Pharmacokinetics of dalbavancin in plasma and skin blister fluid
Objectives Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria. The aim of the present study was to assess the penetration of dalbavancin into skin blister fluid. Methods Nine...
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| Published in | Journal of antimicrobial chemotherapy Vol. 60; no. 3; pp. 681 - 684 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford
Oxford University Press
01.09.2007
Oxford Publishing Limited (England) |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0305-7453 1460-2091 |
| DOI | 10.1093/jac/dkm263 |
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| Abstract | Objectives Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria. The aim of the present study was to assess the penetration of dalbavancin into skin blister fluid. Methods Nine healthy subjects (five males; ranging in age from 26 to 57 years) were administered a single 30 min intravenous infusion of dalbavancin at a dose of 1000 mg. Skin blisters were induced by application of cantharidin ointment. Plasma and blister fluid samples were collected over 7 days post-dose, and concentrations of dalbavancin were assessed by a validated LC/MS/MS assay. Pharmacokinetics were determined by non-compartmental methods, and drug penetration was assessed based on the ratio of area under the curve (AUC) in the blister fluid versus plasma for each subject. Results The mean (SD) peak concentration of dalbavancin in plasma and blister fluid was 285 (31.1) and 67.3 (18.2) mg/L, respectively; the corresponding AUCDay 7 values were 10 806 (1926) and 6438 (1238) mg · h/L, respectively. The mean (SD) penetration of dalbavancin into blister fluid was 59.6% (6.3%). By Day 7, the mean concentration of dalbavancin in plasma and blister fluid was 46.5 and 30.3 mg/L, respectively. Conclusions Dalbavancin concentrations in blister fluid remained well above the MIC90 values for pathogens commonly implicated in cSSSIs such as Staphylococcus aureus, including methicillin-resistant S. aureus (MIC90 = 0.06 mg/L) and β-haemolytic streptococci (MIC90 = 0.03 mg/L) through Day 7. These pharmacokinetic data support the use of dalbavancin in the treatment of cSSSIs caused by susceptible Gram-positive pathogens. |
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| AbstractList | Objectives Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria. The aim of the present study was to assess the penetration of dalbavancin into skin blister fluid. Methods Nine healthy subjects (five males; ranging in age from 26 to 57 years) were administered a single 30 min intravenous infusion of dalbavancin at a dose of 1000 mg. Skin blisters were induced by application of cantharidin ointment. Plasma and blister fluid samples were collected over 7 days post-dose, and concentrations of dalbavancin were assessed by a validated LC/MS/MS assay. Pharmacokinetics were determined by non-compartmental methods, and drug penetration was assessed based on the ratio of area under the curve (AUC) in the blister fluid versus plasma for each subject. Results The mean (SD) peak concentration of dalbavancin in plasma and blister fluid was 285 (31.1) and 67.3 (18.2) mg/L, respectively; the corresponding AUCDay 7 values were 10 806 (1926) and 6438 (1238) mg · h/L, respectively. The mean (SD) penetration of dalbavancin into blister fluid was 59.6% (6.3%). By Day 7, the mean concentration of dalbavancin in plasma and blister fluid was 46.5 and 30.3 mg/L, respectively. Conclusions Dalbavancin concentrations in blister fluid remained well above the MIC90 values for pathogens commonly implicated in cSSSIs such as Staphylococcus aureus, including methicillin-resistant S. aureus (MIC90 = 0.06 mg/L) and β-haemolytic streptococci (MIC90 = 0.03 mg/L) through Day 7. These pharmacokinetic data support the use of dalbavancin in the treatment of cSSSIs caused by susceptible Gram-positive pathogens. Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria. The aim of the present study was to assess the penetration of dalbavancin into skin blister fluid. Nine healthy subjects (five males; ranging in age from 26 to 57 years) were administered a single 30 min intravenous infusion of dalbavancin at a dose of 1000 mg. Skin blisters were induced by application of cantharidin ointment. Plasma and blister fluid samples were collected over 7 days post-dose, and concentrations of dalbavancin were assessed by a validated LC/MS/MS assay. Pharmacokinetics were determined by non-compartmental methods, and drug penetration was assessed based on the ratio of area under the curve (AUC) in the blister fluid versus plasma for each subject. The mean (SD) peak concentration of dalbavancin in plasma and blister fluid was 285 (31.1) and 67.3 (18.2) mg/L, respectively; the corresponding AUC(Day 7) values were 10 806 (1926) and 6438 (1238) mg . h/L, respectively. The mean (SD) penetration of dalbavancin into blister fluid was 59.6% (6.3%). By Day 7, the mean concentration of dalbavancin in plasma and blister fluid was 46.5 and 30.3 mg/L, respectively. Dalbavancin concentrations in blister fluid remained well above the MIC90 values for pathogens commonly implicated in cSSSIs such as Staphylococcus aureus, including methicillin-resistant S. aureus (MIC90 = 0.06 mg/L) and beta-haemolytic streptococci (MIC90 = 0.03 mg/L) through Day 7. These pharmacokinetic data support the use of dalbavancin in the treatment of cSSSIs caused by susceptible Gram-positive pathogens. Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria. The aim of the present study was to assess the penetration of dalbavancin into skin blister fluid.OBJECTIVESDalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria. The aim of the present study was to assess the penetration of dalbavancin into skin blister fluid.Nine healthy subjects (five males; ranging in age from 26 to 57 years) were administered a single 30 min intravenous infusion of dalbavancin at a dose of 1000 mg. Skin blisters were induced by application of cantharidin ointment. Plasma and blister fluid samples were collected over 7 days post-dose, and concentrations of dalbavancin were assessed by a validated LC/MS/MS assay. Pharmacokinetics were determined by non-compartmental methods, and drug penetration was assessed based on the ratio of area under the curve (AUC) in the blister fluid versus plasma for each subject.METHODSNine healthy subjects (five males; ranging in age from 26 to 57 years) were administered a single 30 min intravenous infusion of dalbavancin at a dose of 1000 mg. Skin blisters were induced by application of cantharidin ointment. Plasma and blister fluid samples were collected over 7 days post-dose, and concentrations of dalbavancin were assessed by a validated LC/MS/MS assay. Pharmacokinetics were determined by non-compartmental methods, and drug penetration was assessed based on the ratio of area under the curve (AUC) in the blister fluid versus plasma for each subject.The mean (SD) peak concentration of dalbavancin in plasma and blister fluid was 285 (31.1) and 67.3 (18.2) mg/L, respectively; the corresponding AUC(Day 7) values were 10 806 (1926) and 6438 (1238) mg . h/L, respectively. The mean (SD) penetration of dalbavancin into blister fluid was 59.6% (6.3%). By Day 7, the mean concentration of dalbavancin in plasma and blister fluid was 46.5 and 30.3 mg/L, respectively.RESULTSThe mean (SD) peak concentration of dalbavancin in plasma and blister fluid was 285 (31.1) and 67.3 (18.2) mg/L, respectively; the corresponding AUC(Day 7) values were 10 806 (1926) and 6438 (1238) mg . h/L, respectively. The mean (SD) penetration of dalbavancin into blister fluid was 59.6% (6.3%). By Day 7, the mean concentration of dalbavancin in plasma and blister fluid was 46.5 and 30.3 mg/L, respectively.Dalbavancin concentrations in blister fluid remained well above the MIC90 values for pathogens commonly implicated in cSSSIs such as Staphylococcus aureus, including methicillin-resistant S. aureus (MIC90 = 0.06 mg/L) and beta-haemolytic streptococci (MIC90 = 0.03 mg/L) through Day 7. These pharmacokinetic data support the use of dalbavancin in the treatment of cSSSIs caused by susceptible Gram-positive pathogens.CONCLUSIONSDalbavancin concentrations in blister fluid remained well above the MIC90 values for pathogens commonly implicated in cSSSIs such as Staphylococcus aureus, including methicillin-resistant S. aureus (MIC90 = 0.06 mg/L) and beta-haemolytic streptococci (MIC90 = 0.03 mg/L) through Day 7. These pharmacokinetic data support the use of