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4. A meta-analysis of protein binding of flucloxacillin in healthy volunteers and hospitalized patients

Author

Wallenburg, E., Brüggemann, R. J. M., Roberts, J. A., Jager, N. G. L., Ulldemolins, M., Wilkes, S., Schouten, J., Chin, P. K. L., ter Heine, R., Wallenburg, E., Brüggemann, R. J. M., Roberts, J. A., Jager, N. G. L., Ulldemolins, M., Wilkes, S., Schouten, J., Chin, P. K. L., and ter Heine, R.

Abstract

Objectives: The aim of this study was to develop a mechanistic protein-binding model to predict the unbound flucloxacillin concentrations in different patient populations. Methods: A mechanistic protein-binding model was fitted to the data using non-linear mixed-effects modelling. Data were obtained from four datasets, containing 710 paired total and unbound flucloxacillin concentrations from healthy volunteers, non-critically ill and critically ill patients. A fifth dataset with data from hospitalized patients was used for evaluation of our model. The predictive performance of the mechanistic model was evaluated and compared with the calculation of the unbound concentration with a fixed unbound fraction of 5%. Finally, we performed a fit-for-use evaluation, verifying whether the model-predicted unbound flucloxacillin concentrations would lead to clinically incorrect dose adjustments. Results: The mechanistic protein-binding model predicted the unbound flucloxacillin concentrations more accurately than assuming an unbound fraction of 5%. The mean prediction error varied between –26.2% to 27.8% for the mechanistic model and between –30.8% to 83% for calculation with a fixed factor of 5%. The normalized root mean squared error varied between 36.8% and 69% respectively between 57.1% and 134%. Predicting the unbound concentration with the use of the mechanistic model resulted in 6.1% incorrect dose adjustments versus 19.4% if calculated with a fixed unbound fraction of 5%. Conclusions: Estimating the unbound concentration with a mechanistic protein-binding model outperforms the calculation with the use of a fixed protein binding factor of 5%, but neither demonstrates acceptable performance. When performing dose individualization of flucloxacillin, this should be done based on measured unbound concentrations rather than on estimated unbound concentrations from the measured total concentrations. In the absence of an assay for unbound concentrations, the mechanistic bin

Published
2022

15. Diagnosis and management of Aspergillus diseases: executive summary of the 2017 ESCMID-ECMM-ERS guideline

Author

Ullmann, A. J., Aguado, J. M., Arikan-Akdagli, S., Denning, D. W., Groll, A. H., Lagrou, K., Lass-Flörl, C., Lewis, R. E., Munoz, P., Verweij, P. E., Warris, A., Ader, F., Akova, M., Arendrup, M. C., Barnes, R. A., Beigelman-Aubry, C., Blot, S., Bouza, E., Brüggemann, R. J. M., Buchheidt, D., Cadranel, J., Castagnola, E., Chakrabarti, A., Cuenca-Estrella, M., Dimopoulos, G., Fortun, J., Gangneux, J. -P., Garbino, J., Heinz, W. J., Herbrecht, R., Heussel, C. P., Kibbler, C. C., Klimko, N., Kullberg, B. J., Lange, C., Lehrnbecher, T., Löffler, J., Lortholary, O., Maertens, J., Marchetti, O., Meis, J. F., Pagano, Livio, Ribaud, P., Richardson, M., Roilides, E., Ruhnke, M., Sanguinetti, Maurizio, Sheppard, D. C., Sinkó, J., Skiada, A., Vehreschild, M. J. G. T., Viscoli, C., Cornely, O. A., Pagano, L. (ORCID:0000-0001-8287-928X), Sanguinetti, M. (ORCID:0000-0002-9780-7059), Ullmann, A. J., Aguado, J. M., Arikan-Akdagli, S., Denning, D. W., Groll, A. H., Lagrou, K., Lass-Flörl, C., Lewis, R. E., Munoz, P., Verweij, P. E., Warris, A., Ader, F., Akova, M., Arendrup, M. C., Barnes, R. A., Beigelman-Aubry, C., Blot, S., Bouza, E., Brüggemann, R. J. M., Buchheidt, D., Cadranel, J., Castagnola, E., Chakrabarti, A., Cuenca-Estrella, M., Dimopoulos, G., Fortun, J., Gangneux, J. -P., Garbino, J., Heinz, W. J., Herbrecht, R., Heussel, C. P., Kibbler, C. C., Klimko, N., Kullberg, B. J., Lange, C., Lehrnbecher, T., Löffler, J., Lortholary, O., Maertens, J., Marchetti, O., Meis, J. F., Pagano, Livio, Ribaud, P., Richardson, M., Roilides, E., Ruhnke, M., Sanguinetti, Maurizio, Sheppard, D. C., Sinkó, J., Skiada, A., Vehreschild, M. J. G. T., Viscoli, C., Cornely, O. A., Pagano, L. (ORCID:0000-0001-8287-928X), and Sanguinetti, M. (ORCID:0000-0002-9780-7059)

