Tuesday, November 28, 2006
Main Category: Infectious Diseases / Bacteria / Viruses News
Article Date: 26 Nov 2006 - 23:00pm (PST)
A single dose of antibiotics prior to surgery appears to prevent infections occurring at the surgical site as effectively as a 24-hour dosing regimen, and with reduced antibiotic costs, according to an article in the November issue of Archives of Surgery, one of the JAMA/Archives journals. Infections remain an important complication of surgical procedures despite increased knowledge about prevention and technological advances in modern surgery, according to background information in the article.
Prophylactic antibiotics--preventive antibiotics given before surgery--have been shown to decrease the occurrence of infection at the site of the surgery. However, due to rising health care costs and concerns about antimicrobial resistance, hospitals have been under pressure to use fewer antibiotics. Most guidelines for the use of prophylactic antibiotics recommend using only one dose prior to surgery; however, surgeons might not comply with this recommendation, sometimes giving patients more than one dose or using broad-spectrum (targeting many types of bacteria) rather than the recommended narrow-spectrum drugs. Silvia Nunes Szente Fonseca, M.D., M.P.H., Hospital Sao Francisco, Ribeirao Preto, Sao Paolo, Brazil, and colleagues studied infection rates before and after the implementation of a one-dose prophylactic antibiotic protocol at a local hospital. "We previously described the successful implementation of an antibiotic prophylaxis program in our hospital, discontinuing prophylactic antibiotic usage after 24 hours and correcting the timing of the first dosage," the authors write. "We decided to reduce all antibiotic prophylaxis to one dose because this measure could safely promote savings for our institution."
Under the new protocol, for most procedures, patients are given one 1-gram dose of the antibiotic cephazolin at the same time anesthesia is administered. The protocol was approved by surgeons prior to implementation; education was provided to surgical and medical staff. To assess the effectiveness of this approach, the researchers examined infection rates and costs for 6,140 consecutive patients who had surgery between February 2002 and October 2002 and 6,159 consecutive patients who had surgery between December 2002 and August 2003, following the implementation of the one-dose protocol.
The correct protocol was followed in 6,123 (99 percent) of the surgeries performed after the new guidelines were implemented. Surgical site infections occurred in 127 (2 percent) of surgeries performed under the 24-hour protocol and 133 (2.1 percent) performed under the one-dose protocol. The number of vials of cephazolin purchased decreased from 1,259 in the first time period to 467 in the second, a 63 percent decline that represented a monthly cost savings of $1,980 for this drug alone. The cooperation and encouragement of hospital administration and clinical staff, as well as educational efforts, contributed to the success of the new protocol, the authors write. "We were able to demonstrate that one-dose prophylaxis is feasible," they conclude. "In this era of restricted hospital budgets and increased bacterial resistance, one-dose prophylaxis may provide a way to improve performance by lowering costs." ### (Arch Surg. 2006;141:1109-1113.)
This study was supported by the Waldemar Barnsley Pessoa Foundation and Maternidade Sinha Junqueira Foundation.
Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc. Contact: Silvia Nunes Szente Fonseca
JAMA and Archives Journals
Tuesday, November 07, 2006
1: Dermatol Online J. 2006 May 30;12(4):6.
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]
* * * * * *
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, firstname.lastname@example.org
To review the pharmacology, microbiology, chemistry, in vitro susceptibility, pharmacokinetics, clinical efficacy, safety, tolerability, dosage, and administration of dalbavancin, a new semisynthetic lipoglycopeptide.
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.
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.
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.
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]