug clearance (p < 0.01). The final model performed adequately during external validation testing. The final model showed a better predictive performance. Dosing simulations support 1000 mg 12-hourly dosing of levetiracetam for patients with CrCL ~60-75 mL/min with higher dose needed for higher values (1500 mg 12-hourly for CrCL ~93-111 mL/min). Dosing regimens should be personalized to the patient's CrCL to maximize the likelihood of therapeutic concentrations.
    MeSH term(s) Adult ; Aged ; Anticonvulsants/therapeutic use ; Epilepsy/drug therapy ; Humans ; Levetiracetam ; Models, Biological ; Piracetam ; Prospective Studies
    Chemical Substances Anticonvulsants ; Levetiracetam (44YRR34555) ; Piracetam (ZH516LNZ10)
    Language English
    Publishing date 2020-02-27
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 3151-3
    ISSN 1520-6017 ; 0022-3549
    ISSN (online) 1520-6017
    ISSN 0022-3549
    DOI 10.1016/j.xphs.2020.02.018
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