Abstract

The European Society for Clinical Microbiology and Infectious Diseases, the European Confederation of Medical Mycology and the European Respiratory Society Joint Clinical Guidelines focus on diagnosis and management of aspergillosis. Of the numerous recommendations, a few are summarized here. Chest computed tomography as well as bronchoscopy with bronchoalveolar lavage (BAL) in patients with suspicion of pulmonary invasive aspergillosis (IA) are strongly recommended. For diagnosis, direct microscopy, preferably using optical brighteners, histopathology and culture are strongly recommended. Serum and BAL galactomannan measures are recommended as markers for the diagnosis of IA. PCR should be considered in conjunction with other diagnostic tests. Pathogen identification to species complex level is strongly recommended for all clinically relevant Aspergillus isolates; antifungal susceptibility testing should be performed in patients with invasive disease in regions with resistance found in contemporary surveillance programmes. Isavuconazole and voriconazole are the preferred agents for first-line treatment of pulmonary IA, whereas liposomal amphotericin B is moderately supported. Combinations of antifungals as primary treatment options are not recommended. Therapeutic drug monitoring is strongly recommended for patients receiving posaconazole suspension or any form of voriconazole for IA treatment, and in refractory disease, where a personalized approach considering reversal of predisposing factors, switching drug class and surgical intervention is also strongly recommended. Primary prophylaxis with posaconazole is strongly recommended in patients with acute myelogenous leukaemia or myelodysplastic syndrome receiving induction chemotherapy. Secondary prophylaxis is strongly recommended in high-risk patients. We strongly recommend treatment duration based on clinical improvement, degree of immunosuppression and response on imaging.

Published
2018

16. Pharmacokinetics of Anidulafungin in critically ill patients in the Intensive Care Unit with suspected or proven invasive fungal infections

Author

Brüggemann, R J M, Middel-Baars, V, de Lange, D W, Colbers, A, Girbes, A R J, Pickkers, P, and Swart, E L

Subjects
Journal Article
Abstract

Echinocandins, such as anidulafungin are first line treatment for candidemia or invasive candidiasis in critically ill patients. There is conflicting data on the pharmacokinetic properties of anidulafungin in ICU patients. Adult ICU patients (from 3 hospitals) receiving anidulafungin for suspected or proven fungal infections were included. Patient were considered evaluable when a pharmacokinetic curve on day 3 could be completed. 23 out of 36 patients (7 female, 16 male) were evaluable. Median (range) age and bodyweight were 66 (28-88) yr and 76 (50-115) kg. Pharmacokinetic sampling on day 3 (n=23) resulted in a median anidulafungin AUC0-24h of 72.1 (IQR 61.3-94.0) mg*h*L(-1), a median C24 of 2.2 (IQR 1.9-2.9) mg/L, a median Cmax of 5.3 (IQR 4.1-6.0) mg/L, a median Vd of 46.0 (IQR 32.2-60.2) L and a median CL of 1.4 (IQR 1.1-1.6) L*h-1. Pharmacokinetic sampling on day 7 (n=13) resulted in a median AUC0-24h of 82.7 (IQR 73.0 - 129.5) mg*h*L(-1), a median Cmin of 2.8 (IQR 2.2 - 4.2) mg/L, a median Cmax of 5.9 (IQR 4.6 - 8.0) mg/L, a median Vd of 39.7 (IQR 32.2 - 54.4) L and a median CL of 1.2 (IQR 0.8 - 1.4) L*h(-1) The Geometric Mean Ratio for AUCday7/AUCday3 was 1.13 (90% CI 1.03 - 1.25). The exposure in the ICU patient population was in accordance with previous reports on anidulafungin in ICU patients but was lower compared to healthy volunteers or other patient populations. Larger cohorts of patients or pooled data analyses are necessary to retrieve relevant covariates.

