1: Dermatol Online J. 2006 May 30;12(4):6.
Scheinfeld N.
Department of Dermatology, St Lukes Roosevelt Hospital, New York.
Most complicated skin and skin structure infections (cSSSI) are caused by Staphylococcus aurens (SA) and streptococcus (SC). More and more isolates of SA and SC are resistant to methicillin (MRSA) and there are concerns that SA will become resistant to vancomycin (VRSA), the current standard of treatment. Dalbavancin (BI397) is a novel semisynthetic lipoglycopeptide that was designed to improve uon the natural glycopeptides currently available, vancomycin and teicoplanin. Phase-III clinical trials comprising more than 1,500 patients evaluating once-weekly dalbavancin in skin and soft tissue infections (SSTIs) associated with Gram-positive bacteria met the primary endpoint of non-inferiority in patients whose clinical response was evaluated at 2 weeks following therapy when compared to linezolid, cefazolin, or vancomycin, the three most widely administered standard-of-care agents for SSTIs. The side effect profile of dalbavancin is mild, with headache and pyrexia being the most adverse effects.
Once-a-week dosing with dalbavancin may obviate the need for the continued presence of IV lines in some patients, which could translate into fewer local infections and blood stream infections and which could facilitate transfer of the patients to skilled nursing facilities. Unlike other new antibiotics, such as oritavancin and tigecycline, dalbavancin is not active against vancomycin-resistant enterococcus or VRSA. Its approval by the FDA is expected soon. The extent to which dalbavancin will supplant vancomycin and whether it will be preferred other newer agents such as linezolid.
PMID: 17083861 [PubMed - in process]
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Dalbavancin: a new option for the treatment of gram-positive infections.
1: Ann Pharmacother. 2006 Mar;40(3):449-60. Epub 2006 Feb 28
NEW DRUG DEVELOPMENTS
Dalbavancin: A New Option for the Treatment of Gram-Positive Infections Shu-Wen Lin, MS PharmD
at time of writing, Specialty Resident in Infectious Diseases, Department of Pharmacy Services, University of Michigan Health System; Clinical Instructor, Department of Clinical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI; now, Clinical Pharmacist, Infectious Diseases, Department of Pharmacy Services, Hahnemann University Hospital, Philadelphia, PA
Peggy L Carver, PharmD
Clinical Pharmacist in Infectious Diseases, Department of Pharmacy Services, University of Michigan Health System; Associate Professor, Department of Clinical Sciences, College of Pharmacy, University of Michigan
Daryl D DePestel, PharmD
Clinical Pharmacist in Infectious Diseases, Department of Pharmacy Services, University of Michigan Health System; Clinical Assistant Professor, Department of Clinical Sciences, College of Pharmacy, University of Michigan
Reprints: Dr. DePestel, Departments of Pharmacy Services and Clinical Sciences, University of Michigan Health System, UH B2D 301/0008, 1500 E. Medical Center Dr., Ann Arbor, MI 48109-0008, fax 734/936-7027, daryldd@umich.edu
OBJECTIVE:
To review the pharmacology, microbiology, chemistry, in vitro susceptibility, pharmacokinetics, clinical efficacy, safety, tolerability, dosage, and administration of dalbavancin, a new semisynthetic lipoglycopeptide.
DATA SOURCES:
A MEDLINE search, restricted to the English language, was conducted from 1966 through January 2006. Supplementary sources included program abstracts from the Interscience Conference on Antimicrobial Agents and Chemotherapy, American Society of Microbiology, and the Infectious Diseases Society of America from 2000 to 2005 and information available from the manufacturer's Web site.
STUDY SELECTION AND DATA EXTRACTION:
In vitro and preclinical studies, as well as Phase I, II, and III clinical trials, were evaluated to summarize the microbiology, pharmacology, clinical efficacy, and safety of dalbavancin. All published trials and abstracts citing dalbavancin were selected.
DATA SYNTHESIS:
Dalbavancin, a novel lipoglycopeptide, has a mechanism of action similar to that of other glycopeptides. It has in vitro activity against a variety of gram-positive organisms, but no activity against gram-negative or vancomycin-resistant enterococci that possess VanA gene. Due to its prolonged half-life (6-10 days), dalbavancin can be administered intravenously once weekly. In Phase II and III clinical trials, dalbavancin was effective and well tolerated for the treatment of skin and soft-tissue infections, catheter-related bloodstream infections, and skin and skin-structure infections. To date, adverse events are mild and limited; the most common include pyrexia, headache, nausea, oral candidiasis, diarrhea, and constipation.
CONCLUSIONS:
Dalbavancin appears to be a promising antimicrobial agent for the treatment of gram-positive infections. A new drug application was filed with the Food and Drug Administration (FDA) in December 2004. The FDA issued an approvable letter in 2005 for dalbavancin. If approved, dalbavancin is expected to be launched in the first quarter of 2006.
Key Words: BI397, dalbavancin, glycopeptide, gram-positive
Published Online, February 28, 2006. DOI 10.1345/aph.1G158
* * * * * *Dalbavancin activity against selected populations of antimicrobial-resistant Gram-positive pathogens.
Diagn Microbiol Infect Dis. 2005 Dec;53(4):307-10.
Streit JM,
Sader HS,
Fritsche TR,
Jones RN.
The JONES Group/JMI Laboratories, North Liberty, IA 52317, USA.
Dalbavancin, a dimethylaminepropyl amide derivative of the lipoglycopeptide A40926, was tested against 375 antimicrobial-resistant Gram-positive pathogens collected worldwide during 2001-2003. The isolates were tested by reference and Clinical Laboratory Standards Institute broth microdilution susceptibility methods, and dalbavancin was compared with over 20 other antimicrobials. Vancomycin resistance determinants among enterococci were identified using PCR primer sets for vanA and vanB. Dalbavancin was generally more potent than vancomycin or teicoplanin. Dalbavancin was highly active against penicillin- and ceftriaxone-resistant Streptococcus pneumoniae strains (MIC(90), < or =" 0.016">
PMID: 15922534 [PubMed - indexed for MEDLINE]
