P846 ATLAS 2: a double-blind, randomised, active controlled, multinational Phase 3 study comparing telavancin with vancomycin for the treatment of patients with complicated skin and skin structure infections

Corey, G. Ralph; Stryjewski, Martín E.; Fowler, VG; Teglia, Osvaldo; Hopkins, Alan R.; Kitt, M.M.; Barriere, SL

doi:10.1016/s0924-8579(07)70687-8

Cited by 3 publications

(7 citation statements)

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“…The ATLAS II study was an identical study in which 1012 patients received study drug, 325 (32.1%) of whom had MRSA isolated at baseline. 52 In the clinically evaluable population, 88.7% of patients receiving telavancin and 87.6% of patients receiving vancomycin achieved clinical cure. Among those with MRSA, 93.2% of those receiving telavancin and 87.1% of those receiving vancomycin achieved clinical cure.…”

Section: Phases II and Iii Trialsmentioning

confidence: 99%

“…A pair of phase III trials of telavancin for complicated skin and skin structure infectionsthe Assessment of Telavancin in Skin and Skin Structure Infections (ATLAS) I and II studieswere completed in May 2006. 51,52 These were large prospective, double-blind, randomized clinical evaluations of patients with complicated skin and skin structure infections, including a large number of patients infected with MRSA. In ATLAS I and II, patients aged 18 years or older whose infections were caused by a suspected or confirmed gram-positive organism were randomly assigned to receive either telavancin 10 mg/kg once/day or vancomycin 1 g every 12 hours for 7-14 days.…”

Section: Phases II and Iii Trialsmentioning

confidence: 99%

“…Telavancin is administered intravenously once/day. In clinical trials, it has been studied at doses of 7.5 and 10 mg/kg for complicated skin and skin structure infections, 37,38,51,52 and recently an approvable letter was received from the FDA for this indication. It has also been studied safely up to 15 mg/kg in healthy volunteers.…”

Section: Dosage and Administrationmentioning

confidence: 99%

“…In the ATLAS studies, serious adverse events leading to discontinuation or death were reported to be similar for patients receiving telavancin and vancomycin. 51,52 The most commonly reported adverse event with telavancin versus vancomycin was altered or metallic taste (33% vs 7%) followed by nausea (27% vs 15%). Increases in serum creatinine level were more frequent in the telavancin group (7.4%) compared with the vancomycin group (3%); however, these resolved during follow-up in all but one patient from each group.…”

Section: Safetymentioning

confidence: 99%

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Telavancin: An Antimicrobial with a Multifunctional Mechanism of Action for the Treatment of Serious Gram‐Positive Infections

Leonard

Rybak

2008

Pharmacotherapy

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Telavancin is a once-daily lipoglycopeptide antibiotic structurally derived from vancomycin. It has broad-spectrum activity against gram-positive bacteria, including strains with reduced susceptibility to vancomycin. Telavancin's multifunctional mechanism of action, including inhibition of peptidoglycan synthesis and disruption of membrane potential, account for this enhanced activity as well as rapid bactericidal properties. In vitro activity has been demonstrated against a wide range of gram-positive pathogens such as multidrug-resistant Streptococcus pneumoniae, as well as methicillin-resistant, glycopeptide-intermediate, and vancomycin-resistant Staphylococcus aureus. The agent also displays activity against many gram-positive anaerobic organisms. Predictable linear pharmacokinetics have been demonstrated over a wide range of doses, with the most common adverse effects being taste disturbance and nausea. Clinical experience with telavancin in phase II and III studies for complicated skin and skin structure infections has shown it to have similar efficacy and tolerability compared with vancomycin and antistaphylococcal penicillins, and recently telavancin received an approvable letter from the United States Food and Drug Administration for this indication. Telavancin appears to be a promising agent for the treatment of serious infections caused by gram-positive pathogens, including drug-resistant pathogens. Further clinical experience will clarify its role in therapy.

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Section: Phases II and Iii Trialsmentioning

confidence: 99%

Section: Phases II and Iii Trialsmentioning

confidence: 99%

Section: Dosage and Administrationmentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

See 2 more Smart Citations

Telavancin: An Antimicrobial with a Multifunctional Mechanism of Action for the Treatment of Serious Gram‐Positive Infections