Published
2017

23. Ciprofloxacin penetration into infected hepatic cysts in autosomal dominant polycystic kidney disease: a case report.

Author

Bernts, L H P, Wallenburg, E, Jonge, H J M de, Schaap, B, Kusters, R, Overtoom, T T C, Brüggemann, R J M, Drenth, J P H, Lantinga, M A, and de Jonge, H J M

Subjects
POLYCYSTIC kidney disease, POLYCYSTIC kidney disease treatment, CIPROFLOXACIN, KLEBSIELLA pneumoniae, PHARMACOKINETICS, CYSTIC kidney disease, ANTIBIOTICS, CYSTS (Pathology), LIVER diseases, TREATMENT effectiveness, DISEASE complications, PHARMACODYNAMICS
Abstract

The article offers information on the report on Autosomal dominant polycystic kidney disease (ADPKD). Topics discussed include information on the characterization of the ADPKD by the presence of multiple cysts residing in the kidneys and liver; discussions on the study reveals that pharmacokinetic suitability of ciprofloxacin for treatment of hepatic cyst infections; and the information on the study on cyst infection, confirmed by cyst fluid culture for E. coli and Klebsiella pneumoniae.

Published
2019
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24. Pharmacokinetics of Anidulafungin in Critically Ill Intensive Care Unit Patients with Suspected or Proven Invasive Fungal Infections

Author

Brüggemann, R. J. M., Middel-Baars, V., de Lange, D. W., Colbers, A., Girbes, A. R. J., Pickkers, P., and Swart, E. L.

Abstract

ABSTRACTEchinocandins, such as anidulafungin, are the first-line treatment for candidemia or invasive candidiasis in critically ill patients. There are conflicting data on the pharmacokinetic properties of anidulafungin in intensive care unit (ICU) patients. Adult ICU patients (from 3 hospitals) receiving anidulafungin for suspected or proven fungal infections were included in the present study. Patients were considered evaluable if a pharmacokinetic curve for day 3 could be completed. Twenty-three of 36 patients (7 female and 16 male) were evaluable. The median (range) age and body weight were 66 (28 to 88) years and 76 (50 to 115) kg, respectively. Pharmacokinetic sampling on day 3 (n= 23) resulted in a median anidulafungin area under the concentration-time curve from 0 to 24 h (AUC0–24) of 72.1 (interquartile range [IQR], 61.3 to 94.0) mg · h · liter−1, a median daily trough concentration (C24) of 2.2 (IQR, 1.9 to 2.9) mg/liter, a median maximum concentration of drug in serum (Cmax) of 5.3 (IQR, 4.1 to 6.0) mg/liter, a median volume of distribution (V) of 46.0 (IQR, 32.2 to 60.2) liters, and a median clearance (CL) of 1.4 (IQR, 1.1 to 1.6) liters · h−1. Pharmacokinetic sampling on day 7 (n= 13) resulted in a median AUC0–24of 82.7 (IQR, 73.0 to 129.5) mg · h · liter−1, a median minimum concentration of drug in serum (Cmin) of 2.8 (IQR, 2.2 to 4.2) mg/liter, a median Cmaxof 5.9 (IQR, 4.6 to 8.0) mg/liter, a median Vof 39.7 (IQR, 32.2 to 54.4) liters, and a median CL of 1.2 (IQR, 0.8 to 1.4) liters · h−1. The geometric mean ratio for the AUCday7/AUCday3term was 1.13 (90% confidence interval [CI], 1.03 to 1.25). The exposure in the ICU patient population was in accordance with previous reports on anidulafungin pharmacokinetics in ICU patients but was lower than that for healthy volunteers or other patient populations. Larger cohorts of patients or pooled data analyses are necessary to retrieve relevant covariates. (This study has been registered at ClinicalTrials.gov under identifier NCT01438216.)

Published
2016
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25. ESCMID-ECMM guideline: diagnosis and management of invasive aspergillosis in neonates and children.

