Telavancin versus standard therapy for treatment of complicated skin and skin structure infections caused by gram-positive bacteria: FAST 2 study

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dc.contributor.authorStryjewski M.E.
dc.contributor.authorChu V.H.
dc.contributor.authorO'Riordan W.D.
dc.contributor.authorWarren B.L.
dc.contributor.authorDunbar L.M.
dc.contributor.authorYoung D.M.
dc.contributor.authorVallee M.
dc.contributor.authorFowler Jr. V.G.
dc.contributor.authorMorganroth J.
dc.contributor.authorBarriere S.L.
dc.contributor.authorKitt M.M.
dc.contributor.authorCorey G.R.
dc.date.accessioned2011-05-15T16:15:33Z
dc.date.available2011-05-15T16:15:33Z
dc.date.issued2006
dc.description.abstractTelavancin is a bactericidal lipoglycopeptide with a multifunctional mechanism of action. We conducted a randomized, double blind, active-control phase II trial. Patients S18 years of age with complicated skin and skin structure infections caused by suspected or confirmed gram-positive organisms were randomized to receive either telavancin at 10 mg/kg intravenously every 24 h (q24h) or standard therapy (antistaphylococcal penicillin at 2 g q6h or vancomycin at 1g q12h). A total of 195 patients were randomized and received at least one dose of study medication. Clinical success rates were similar in all analysis populations at test of cure. In microbiologically evaluable patients with Staphylococcus aureus at baseline (n = 91), 96% of the telavancin group and 90% of the standard-therapy group were cured. Among patients with methicillin-resistant S. aureus (MRSA) at baseline (n = 45), clinical cure rates were also 96% for telavancin and 90% for standard therapy. Microbiologic eradication in patients with S. aureus infection was better with telavancin compared to standard therapy (92% versus 78%, P = 0.07) and significantly better in patients with MRSA (92% versus 68%; P = 0.04). Therapy was discontinued for an adverse event (AE) in 6% and 3% of the patients receiving telavancin and standard therapy, respectively. Except for two cases of rash in the telavancin group, these AEs were similar in type and severity in the two groups. The overall incidences and severities of AEs and laboratory abnormalities were similar between the two groups. These data support the ongoing studies assessing the efficacy and safety of telavancin in the treatment of serious gram-positive infections, particularly involving MRSA. Copyright © 2006, American Society for Microbiology. All Rights Reserved.
dc.description.versionArticle
dc.identifier.citationAntimicrobial Agents and Chemotherapy
dc.identifier.citation50
dc.identifier.citation3
dc.identifier.issn00664804
dc.identifier.other10.1128/AAC.50.3.862-867.2006
dc.identifier.urihttp://hdl.handle.net/10019.1/13388
dc.subjectaztreonam
dc.subjectbeta lactam antibiotic
dc.subjectcloxacillin
dc.subjectmetronidazole
dc.subjectnafcillin
dc.subjectoxacillin
dc.subjectpenicillin derivative
dc.subjectquinoline derived antiinfective agent
dc.subjecttelavancin
dc.subjectvancomycin
dc.subjectadult
dc.subjectanemia
dc.subjectantibiotic resistance
dc.subjectarticle
dc.subjectatelectasis
dc.subjectburn infection
dc.subjectcellulitis
dc.subjectchill
dc.subjectclinical trial
dc.subjectconstipation
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdiarrhea
dc.subjectdisseminated intravascular clotting
dc.subjectdouble blind procedure
dc.subjectdrug blood level
dc.subjectdrug efficacy
dc.subjectdrug mechanism
dc.subjectdrug safety
dc.subjecteosinophilia
dc.subjecteradication therapy
dc.subjectfemale
dc.subjectgastrointestinal hemorrhage
dc.subjectGram positive bacterium
dc.subjectheadache
dc.subjectheart atrium fibrillation
dc.subjecthuman
dc.subjecthypokalemia
dc.subjecthypomagnesemia
dc.subjecthypotension
dc.subjectinsomnia
dc.subjectkidney failure
dc.subjectleukopenia
dc.subjectliver dysfunction
dc.subjectliver failure
dc.subjectlobar pneumonia
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmethicillin resistant Staphylococcus aureus
dc.subjectmicroalbuminuria
dc.subjectmulticenter study
dc.subjectmultiple organ failure
dc.subjectmyositis
dc.subjectnausea
dc.subjectphase 2 clinical trial
dc.subjectpriority journal
dc.subjectpruritus
dc.subjectQT prolongation
dc.subjectrandomized controlled trial
dc.subjectrash
dc.subjectrespiratory failure
dc.subjectskin abscess
dc.subjectskin infection
dc.subjectskin ulcer
dc.subjectStaphylococcus aureus
dc.subjectStaphylococcus infection
dc.subjectsuicidal ideation
dc.subjecttaste disorder
dc.subjectthrombocytopenia
dc.subjecttreatment outcome
dc.subjectvomiting
dc.subjectwound infection
dc.subjectAdult
dc.subjectAminoglycosides
dc.subjectAnti-Bacterial Agents
dc.subjectDouble-Blind Method
dc.subjectFemale
dc.subjectGram-Positive Bacteria
dc.subjectGram-Positive Bacterial Infections
dc.subjectHumans
dc.subjectMale
dc.subjectPenicillins
dc.subjectSkin Diseases, Bacterial
dc.subjectTreatment Outcome
dc.subjectVancomycin
dc.titleTelavancin versus standard therapy for treatment of complicated skin and skin structure infections caused by gram-positive bacteria: FAST 2 study
dc.typeArticle
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