Leonard

Rybak

2008

Pharmacotherapy

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“…Except for mild gastrointestinal upset and foamy urine in the telavancin group and pruritus in the vancomycin group, the adverse events were similar. This work demonstrated that telavancin given once daily is at least as effective as vancomycin for the treatment of patients with complicated skin and skin-structure infections, including those infected with MRSA (38,39). Besides FDA approved indications, some new case reports have provided limited experiences in other situations caused by Gram-positive pathogens.…”

mentioning

confidence: 97%

Lipoglycopeptide Antibiotics: Reliable Fighters Against Gram-Positive Pathogens

Bagheri¹,

Sohrabi

Salarian

et al. 2018

Arch Clin Infect Dis

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Multi-drug resistant (MDR) strains of staphylococci are usually difficult to treat. Vancomycin has had a time-honored niche in treating MDR Staphylococcus strains; however, during recent years, many clinical failures have been reported worldwide. Since 2014, new semisynthetic lipoglycopeptides antibiotics have been introduced to combat methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-intermediate Staphylococcus aureus (VISA), vancomycin-resistant Staphylococcus aureus (VRSA), and vancomycin-resistant enterococci (VRE). They include dalbavancin, oritavancin, and telavancin. These semisynthetic lipoglycopeptides have a considerable efficacy against MDR Staphylococcus strains. Due to the presence of a lipid side chain, the half-life is prolonged and enables them to anchor the cell membrane of a pathogen. Lipoglycopeptides display a greater potency and more consistent activity against all species of staphylococci than vancomycin. Among them, oritavancin is active against MRSA, VISA, and VRSA. However, dalbavancin and telavancin have activities against MRSA and VISA. Dalbavancin is used once weekly, telavancin is used daily, and oritavancin is usually administered one dose per treatment. Compared to vancomycin, these semisynthetic lipoglycopeptides have longer half-lives with a lower minimum inhibitory concentration (MIC) and fast bactericidal activities. In addition, lipoglycopeptides have concentration-dependent effects in vivo and in vitro. In the present paper, we review the structure, mechanism of action, microbiology, indications, safety, and important interactions of dalbavancin, oritavancin, and telavancin.

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Systematic Review and Meta-Analysis of the Efficacy and Safety of Telavancin for Treatment of Infectious Disease: Are We Clearer?

Chuan

Zhang

et al. 2016

Front. Pharmacol.

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Objective: Telavancin is approved to treat complicated skin and skin structure infections, hospital-acquired, and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus. A previous meta-analysis of randomized controlled trials suggested that it might be an alternative to vancomycin in cases of difficult-to-treat meticillin-resistant S. aureus infections. We did a meta-analysis including one new trial to access the efficacy and safety of telavancin.Methods: We searched PubMed, Cochrane Central Register of Controlled Trials, EMBASE and ClinicalTrials.gov up to December 30, 2015 to identify randomized controlled trials that assessed the clinical efficacy, eradication efficiency, adverse events and laboratory abnormalities of telavancin vs. other antibiotic agents for bacterial infection. Meta-analysis was performed using Review Manager 5.3.0.Results: Five studies (3790 participants) were included in the meta-analysis. There was no significant difference in treatment success with telavancin than with control antibiotic agents. The pooled pathogen eradication for the telavancin group was numerically higher than that for the control groups, but there was no significant difference. While all-cause mortalities and serious adverse events were comparable between telavancin and control antibiotic agents, adverse event-related withdrawals (OR 1.47, 95% CI 1.13–1.91) were higher in telavancin group. The total number adverse events were more in the telavancin group than in the control groups, especially in the digestive system (OR 1.57, 95% CI 1.37–1.79), nervous system (OR 2.14, 95% CI 1.86–2.47) and urogenital system (OR 2.54, 95% CI 1.99–3.25). Serum creatinine increase (OR 2.25, 95% Cl 1.78–2.85) and hypokalemia (OR 1.74, 95% CI 1.19–2.53) occurred more frequently in telavancin group compared to control groups.Conclusion: Telavancin may be as effective as but no better than the comparison therapy for S. aureus infection. However, because of the high risk of adverse event-related withdrawals and potential nephrotoxicity, prudence with the clinical use of telavancin in infections is required.

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P846 ATLAS 2: a double-blind, randomised, active controlled, multinational Phase 3 study comparing telavancin with vancomycin for the treatment of patients with complicated skin and skin structure infections

Cited by 3 publications

References 0 publications

Telavancin: An Antimicrobial with a Multifunctional Mechanism of Action for the Treatment of Serious Gram‐Positive Infections

Telavancin: An Antimicrobial with a Multifunctional Mechanism of Action for the Treatment of Serious Gram‐Positive Infections

Lipoglycopeptide Antibiotics: Reliable Fighters Against Gram-Positive Pathogens

Systematic Review and Meta-Analysis of the Efficacy and Safety of Telavancin for Treatment of Infectious Disease: Are We Clearer?

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