Author

Warris A, Lehrnbecher T, Roilides E, Castagnola E, Brüggemann RJM, and Groll AH

Subjects
Antibiotic Prophylaxis methods, Antibiotic Prophylaxis standards, Aspergillus drug effects, Child, Disease Management, Drug Monitoring, Humans, Infant, Newborn, Antifungal Agents therapeutic use, Aspergillosis diagnosis, Aspergillosis drug therapy, Invasive Fungal Infections diagnosis, Invasive Fungal Infections drug therapy
Abstract

Scope: Presenting symptoms, distributions and patterns of diseases and vulnerability to invasive aspergillosis (IA) are similar between children and adults. However, differences exist in the epidemiology and underlying conditions, the usefulness of newer diagnostic tools, the pharmacology of antifungal agents and in the evidence from interventional phase 3 clinical trials. Therefore, the European Society for Clinical Microbiology and Infectious Diseases (ESCMID) and the European Confederation of Medical Mycology (ECMM) have developed a paediatric-specific guideline for the diagnosis and management of IA in neonates and children., Methods: Review and discussion of the scientific literature and grading of the available quality of evidence was performed by the paediatric subgroup of the ESCMID-ECMM-European Respiratory Society (ERS) Aspergillus disease guideline working group, which was assigned the mandate for the development of neonatal- and paediatric-specific recommendations., Questions: Questions addressed by the guideline included the epidemiology of IA in neonates and children; which paediatric patients may benefit from antifungal prophylaxis; how to diagnose IA in neonates and children; which antifungal agents are available for use in neonates and children; which antifungal agents are suitable for prophylaxis and treatment of IA in neonates and children; what is the role of therapeutic drug monitoring of azole antifungals; and which management strategies are suitable to be used in paediatric patients. This guideline provides recommendations for the diagnosis, prevention and treatment of IA in the paediatric population, including neonates. The aim of this guideline is to facilitate optimal management of neonates and children at risk for or diagnosed with IA., (Copyright © 2019 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Published
2019
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26. Diagnosis and management of Aspergillus diseases: executive summary of the 2017 ESCMID-ECMM-ERS guideline.

Author

Ullmann AJ, Aguado JM, Arikan-Akdagli S, Denning DW, Groll AH, Lagrou K, Lass-Flörl C, Lewis RE, Munoz P, Verweij PE, Warris A, Ader F, Akova M, Arendrup MC, Barnes RA, Beigelman-Aubry C, Blot S, Bouza E, Brüggemann RJM, Buchheidt D, Cadranel J, Castagnola E, Chakrabarti A, Cuenca-Estrella M, Dimopoulos G, Fortun J, Gangneux JP, Garbino J, Heinz WJ, Herbrecht R, Heussel CP, Kibbler CC, Klimko N, Kullberg BJ, Lange C, Lehrnbecher T, Löffler J, Lortholary O, Maertens J, Marchetti O, Meis JF, Pagano L, Ribaud P, Richardson M, Roilides E, Ruhnke M, Sanguinetti M, Sheppard DC, Sinkó J, Skiada A, Vehreschild MJGT, Viscoli C, and Cornely OA

Subjects
Antibodies, Fungal blood, Antifungal Agents pharmacology, Aspergillosis complications, Aspergillosis immunology, Aspergillus drug effects, Aspergillus immunology, Biopsy methods, Bronchoalveolar Lavage, Early Diagnosis, Flucytosine pharmacology, Flucytosine therapeutic use, Galactose analogs & derivatives, Humans, Immunocompromised Host, Immunologic Tests, Invasive Pulmonary Aspergillosis diagnosis, Itraconazole pharmacology, Itraconazole therapeutic use, Leukemia, Myeloid, Acute complications, Leukemia, Myeloid, Acute therapy, Magnetic Resonance Imaging, Mannans analysis, Microbial Sensitivity Tests, Myelodysplastic Syndromes complications, Myelodysplastic Syndromes therapy, Nitriles pharmacology, Nitriles therapeutic use, Pyridines pharmacology, Pyridines therapeutic use, Tomography, X-Ray Computed, Triazoles pharmacology, Triazoles therapeutic use, Voriconazole pharmacology, Voriconazole therapeutic use, Antifungal Agents therapeutic use, Aspergillosis diagnosis, Aspergillosis drug therapy, Aspergillus isolation & purification, Disease Management
Abstract

