Liquid Chromatography-Tandem Mass Spectrometry Method for Therapeutic Drug Monitoring of Dalbavancin in Plasma of Pediatric and Young Adult Patients.
Journal
Therapeutic drug monitoring
ISSN: 1536-3694
Titre abrégé: Ther Drug Monit
Pays: United States
ID NLM: 7909660
Informations de publication
Date de publication:
10 Oct 2024
10 Oct 2024
Historique:
received:
02
03
2024
accepted:
20
07
2024
medline:
23
10
2024
pubmed:
23
10
2024
entrez:
22
10
2024
Statut:
aheadofprint
Résumé
Dalbavancin, an antimicrobial lipoglycopeptide, is authorized in Europe for treating acute bacterial infections of the skin and skin structures in adults and pediatric patients aged 3 months and older. However, off-label dosing regimens have been proposed for various indications beyond acute bacterial infections of the skin and skin structures. This study presents a novel bioanalytical method using liquid chromatography-tandem mass spectrometry to quantify dalbavancin in low-volume plasma samples (50 μL). The method underwent validation in accordance with international guidelines for bioanalytical method validation and was applied to 9 clinical samples obtained from pediatric and young adult patients undergoing dalbavancin therapy. Liquid chromatography-tandem mass spectrometry analyses were conducted at the G. Gaslini Institute in Genoa, Italy, utilizing an Ultimate 3000 ultra high performance liquid chromatography system coupled to a TSQ Quantiva Triple Quadrupole system (Thermo Fisher Scientific, Milan, Italy). The analytical procedure involved the addition of deuterated dalbavancin as internal standard and a rapid extraction from 50 µL of human plasma, followed by chromatographic separation on a Thermo Scientific Accucore Polar Premium column. Accurate quantification of the analyte was achieved through multiple reaction monitoring detection. The assay exhibited linearity within the concentration range of 0.66-400 mcg/mL in plasma, demonstrating accuracy and reproducibility in the absence of matrix effects. Stability testing was conducted on both quality controls and real samples to establish a robust protocol under real-life conditions. This fast and reliable dalbavancin quantitation method could improve current pediatric clinical practice by enabling data collection for future dose recommendations in special patient populations.
Sections du résumé
BACKGROUND
BACKGROUND
Dalbavancin, an antimicrobial lipoglycopeptide, is authorized in Europe for treating acute bacterial infections of the skin and skin structures in adults and pediatric patients aged 3 months and older. However, off-label dosing regimens have been proposed for various indications beyond acute bacterial infections of the skin and skin structures. This study presents a novel bioanalytical method using liquid chromatography-tandem mass spectrometry to quantify dalbavancin in low-volume plasma samples (50 μL).
METHODS
METHODS
The method underwent validation in accordance with international guidelines for bioanalytical method validation and was applied to 9 clinical samples obtained from pediatric and young adult patients undergoing dalbavancin therapy. Liquid chromatography-tandem mass spectrometry analyses were conducted at the G. Gaslini Institute in Genoa, Italy, utilizing an Ultimate 3000 ultra high performance liquid chromatography system coupled to a TSQ Quantiva Triple Quadrupole system (Thermo Fisher Scientific, Milan, Italy). The analytical procedure involved the addition of deuterated dalbavancin as internal standard and a rapid extraction from 50 µL of human plasma, followed by chromatographic separation on a Thermo Scientific Accucore Polar Premium column. Accurate quantification of the analyte was achieved through multiple reaction monitoring detection.
RESULTS
RESULTS
The assay exhibited linearity within the concentration range of 0.66-400 mcg/mL in plasma, demonstrating accuracy and reproducibility in the absence of matrix effects. Stability testing was conducted on both quality controls and real samples to establish a robust protocol under real-life conditions.
CONCLUSIONS
CONCLUSIONS
This fast and reliable dalbavancin quantitation method could improve current pediatric clinical practice by enabling data collection for future dose recommendations in special patient populations.
Identifiants
pubmed: 39437539
doi: 10.1097/FTD.0000000000001260
pii: 00007691-990000000-00271
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors declare no conflict of interest.
Références
Xydalba. European Medicines Agency. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/xydalba. Accessed April 3, 2024.
