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13 results on '"de Velde, Femke"'

1. Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms : A White Paper From COMBACTE’s STAT-Net

Author

COMBACTE-NET Consortium, de Kraker, Marlieke E. A., Sommer, Harriet, de Velde, Femke, Gravestock, Isaac, Weiss, Emmanuel, McAleenan, Alexandra, Nikolakopoulos, Stavros, Amit, Ohad, Ashton, Teri, Beyersmann, Jan, Held, Leonhard, Lovering, Andrew M., MacGowan, Alasdair P., Mouton, Johan W., Timsit, Jean-François, Wilson, David, Wolkewitz, Martin, Bettiol, Esther, Dane, Aaron, and Harbarth, Stephan

Published
2018

2. Parametric and nonparametric population pharmacokinetic models to assess probability of target attainment of imipenem concentrations in critically ill patients

Author

de Velde, Femke, de Winter, Brenda C M, Neely, Michael N, Strojil, Jan, Yamada, Walter M, Harbarth, Stéphan Juergen, Csaki Huttner, Angela, van Gelder, Teun, Koch, Birgit C P, Muller, Anouk E, COMBACTE-NET Consortium, Medical Microbiology & Infectious Diseases, and Pharmacy

Subjects
ddc:616, Simulations, imipenem, population pharmacokinetic modeling, parametric, nonparametric, simulations, Pharmaceutical Science, Article, RS1-441, Imipenem, Population pharmacokinetic modeling, Pharmacy and materia medica, Nonparametric, Parametric
Abstract

Population pharmacokinetic modeling and simulation (M&S) are used to improve antibiotic dosing. Little is known about the differences in parametric and nonparametric M&S. Our objectives were to compare (1) the external validation of parametric and nonparametric models of imipenem in critically ill patients and (2) the probability of target attainment (PTA) calculations using simulations of both models. The M&S software used was NONMEM 7.2 (parametric) and Pmetrics 1.5.2 (nonparametric). The external predictive performance of both models was adequate for eGFRs ≥ 78 mL/min but insufficient for lower eGFRs, indicating that the models (developed using a population with eGFR ≥ 60 mL/min) could not be extrapolated to lower eGFRs. Simulations were performed for three dosing regimens and three eGFRs (90, 120, 150 mL/min). Fifty percent of the PTA results were similar for both models, while for the other 50% the nonparametric model resulted in lower MICs. This was explained by a higher estimated between-subject variability of the nonparametric model. Simulations indicated that 1000 mg q6h is suitable to reach MICs of 2 mg/L for eGFRs of 90–120 mL/min. For MICs of 4 mg/L and for higher eGFRs, dosing recommendations are missing due to largely different PTA values per model. The consequences of the different modeling approaches in clinical practice should be further investigated.

Published
2021

5. Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms: A White Paper From COMBACTE’s STAT-Net

Author

de Kraker, Marlieke E A; https://orcid.org/0000-0003-0903-8614, Sommer, Harriet, de Velde, Femke, Gravestock, Isaac, Weiss, Emmanuel, McAleenan, Alexandra, Nikolakopoulos, Stavros, Amit, Ohad, Ashton, Teri, Beyersmann, Jan, Held, Leonhard, Lovering, Andrew M, MacGowan, Alasdair P, Mouton, Johan W, Timsit, Jean-François, Wilson, David, Wolkewitz, Martin, Bettiol, Esther, Dane, Aaron, Harbarth, Stephan, de Kraker, Marlieke E A; https://orcid.org/0000-0003-0903-8614, Sommer, Harriet, de Velde, Femke, Gravestock, Isaac, Weiss, Emmanuel, McAleenan, Alexandra, Nikolakopoulos, Stavros, Amit, Ohad, Ashton, Teri, Beyersmann, Jan, Held, Leonhard, Lovering, Andrew M, MacGowan, Alasdair P, Mouton, Johan W, Timsit, Jean-François, Wilson, David, Wolkewitz, Martin, Bettiol, Esther, Dane, Aaron, and Harbarth, Stephan

Abstract

Innovations are urgently required for clinical development of antibacterials against multidrug-resistant organisms. Therefore, a European, public-private working group (STAT-Net; part of Combatting Bacterial Resistance in Europe [COMBACTE]), has reviewed and tested several innovative trials designs and analytical methods for randomized clinical trials, which has resulted in 8 recommendations. The first 3 focus on pharmacokinetic and pharmacodynamic modeling, emphasizing the pertinence of population-based pharmacokinetic models, regulatory procedures for the reassessment of old antibiotics, and rigorous quality improvement. Recommendations 4 and 5 address the need for more sensitive primary end points through the use of rank-based or time-dependent composite end points. Recommendation 6 relates to the applicability of hierarchical nested-trial designs, and the last 2 recommendations propose the incorporation of historical or concomitant trial data through Bayesian methods and/or platform trials. Although not all of these recommendations are directly applicable, they provide a solid, evidence-based approach to develop new, and established, antibacterials and address this public health challenge.

