The document summarizes a randomized, double-blind clinical trial comparing the effectiveness of the antibiotic telavancin to standard therapy for treating complicated skin and soft tissue infections. 167 patients were randomized to receive either telavancin or standard treatments like vancomycin, nafcillin, oxacillin or cloxacillin. The study found no significant differences in cure rates or safety between the two groups, indicating that telavancin is as effective as standard therapies for these types of infections. As a new antibiotic, telavancin could provide an alternative treatment option, particularly for infections caused by methicillin-resistant Staphylococcus aureus.
The document summarizes a randomized, double-blind clinical trial comparing the effectiveness of the antibiotic telavancin to standard therapy for treating complicated skin and soft tissue infections. 167 patients were randomized to receive either telavancin or standard treatments like vancomycin, nafcillin, oxacillin or cloxacillin. The study found no significant differences in cure rates or safety between the two groups, indicating that telavancin is as effective as standard therapies for these types of infections. As a new antibiotic, telavancin could provide an alternative treatment option, particularly for infections caused by methicillin-resistant Staphylococcus aureus.
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The document summarizes a randomized, double-blind clinical trial comparing the effectiveness of the antibiotic telavancin to standard therapy for treating complicated skin and soft tissue infections. 167 patients were randomized to receive either telavancin or standard treatments like vancomycin, nafcillin, oxacillin or cloxacillin. The study found no significant differences in cure rates or safety between the two groups, indicating that telavancin is as effective as standard therapies for these types of infections. As a new antibiotic, telavancin could provide an alternative treatment option, particularly for infections caused by methicillin-resistant Staphylococcus aureus.
Direitos autorais:
Attribution Non-Commercial (BY-NC)
Formatos disponíveis
Baixe no formato DOCX, PDF, TXT ou leia online no Scribd
Journal Club Article Ryan Wiest Quality of the Journal Article
A randomized, double-blind, controlled, multi-center trial.
Components of Primary Literature
Title: Telavancin Versus Standard Therapy for Treatment of Complicated Skin and Soft-Tissue Infections Due to Gram-Positive Bacteria Authors: Stryjewski M, ORiordan D, Lau W, et al., Telavancin is a new lipoglycopeptide that is used against gram-positive bacteria, including MRSA, and other vancomycin resistant bacteria. Telavancin is compared to standard therapy when treating complicated skin and soft-tissue infections. Telavancin was found to be just as effective as standard group. This article was published in the journal of Clinical Infectious Disease. This article was peer reviewed and used as a phase-2 clinical trial study. The study was funded by Theravance which produces Telavancin. Many of the investigators/authors are employees of Theravance. The article took place at two different locations including sites in the United States and Africa. 167 patients were randomized into the telavancin group or standard therapy group (vancomycin, nafcillin, oxacillin or cloxacillin). No statistical difference was found between the two groups, adverse effects were similar between the two groups. There are very few new antibiotic medications under development and there has been a recent increase in MRSA infections both in hospital and community settings. Telavancin is a novel new drug that has been shown to be effective against MRSA and is now being tested against standard therapy to prove to be effective. This is a prospective, randomized, double blind, active-controlled trial. Randomization used interactive voice response systems to stratify patients using a block algorithm. The study used ethical protocol and gave the clinicians the ability to change therapy once susceptibility tests were obtained. Patient/subject selection Any patient that was male or non-pregnant female over 18 years old with a diagnosis of complicated skin and soft-tissue infection caused by a suspected or confirmed by a GP organism. 60 percent of participants were male and 64 percent were white. Average age was 44 years old. Inclusion/exclusion criteria
Article
Overview
Introduction
Overall Study Design
Methodology
Journal Club Article Ryan Wiest
Male or non-pregnant female >18 yo. Disease severity must be complicated SSTI (presence of major abscess requiring surgical drainage, an infected burn, deep extensive cellulitis, or an infected wound or ulcer). Purulent drainage must be present or three of the following: erythema, flucuance, heat and/or lowcalized warmth, pain and/or tenderness to palpitation, swelling and/or induration, fever (>38 degrees). Reasons for exclusion: Patients that had received ABX for > 24 hours within 7 days prior to enrollment (unless the pathogen was resistant or there were clinical signs or failure), or if patient had osteomyelitis, gangrene, necrotizing fasciitis, diabetic foot ulcers, creatinine less than 50, mod-severe liver disease, HIV, prolonged QT interval. Random assignment Treatment regimen 1:1 placement in telavancin or standard treatment. Patients were determined to be cured Control confounding variables Restriction on concomitant therapy 80 percent of telavancin group received prior ABX and 66 percent of standard therapy. Outcome measurements Clinical response, microbiological response, safety and tolerability. Groups stratified into All-treated (received at least 1 dose of study medication): Achieved cure, failure, indeterminate. Further stratified into clinical response, and microbiological response. P values and confidence intervals were 2-sided, and a P value of .05 was considered statistically significant. Barnards unconditional test of superiority was used to evaluate groups. In all-treated population telavancin achieved cure 79% and 80% in standard therapy. In clinically evaluable category 92% of telavancin group achieved cure and 96% of standard therapy group. In microbiologically evaluable population 93% of televancin group achieved cure and 95% of standard therapy group. No significant difference in ADRs between groups. Telavancin was shown to be just as effective in complicated SSTIs when compared with standard therapy. Just because serum concentrations were 364 and 16 times greater than MIC how does this relate to being more potent and hence a better option.
Statistical Analysis
Results
Discussion/Conclusion
Journal Club Article Ryan Wiest
Questionable that no patients in the standard therapy group required a switch from a beta-lactam to vancomycin for treatment of MRSA infections. Duration of treatment in both groups was only 7 days. Strengths vs. weakness: Strengths: Double-blind, randomized study. Weaknesses: Possible conflict of interest and study procedures as seen in the replacement of two patients in the telavancin group. No studies showing vancomycin intermediate or resistant strains. Sample size 167, a little small. Outcome measurements Clearly stated and explained. External validity It can be generalize to most, but studies in more diverse and special populations should be considered in the future. Recommendation for change in practice Telavancin is a great option for complicated SSTIs if vancomycin is not an option or MRSA is suspected.
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