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Dalvance (Dalbavancin Hydrochloride) - Summary

 
 



DALVANCE SUMMARY

DALVANCE (dalbavancin) for injection is a lipoglycopeptide synthesized from a fermentation product of Nonomuraea species.

Acute Bacterial Skin and Skin Structure Infections

DALVANCEĀ™ (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae and Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) .

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.


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NEWS HIGHLIGHTS

Published Studies Related to Dalvance (Dalbavancin)

Once-weekly dalbavancin versus daily conventional therapy for skin infection. [2014]
and skin-structure infection... CONCLUSIONS: Once-weekly intravenous dalbavancin was not inferior to twice-daily

Dalbavancin. [2008]
Dalbavancin is a semisynthetic glycopeptide antibacterial agent that is active against Gram-positive bacteria associated with complicated skin and skin structure infections (cSSSIs). It is administered as a two-dose regimen intravenously infused over 30 minutes once weekly... Dalbavancin was generally well tolerated by adult patients with cSSSIs, with most adverse events being of mild or moderate severity.

Dalbavancin: a review for dermatologists. [2006]
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...

Randomized, double-blind comparison of once-weekly dalbavancin versus twice-daily linezolid therapy for the treatment of complicated skin and skin structure infections. [2005]
phase 2 study... CONCLUSIONS: Two doses of dalbavancin (1000 mg given on day 1 followed by 500 mg

Tolerability, pharmacokinetics, and serum bactericidal activity of intravenous dalbavancin in healthy volunteers. [2004]
Fifty-two healthy adult male and female volunteers were enrolled in this double-blind study to determine the maximum tolerated dose, characterize the pharmacokinetics, and obtain serum bactericidal activity (SBA) data for intravenous dalbavancin. Subjects were assigned to single- or multiple-dose groups and randomized to receive dalbavancin or placebo intravenously over 30 min...

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Clinical Trials Related to Dalvance (Dalbavancin)

Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections [Completed]
To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in patients with known or suspected Gram-positive abSSSI (acute bacterial skin and skin

structure infections) at 48 - 72 hours after initiation of treatment.

A P3 Comparator Trial in Community Acquired Bacterial Pneumonia [Not yet recruiting]
This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia.

A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years. [Completed]
A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.

Phase 3, Multicenter, Doubleblind, Rand Dalbavancin vs Comparator in Ped Acute Hematogenous Osteomyelitis [Not yet recruiting]

Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections [Completed]
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial skin or skin structure infection.

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Page last updated: 2015-08-10

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