Published
2018

7. Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms: A White Paper From COMBACTE's STAT-Net

Author

Kraker, MEA, Sommer, H, de Velde, Femke, Gravestock, I, Weiss, E, McAleenan, A, Nikolakopoulos, S, Amit, O, Ashton, T, Beyersmann, J, Held, L, Lovering, AM, MacGowan, AP, Mouton, Johan, Timsit, JF, Wilson, D, Wolkewitz, M, Bettiol, E, Dane, A, Harbarth, S, Kraker, MEA, Sommer, H, de Velde, Femke, Gravestock, I, Weiss, E, McAleenan, A, Nikolakopoulos, S, Amit, O, Ashton, T, Beyersmann, J, Held, L, Lovering, AM, MacGowan, AP, Mouton, Johan, Timsit, JF, Wilson, D, Wolkewitz, M, Bettiol, E, Dane, A, and Harbarth, S

Published
2018

11. Highly variable absorption of clavulanic acid during the day: a population pharmacokinetic analysis.

Author

Mouton, Johan W., De Velde, Femke, De Winter, Brenda C. M., Van Gelder, Teun, Koch, Birgit C. P., and COMBACTE-NET consortium

Subjects
*CLAVULANIC acid, *ABSORPTION (Physiology), *PHARMACOKINETICS, *AMOXICILLIN, *MONTE Carlo method, *ANTIBIOTICS, *BIOAVAILABILITY, *BLOOD testing, *COMPARATIVE studies, *CROSSOVER trials, *ENZYME inhibitors, *RESEARCH methodology, *MEDICAL cooperation, *RESEARCH, *SYSTEM analysis, *EVALUATION research, *HUMAN research subjects
Abstract

Objectives: To calculate the clavulanic acid exposure of oral amoxicillin/clavulanic acid dosing regimens, to investigate variability using a population pharmacokinetic model and to explore target attainment using Monte Carlo simulations.Methods: Two groups of healthy male volunteers received amoxicillin/clavulanic acid tablets at the start of a standard meal on two separate days 1 week apart. One group (n = 14) received 875/125 mg q12h and 500/125 mg q8h and the other group (n = 15) received 500/125 mg q12h and 250/125 mg q8h. In total, 1479 blood samples were collected until 8-12 h after administration. Concentrations were analysed using non-compartmental (WinNonLin) and population pharmacokinetic (NONMEM) methods.Results: Median Cmax and AUC0-8 were 2.21 mg/L (0.21-4.35) and 4.99 mg·h/L (0.44-8.31), respectively. In 40/58 daily concentration-time profiles, Cmax and AUC0-8 of the morning dose were higher than with later doses. The final population model included a lag time (0.447 h), first-order absorption (3.99 h-1 at 8:00 h, between-subject variability 52.8%, between-occasion variability 48.5%), one distribution compartment (33.0 L, between-subject variability 23.9%) and first-order elimination (24.6 L/h, between-subject variability 26.7%). Bioavailability (fixed at 1 at 8:00 h, between-occasion variability 28.2%) and absorption rate decreased over the day. For 97.5% of the simulated population after 125 mg q12h or q8h, %fT > Ct at 0.5 mg/L was 8.33% (q12h) and 15.2% (q8h), %fT > Ct at 1 mg/L was 0% (q12h + q8h), and fAUC0-24 was 3.61 (q12h) and 5.56 (q8h)  mg·h/L.Conclusions: Clavulanic acid absorption in healthy volunteers is highly variable. Bioavailability and absorption rate decrease over the day. The model developed here may serve to suggest clavulanic acid dosing regimens to optimize efficacy and prevent underdosing. [ABSTRACT FROM AUTHOR]

Published
2018
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12. Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms: A White Paper From COMBACTE’s STAT-Net

Author

de Kraker, Marlieke E A, Sommer, Harriet, de Velde, Femke, Gravestock, Isaac, Weiss, Emmanuel, McAleenan, Alexandra, Nikolakopoulos, Stavros, Amit, Ohad, Ashton, Teri, Beyersmann, Jan, Held, Leonhard, Lovering, Andrew M, MacGowan, Alasdair P, Mouton, Johan W, Timsit, Jean-François, Wilson, David, Wolkewitz, Martin, Bettiol, Esther, Dane, Aaron, and Harbarth, Stephan

Subjects
3. Good health

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