dalbavancin in the treatment of cSSSIs caused by susceptible Gram-positive pathogens. OBJECTIVES: Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria. The aim of the present study was to assess the penetration of dalbavancin into skin blister fluid. METHODS: Nine healthy subjects (five males; ranging in age from 26 to 57 years) were administered a single 30 min intravenous infusion of dalbavancin at a dose of 1000 mg. Skin blisters were induced by application of cantharidin ointment. Plasma and blister fluid samples were collected over 7 days post-dose, and concentrations of dalbavancin were assessed by a validated LC/MS/MS assay. Pharmacokinetics were determined by non-compartmental methods, and drug penetration was assessed based on the ratio of area under the curve (AUC) in the blister fluid versus plasma for each subject. RESULTS: The mean (SD) peak concentration of dalbavancin in plasma and blister fluid was 285 (31.1) and 67.3 (18.2) mg/L, respectively; the corresponding AUC sub(Day 7) values were 10 806 (1926) and 6438 (1238) mg . h/L, respectively. The mean (SD) penetration of dalbavancin into blister fluid was 59.6% (6.3%). By Day 7, the mean concentration of dalbavancin in plasma and blister fluid was 46.5 and 30.3 mg/L, respectively. CONCLUSIONS: Dalbavancin concentrations in blister fluid remained well above the MIC sub(90) values for pathogens commonly implicated in cSSSIs such as Staphylococcus aureus, including methicillin-resistant S. aureus (MIC sub(90) = 0.06 mg/L) and {szligbeta}-haemolytic streptococci (MIC sub(90) = 0.03 mg/L) through Day 7. These pharmacokinetic data support the use of dalbavancin in the treatment of cSSSIs caused by susceptible Gram-positive pathogens. Objectives Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria. The aim of the present study was to assess the penetration of dalbavancin into skin blister fluid. Methods Nine healthy subjects (five males; ranging in age from 26 to 57 years) were administered a single 30 min intravenous infusion of dalbavancin at a dose of 1000 mg. Skin blisters were induced by application of cantharidin ointment. Plasma and blister fluid samples were collected over 7 days post-dose, and concentrations of dalbavancin were assessed by a validated LC/MS/MS assay. Pharmacokinetics were determined by non-compartmental methods, and drug penetration was assessed based on the ratio of area under the curve (AUC) in the blister fluid versus plasma for each subject. Results The mean (SD) peak concentration of dalbavancin in plasma and blister fluid was 285 (31.1) and 67.3 (18.2) mg/L, respectively; the corresponding AUCDay 7 values were 10 806 (1926) and 6438 (1238) mg · h/L, respectively. The mean (SD) penetration of dalbavancin into blister fluid was 59.6% (6.3%). By Day 7, the mean concentration of dalbavancin in plasma and blister fluid was 46.5 and 30.3 mg/L, respectively. Conclusions Dalbavancin concentrations in blister fluid remained well above the MIC90 values for pathogens commonly implicated in cSSSIs such as Staphylococcus aureus, including methicillin-resistant S. aureus (MIC90 = 0.06 mg/L) and β-haemolytic streptococci (MIC90 = 0.03 mg/L) through Day 7. These pharmacokinetic data support the use of dalbavancin in the treatment of cSSSIs caused by susceptible Gram-positive pathogens. Objectives: Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria. The aim of the present study was to assess the penetration of dalbavancin into skin blister fluid. Methods: Nine healthy subjects (five males; ranging in age from 26 to 57 years) were administered a single 30 min intravenous infusion of dalbavancin at a dose of 1000 mg. Skin blisters were induced by application of cantharidin ointment. Plasma and blister fluid samples were collected over 7 days post-dose, and concentrations of dalbavancin were assessed by a validated LC/MS/MS assay. Pharmacokinetics were determined by non-compartmental methods, and drug penetration was assessed based on the ratio of area under the curve (AUC) in the blister fluid versus plasma for each subject. Results: The mean (SD) peak concentration of dalbavancin in plasma and blister fluid was 285 (31.1) and 67.3 (18.2) mg/L, respectively; the corresponding AUCDay 7 values were 10 806 (1926) and 6438 (1238) mg . h/L, respectively. The