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Bone and Cancer

Clinical Trials

Dalvance (dalbavancin)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved May 2014

Specific Treatments:

acute bacterial skin and skin structure infections

General Information

Dalvance (dalbavancin) is an antibacterial drug.

Dalvance is specifically 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 methicillinĀ­susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae and Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus).

Dalvance is supplied as a lyophilized powder for reconstitution into a solution for intravenous administration. The recommended two-dose regimen of Dalvance is 1000 mg followed one week later by 500 mg. Dalvance should be administered over 30 minutes by intravenous infusion.

Clinical Results

FDA Approval
The FDA approval of Dalvance was based on two randomized, double-blind, double-dummy clinical trials of similar design (Trial 1 and Trial 2). The Intent-to-Treat (ITT) population included 1,312 randomized patients. Patients were treated for two weeks with either a two-dose regimen of intravenous Dalvance (1000 mg followed one week later by 500 mg) or intravenous vancomycin (1000 mg or 15 mg/kg every 12 hours, with the option to switch to oral linezolid after 3 days). Dalvance-treated patients with creatinine clearance of less than 30 mL/min received 750 mg followed one week later by 375 mg. The primary endpoint of these two ABSSSI trials was the clinical response rate where responders were defined as patients who had no increase from baseline in lesion area 48 to 72 hours after initiation of therapy, and had a temperature consistently at or below 37.6Ā° C upon repeated measurement. The percentage of responders is as follows: Trial 1: Dalvance: 83.3% and Vancomycin/Linezolid: 81.8%; Trial 2: Dalvance: 76.8% and Vancomycin/Linezolid: 78.3%.

Side Effects

Adverse effects associated with the use of Dalvance may include, but are not limited to, the following:

  • nausea
  • headache
  • diarrhea

Mechanism of Action

Dalvance (Dalbavancin), a semisynthetic lipoglycopeptide, interferes with cell wall synthesis by binding to the D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, thus preventing cross-linking. Dalbavancin is bactericidal in vitro against Staphylococcus aureus and Streptococcus pyogenes at concentrations similar to those sustained throughout treatment in humans treated according to the recommended dosage regimen.

Additional Information

For additional information regarding Dalvance or ABSSSI, please visit the Dalvance web page.

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