Once-Weekly Dalbavancin versus Daily Conventional Therapy for Skin Infection

Boucher, Helen W.; Wilcox, Mark; Talbot, George H.; Puttagunta, Sailaja; Das, Anita; Dunne, Michael

doi:10.1056/nejmoa1310480

Cited by 380 publications

(346 citation statements)

References 14 publications

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“…Among patients with normal baseline alanine aminotransferase (ALT) levels, more patients were found to have postbaseline ALT elevations greater than three times the upper limit of normal with dalbavancin treatment (0.8%) versus vancomycin-linezolid treatment (0.2%). These elevations were reversible in all patients (16,25). Severe hypersensitivity reactions to dalbavancin have been reported, necessitating caution in patients with an allergy to other glycopeptides, such as vancomycin.…”

Section: Dalbavancinmentioning

confidence: 91%

“…U.S. FDA approval was based on the results of two identically designed phase III noninferiority trials, DISCOVER-1 and DISCOVER-2, of dalbavancin for the treatment of ABSSSI (25). Patients received either a two-dose regimen of dalbavancin (1,000 mg intravenously followed 1 week later by 500 mg intravenously) or vancomycin (1,000 mg or 15 mg/kg of body weight every 12 h) given intravenously, with the option to switch to oral linezolid (600 mg twice daily) after 3 days of treatment.…”

Section: Dalbavancinmentioning

confidence: 99%

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New Gram-Positive Agents: the Next Generation of Oxazolidinones and Lipoglycopeptides

et al. 2016

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Section: Dalbavancinmentioning

confidence: 91%

Section: Dalbavancinmentioning

confidence: 99%

New Gram-Positive Agents: the Next Generation of Oxazolidinones and Lipoglycopeptides

et al. 2016

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“…Dalbavancin is a semi-synthetic lipoglycopeptide that was approved by the FDA in May 2014 for the treatment of acute bacterial skin and skin structure infections caused by Gram-positive organisms 1 . The primary goal of detailing this method in a video format is to provide clear guidance to the clinical laboratory and research scientists for testing and reporting of accurate and reproducible dalbavancin susceptibility results.…”

Section: Introductionmentioning

confidence: 99%

A Reference Broth Microdilution Method for Dalbavancin <em>In Vitro</em> Susceptibility Testing of Bacteria that Grow Aerobically

Koeth¹,

DiFranco-Fisher²,

McCurdy

2015

JoVE

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Antimicrobial susceptibility testing (AST) is performed to assess the in vitro activity of antimicrobial agents against various bacteria. The AST results, which are expressed as minimum inhibitory concentrations (MICs) are used in research for antimicrobial development and monitoring of resistance development and in the clinical setting for antimicrobial therapy guidance. Dalbavancin is a semi-synthetic lipoglycopeptide antimicrobial agent that was approved in May 2014 by the Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections caused by Gram-positive organisms. The advantage of dalbavancin over current anti-staphylococcal therapies is its long half-life, which allows for once-weekly dosing. Dalbavancin has activity against Staphylococcus aureus (including both methicillin-susceptible S. aureus [MSSA] and methicillin-resistant S. aureus [MRSA]), coagulase-negative staphylococci, Streptococcus pneumoniae, Streptococcus anginosus group, β-hemolytic streptococci and vancomycin susceptible enterococci. Similar to other recent lipoglycopeptide agents, optimization of CLSI and ISO broth susceptibility test methods includes the use of dimethyl sulfoxide (DMSO) as a solvent when preparing stock solutions and polysorbate 80 (P80) to alleviate adherence of the agent to plastic. Prior to the clinical studies and during the initial development of dalbavancin, susceptibility studies were not performed with the use of P-80 and MIC results tended to be 2-4 fold higher and similarly higher MIC results were obtained with the agar dilution susceptibility method. Dalbavancin was first included in CLSI broth microdilution methodology tables in 2005 and amended in 2006 to clarify use of DMSO and P-80. The broth microdilution (BMD) procedure shown here is specific to dalbavancin and is in accordance with the CLSI and ISO methods, with step-by-step detail and focus on the critical steps added for clarity.

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“…This interferes with bacterial cell wall synthesis. 1,4 The antibacterial activity of dalbavancin best correlates with the ratio of area under the concentration-time curve (AUC) to MIC for S. aureus. 1 Resistance to dalbavancin was not observed.…”

mentioning

confidence: 99%

Dalbavancin

Cada¹,

Ingram

Baker

2014

Hosp Pharm

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Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line. Monographs can be customized to meet the needs of a facility. A drug class review is now published monthly with The Formulary Monograph Service. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, call The Formulary at 800-322-4349. The October 2014 monograph topics are ortitavancin diphosphate, insulin human inhalation powder, empaglifozin, efinaconazole topical solution, 10%, and tavaborole topical solution, 5%. The DUE/MUE is on oritavancin diphosphate.

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Once-Weekly Dalbavancin versus Daily Conventional Therapy for Skin Infection

Cited by 380 publications

References 14 publications

New Gram-Positive Agents: the Next Generation of Oxazolidinones and Lipoglycopeptides

New Gram-Positive Agents: the Next Generation of Oxazolidinones and Lipoglycopeptides

A Reference Broth Microdilution Method for Dalbavancin <em>In Vitro</em> Susceptibility Testing of Bacteria that Grow Aerobically

Dalbavancin

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