mean (SD) penetration of dalbavancin into blister fluid was 59.6% (6.3%). By Day 7, the mean concentration of dalbavancin in plasma and blister fluid was 46.5 and 30.3 mg/L, respectively. Conclusions: Dalbavancin concentrations in blister fluid remained well above the MIC90 values for pathogens commonly implicated in cSSSIs such as Staphylococcus aureus, including methicillin-resistant S. aureus (MIC90 = 0.06 mg/L) and ß-haemolytic streptococci (MIC90 = 0.03 mg/L) through Day 7. These pharmacokinetic data support the use of dalbavancin in the treatment of cSSSIs caused by susceptible Gram-positive pathogens. [PUBLICATION ABSTRACT] |
| Author | Dowell, James A. Sun, Heather K. Seltzer, Elyse Nicolau, David P. Buckwalter, Mary |
| Author_xml | – sequence: 1 givenname: David P. surname: Nicolau fullname: Nicolau, David P. email: dnicola@harthosp.org, Correspondence address. Center for Anti-Infective Research and Development, Hartford Hospital, 80 Seymour Street, Hartford, CT 06102-5037, USA. Tel: +1-860-545-3941; Fax: +1-860-545-3992; dnicola@harthosp.org organization: Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, CT 06102, USA – sequence: 2 givenname: Heather K. surname: Sun fullname: Sun, Heather K. organization: Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, CT 06102, USA – sequence: 3 givenname: Elyse surname: Seltzer fullname: Seltzer, Elyse organization: Vicuron Pharmaceuticals, King of Prussia, PA 19406, USA – sequence: 4 givenname: Mary surname: Buckwalter fullname: Buckwalter, Mary organization: Vicuron Pharmaceuticals, King of Prussia, PA 19406, USA – sequence: 5 givenname: James A. surname: Dowell fullname: Dowell, James A. organization: Vicuron Pharmaceuticals, King of Prussia, PA 19406, USA |
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| Copyright | The Author 2007. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org 2007 2007 INIST-CNRS The Author 2007. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org |
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| Keywords | lipoglycopeptides infections cSSSIs Bullous dermatosis Biological fluid Skin disease Skin bulla Peptides Blood plasma Infection Antibiotic Glycopeptide Dalbavancin Antibacterial agent Pharmacokinetics |
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| References | Streit ( key 20171010171313_DKM263C2) 2005; 53 Sun ( key 20171010171313_DKM263C14) 2006; 50 Dowell ( key 20171010171313_DKM263C6) Candiani ( key 20171010171313_DKM263C3) 1999; 44 key 20171010171313_DKM263C10 Cavaleri ( key 20171010171313_DKM263C9) 2005; 55 Fetterly ( key 20171010171313_DKM263C15) 2005; 49 Leighton ( key 20171010171313_DKM263C12) 2004; 48 Anderson ( key 20171010171313_DKM263C1) 1965; 53 Jauregui ( key 20171010171313_DKM263C16) 2005; 41 Seltzer ( key 20171010171313_DKM263C4) 2003; 37 Andes ( key 20171010171313_DKM263C13) Streit ( key 20171010171313_DKM263C5) 2004; 48 Stogniew ( key 20171010171313_DKM263C7) 2003; 9 Dorr ( key 20171010171313_DKM263C8) 2005; 55 Maglio ( key 20171010171313_DKM263C11) 2003; 22 |
| References_xml | – volume: 50 start-page: 788 year: 2006 ident: key 20171010171313_DKM263C14 article-title: Tissue penetration of telavancin after intravenous administration in healthy subjects publication-title: Antimicrob Agents Chemother doi: 10.1128/AAC.50.2.788-790.2006 – volume: 53 start-page: 307 year: 2005 ident: key 20171010171313_DKM263C2 article-title: Dalbavancin activity against selected populations of antimicrobial-resistant Gram-positive pathogens publication-title: Diagn Microbiol Infect Dis doi: 10.1016/j.diagmicrobio.2005.03.004 – ident: key 20171010171313_DKM263C10 – volume-title: Abstracts of the Forty-second Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA, 2002 ident: key 20171010171313_DKM263C6 article-title: The pharmacokinetics and renal excretion of dalbavancin in healthy subjects – volume: 53 start-page: 881 year: 1965 ident: key 20171010171313_DKM263C1 article-title: Lipid-phosphoacetylmuramyl-pentapeptide and lipid-phosphodisaccharide-pentapeptide: presumed membrane transport intermediates in cell wall synthesis publication-title: Proc Natl Acad Sci USA doi: 10.1073/pnas.53.4.881 – volume: 55 start-page: ii31 issue: Suppl 2 year: 2005 ident: key 20171010171313_DKM263C9 article-title: Pharmacokinetics and excretion of dalbavancin in the rat publication-title: J Antimicrob Chemother doi: 10.1093/jac/dki006 – volume: 49 start-page: 148 year: 2005 ident: key 20171010171313_DKM263C15 article-title: Pharmacokinetics of oritavancin in plasma skin blister fluid following administration of a 200-milligram dose for 3 days or a single 800-milligram dose publication-title: Antimicrob Agents Chemother doi: 10.1128/AAC.49.1.148-152.2005 – volume: 37 start-page: 1298 year: 2003 ident: key 20171010171313_DKM263C4 article-title: Once-weekly dalbavancin versus standard-of-care antimicrobial regimens for treatment of skin and soft-tissue infections publication-title: Clin Infect Dis doi: 10.1086/379015 – volume: 48 start-page: 137 year: 2004 ident: key 20171010171313_DKM263C5 article-title: Worldwide assessment of dalbavancin activity spectrum against over 6000 clinical isolates publication-title: Diagn Microbiol Infect Dis doi: 10.1016/j.diagmicrobio.2003.09.004 – volume: 55 start-page: ii25 issue: Suppl 2 year: 2005 ident: key 20171010171313_DKM263C8 article-title: Human pharmacokinetics and rationale for once-weekly dosing of dalbavancin, a semi-synthetic glycopeptide publication-title: J Antimicrob Chemother doi: 10.1093/jac/dki008 – volume: 44 start-page: 179 year: 1999 ident: key 20171010171313_DKM263C3 article-title: In-vitro and in-vivo antibacterial activity of BI 397 a new semi-synthetic glycopeptide antibiotic publication-title: J Antimicrob Chemother doi: 10.1093/jac/44.2.179 – volume: 48 start-page: 940 year: 2004 ident: key 20171010171313_DKM263C12 article-title: Tolerability, pharmacokinetics and serum bactericidal activity of intravenous dalbavancin in healthy volunteers publication-title: Antimicrob Agents Chemother doi: 10.1128/AAC.48.3.940-945.2004 – volume: 41 start-page: 1407 year: 2005 ident: key 20171010171313_DKM263C16 article-title: Randomized, double-blind comparison of once-weekly dalbavancin versus twice-daily linezolid therapy for the treatment of complicated skin and skin structure infections publication-title: Clin Infect Dis doi: 10.1086/497271 – volume-title: Abstracts of the Forty-fourth Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, 2004 ident: key 20171010171313_DKM263C13 article-title: In vivo pharmacodynamic characterization of dalbavancin (DAL) in the murine thigh infection model – volume: 22 start-page: 77 year: 2003 ident: key 20171010171313_DKM263C11 article-title: Production and resolution of cantharidin-induced inflammatory blisters publication-title: Int J Antimicrob Agents doi: 10.1016/S0924-8579(03)00084-0 – volume: 9 start-page: 291 issue: Suppl 1 year: 2003 ident: key 20171010171313_DKM263C7 article-title: Attributes of dalbavancin: well distributed and completely eliminated publication-title: Clin Microbiol Infect |
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| Snippet | Objectives Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs)... Objectives Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs)... Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs) caused by... Objectives: Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs)... OBJECTIVES: Dalbavancin is a novel lipoglycopeptide antibiotic in development for the treatment of complicated skin and skin structure infections (cSSSIs)... |
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| SubjectTerms | Adult Anti-Bacterial Agents - adverse effects Anti-Bacterial Agents - blood Anti-Bacterial Agents - pharmacokinetics Antibiotics Antibiotics. Antiinfectious agents. Antiparasitic agents Area Under Curve Bacteria Biological and medical sciences Biotransformation Blister - chemically induced Blister - metabolism Body fluids Bullous diseases of the skin Cantharidin Chromatography, High Pressure Liquid cSSSIs Dermatology Female Humans Infections Infusions, Intravenous Irritants Kinetics lipoglycopeptides Male Medical sciences Middle Aged Pharmacology Pharmacology. Drug treatments Plasma - chemistry Skin - metabolism Staphylococcus aureus Tandem Mass Spectrometry Teicoplanin - adverse effects Teicoplanin - analogs & derivatives Teicoplanin - blood Teicoplanin - pharmacokinetics |
| Title | Pharmacokinetics of dalbavancin in plasma and skin blister fluid |
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