Barberán J, de la Cuerda A, Barberán LC. Dalbavancin. Rev Esp Quimioter. 2021;34(suppl 1):26–28.
Gatti M, Andreoni M, Pea F, et al. Real-world use of dalbavancin in the era of empowerment of outpatient antimicrobial treatment: a careful appraisal beyond approved indications focusing on unmet clinical needs. Drug Des Devel Ther. 2021;15:3349–3378.
Cafaro A, Barco S, Pigliasco F, et al. Therapeutic drug monitoring of glycopeptide antimicrobials: an overview of liquid chromatography-tandem mass spectrometry methods. J Mass Spectrom Adv Clin Lab. 2023;31:33–39.
Cattaneo D, Corona A, De Rosa FG, et al. The management of anti-infective agents in intensive care units: the potential role of a “fast” pharmacology. Expert Rev Clin Pharmacol. 2020;13:355–366.
Castagnola E, Cangemi G, Mesini A, et al. Pharmacokinetics and pharmacodynamics of antibiotics in cystic fibrosis: a narrative review. Int J Antimicrob Agents. 2021;58:106381.
Cangemi G, Barbagallo L, Cafaro A, et al. Indications for the harmonization of the therapeutic intervals of antibacterial drugs. Biochim Clin. 2022;46:347–353.
The European Committee on Antimicrobial Susceptibility Testing. Breakpoint Tables for Interpretation of MICs and Zone Diameters, Version 10.0, 2020 2020, 0–77. Available at: https://www.eucast.org/clinical_breakpoints. Accessed October 6, 2023.
Lin G, Credito K, Ednie LM, et al. Antistaphylococcal activity of dalbavancin, an experimental glycopeptide. Antimicrob Agents Chemother. 2005;49:770–772.
Goldstein BP, Draghi DC, Sheehan DJ, et al. Bactericidal activity and resistance development profiling of dalbavancin. Antimicrob Agents Chemother. 2007;51:1150–1154.
Lepak A, Marchillo K, VanHecker J, et al. Impact of glycopeptide resistance in Staphylococcus aureus on the dalbavancin in vivo pharmacodynamic target. Antimicrob Agents Chemother. 2015;59:7833–7836.
Andes D, Craig WA. In vivo pharmacodynamic activity of the glycopeptide dalbavancin. Antimicrob Agents Chemother. 2007;51:1633–1642.
Landi F, Bandettini R, Rotulo GA, et al. Resistance to antibiotics of uropathogen bacteria isolated from urine and blood in pediatric cancer patients: a single center, 12-year study. Pediatr Infect Dis J. 2020;39:1106–1110.
Pea F. Teicoplanin and therapeutic drug monitoring: an update for optimal use in different patient populations. J Infect Chemother. 2020;26:900–907.
Cafaro A, Stella M, Mesini A, et al. Dose optimization and target attainment of vancomycin in children. Clin Biochem. 2024;125:110728.
Turner NA, Xu A, Zaharoff S, et al. Determination of plasma protein binding of dalbavancin. J Antimicrob Chemother. 2022;77:1899–1902.
Dunne MW, Puttagunta S, Sprenger CR, et al. Extended-duration dosing and distribution of dalbavancin into bone and articular tissue. Antimicrob Agents Chemother. 2015;59:1849–1855.
ICH M10 on Bioanalytical Method Validation - Scientific Guideline. European Medicines Agency. Available at: https://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validation-scientific-guideline. Accessed April 3, 2024.
Senneville E, Cuervo G, Gregoire M, et al. Expert opinion on dose regimen and therapeutic drug monitoring for long-term use of dalbavancin: expert review panel. Int J Antimicrob Agents. 2023;62:106960.
Cojutti PG, Rinaldi M, Gatti M, et al. Usefulness of therapeutic drug monitoring in estimating the duration of dalbavancin optimal target attainment in staphylococcal osteoarticular infections: a proof-of-concept. Int J Antimicrob Agents. 2021;58:106445.
Cojutti PG, Tedeschi S, Gatti M, et al. Population pharmacokinetic and pharmacodynamic analysis of dalbavancin for long-term treatment of subacute and/or chronic infectious diseases: the major role of therapeutic drug monitoring. Antibiotics. 2022;11:996.