The European Society for Clinical Microbiology and Infectious Diseases, the European Confederation of Medical Mycology and the European Respiratory Society Joint Clinical Guidelines focus on diagnosis and management of aspergillosis. Of the numerous recommendations, a few are summarized here. Chest computed tomography as well as bronchoscopy with bronchoalveolar lavage (BAL) in patients with suspicion of pulmonary invasive aspergillosis (IA) are strongly recommended. For diagnosis, direct microscopy, preferably using optical brighteners, histopathology and culture are strongly recommended. Serum and BAL galactomannan measures are recommended as markers for the diagnosis of IA. PCR should be considered in conjunction with other diagnostic tests. Pathogen identification to species complex level is strongly recommended for all clinically relevant Aspergillus isolates; antifungal susceptibility testing should be performed in patients with invasive disease in regions with resistance found in contemporary surveillance programmes. Isavuconazole and voriconazole are the preferred agents for first-line treatment of pulmonary IA, whereas liposomal amphotericin B is moderately supported. Combinations of antifungals as primary treatment options are not recommended. Therapeutic drug monitoring is strongly recommended for patients receiving posaconazole suspension or any form of voriconazole for IA treatment, and in refractory disease, where a personalized approach considering reversal of predisposing factors, switching drug class and surgical intervention is also strongly recommended. Primary prophylaxis with posaconazole is strongly recommended in patients with acute myelogenous leukaemia or myelodysplastic syndrome receiving induction chemotherapy. Secondary prophylaxis is strongly recommended in high-risk patients. We strongly recommend treatment duration based on clinical improvement, degree of immunosuppression and response on imaging., (Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Published
2018
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27. Plasma concentrations of caspofungin at two different dosage regimens in a patient with hepatic dysfunction.

Author

van der Elst KC, Brüggemann RJ, Rodgers MG, and Alffenaar JW

Subjects
Antifungal Agents adverse effects, Aspergillosis microbiology, Caspofungin, Dose-Response Relationship, Drug, Drug Administration Schedule, Echinocandins adverse effects, Female, Humans, Lipopeptides, Liver Diseases drug therapy, Liver Diseases microbiology, Middle Aged, Treatment Outcome, Antifungal Agents administration & dosage, Antifungal Agents pharmacokinetics, Aspergillosis drug therapy, Echinocandins administration & dosage, Echinocandins pharmacokinetics, Liver Diseases complications, Liver Transplantation adverse effects
Abstract

The currently recommended dosage regimen of caspofungin (50 mg/day) was developed for patients with invasive candidiasis. With invasive aspergillosis, successful outcomes occur in less than half the patients. We evaluate the pharmacokinetics in a patient with elevated liver enzyme levels after liver transplantation, who received caspofungin for the treatment of aspergillosis. Plasma concentrations of caspofungin were monitored at 2 different dosage regimens. The area under the concentration-time curve (AUC) at a dosage of 70 mg was 191 mg h/L and was associated with an increase in liver enzymes. After dose reduction to 50 mg with an AUC of 100 mg h/L, liver enzymes normalized. In conclusion, caspofungin plasma concentrations may be helpful to evaluate exposure and reduce the need for off-label dosing., (© 2012 John Wiley & Sons A/S.)

Published
2012
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28. Simultaneous determination of the azoles voriconazole, posaconazole, isavuconazole, itraconazole and its metabolite hydroxy-itraconazole in human plasma by reversed phase ultra-performance liquid chromatography with ultraviolet detection.

Author

Wissen CP, Burger DM, Verweij PE, Aarnoutse RE, and Brüggemann RJ

Subjects
Antifungal Agents blood, Drug Monitoring, Drug Stability, Humans, Reproducibility of Results, Sensitivity and Specificity, Spectrophotometry, Ultraviolet, Chromatography, High Pressure Liquid methods, Chromatography, Reverse-Phase methods, Triazoles blood
Abstract

A reversed phase ultra-performance liquid chromatography method was developed for the simultaneous quantitative determination of the systemically administered azoles voriconazole, posaconazole, isavuconazole, itraconazole and its metabolite hydroxy-itraconazole in plasma. The method involved a simple liquid-liquid extraction followed by ultra-performance liquid chromatography with an Acquity UPLC BEH Phenyl column and ultraviolet detection set at a wavelength of 260 nm. The assay was validated over the concentration range of 0.050-10,000 mg/l for all four azoles and one metabolite. The accuracies for the assay were 97-104%, inter- and intra-day coefficients of variation were <7.5% and extraction recoveries were 98% for voriconazole, posaconazole, isavuconazole and the internal standard (UK115794), and 79% and 88% for itraconazole and hydroxy-itraconazole respectively. This method proved to be simple, accurate, precise and fast and is currently in use in our laboratory for the quantitative analysis of these azoles for Therapeutic Drug Monitoring and pharmacokinetic research., (Copyright © 2012 Elsevier B.V. All rights reserved.)

Published
2012
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