Corona A, Agarossi A, Veronese A, et al. Therapeutic drug monitoring of dalbavancin treatment in severe necrotizing fasciitis in 3 critically ill patients: a grand round. Ther Drug Monit. 2020;42:165–168.
Gatti M, Viale P, Cojutti PG, et al. A descriptive case series of the relationship between maintenance of conservative PK/PD efficacy thresholds of dalbavancin over time and clinical outcome in long-term treatment of staphylococcal osteoarticular infections. Int J Antimicrob Agents. 2023;61:106773.
Matuszewski BK, Constanzer ML, Chavez-Eng CM. Strategies for the assessment of matrix effect in quantitative bioanalytical methods based on HPLC-MS/MS. Anal Chem. 2003;75:3019–3030.
Pea F. Plasma pharmacokinetics of antimicrobial agents in critically ill patients. Curr Clin Pharmacol. 2013;8:5–12.
Carcione D, Intra J, Andriani L, et al. New antimicrobials for gram-positive sustained infections: a comprehensive guide for clinicians. Pharmaceuticals (Basel). 2023;16:1304.
Baiardi G, Caviglia MC, Piras F, et al. The clinical efficacy of multidose oritavancin: a systematic review. Antibiotics (Basel). 2023;12:1498.
Cafaro A, Conti M, Pigliasco F, et al. Biological fluid microsampling for therapeutic drug monitoring: a narrative review. Biomedicines. 2023;11:1962.
Chiriac U, Rau H, Frey OR, et al. Validation and application of an HPLC-UV method for routine therapeutic drug monitoring of dalbavancin. Antibiotics (Basel). 2022;11:541.
Destere A, Merino D, Bonesso L, et al. A HPLC-DAD method to facilitate large-scale therapeutic drug monitoring of dalbavancin. J Chromatogr B Analyt Technol Biomed Life Sci. 2023;1222:123694.
Avataneo V, Antonucci M, De Vivo ED, et al. Validation and clinical application of a new liquid chromatography coupled to mass spectrometry (HPLC-S) method for dalbavancin quantification in human plasma. Separations. 2021;8:189.
Seraissol P, Lanot T, Baklouti S, et al. Evaluation of 4 quantification methods for monitoring 16 antibiotics and 1 beta-lactamase inhibitor in human serum by high-performance liquid chromatography with tandem mass spectrometry detection. J Pharm Biomed Anal. 2022;219:114900.
Alebic-Kolbah T, Demers R, Cojocaru L. Dalbavancin: quantification in human plasma and urine by a new improved high performance liquid chromatography-tandem mass spectrometry method. J Chromatogr B Analyt Technol Biomed Life Sci. 2011;879:2632–2641.
Mula J, Chiara F, Manca A, et al. Analytical validation of a novel UHPLC-MS/MS method for 19 antibiotics quantification in plasma: implementation in a LC-MS/MS Kit. Biomed Pharmacother. 2023;163:114790.
Barone R, Conti M, Cojutti PG, et al. Fast and simple liquid chromatography-isotope dilution tandem mass spectrometry method for therapeutic drug monitoring of dalbavancin in long-term treatment of subacute and/or chronic infections. Pharmaceutics. 2023;15:480.
Polson C, Sarkar P, Incledon B, et al. Optimization of protein precipitation based upon effectiveness of protein removal and ionization effect in liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2003;785:263–275.
Esposito S, Bianchini S. Dalbavancin for the treatment of paediatric infectious diseases. Eur J Clin Microbiol Infect Dis. 2016;35:1895–1901.
Bradley JS, Puttagunta S, Rubino CM, et al. Pharmacokinetics, safety and tolerability of single dose dalbavancin in children 12-17 years of age. Pediatr Infect Dis J. 2015;34:748–752.
Gonzalez D, Bradley JS, Blumer J, et al. Dalbavancin pharmacokinetics and safety in children 3 months to 11 years of age. Pediatr Infect Dis J. 2017;36:645–653.
Carrothers TJ, Lagraauw HM, Lindbom L, et al. Population pharmacokinetic and pharmacokinetic/pharmacodynamic target attainment analyses for dalbavancin in pediatric patients. Pediatr Infect Dis J. 2023;42:99–105.