Program Schedule

266
Dalbavancin versus Vancomycin for the treatment of acute bacterial skin and skin structure infections (ABSSSI): a subanalysis from the DISCOVER studies

Session: Poster Abstract Session: Antimicrobial Resistance: Novel Agents and Approaches to Gram-positive Infections
Thursday, October 9, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Background:

To compare efficacy and safety outcomes for patients enrolled in 2 prospective phase 3 ABSSSI clinical trials of dalbavancin (DAL) who received study drug only IV, with no switch to oral therapy, for a total duration of 10-14 days.

Methods:

Both trials were double-blind, double dummy, randomized trials in which patients with ABSSSI were randomized to receive DAL 1g IV on Day 1 and 500 mg IV on Day 8 or Vancomycin (VAN) 1g (or 15mg/kg) IV every 12 hours (q12h) for at least 3 days with an option to switch to oral linezolid (L) 600 mg q12h to complete 10-14 days of therapy. In a pooled analysis, we identified patients who received ≥10 days of IV VAN/placebo study drug without being switched to oral therapy (oral placebo for patients in the DAL group and oral L in the VAN/L group). Efficacy and safety outcomes for this subset of patients were evaluated.

Results:

61/652 (9.4%) patients randomized to DAL completed ≥10 days of IV placebo compared to 54/651 (8.3%) of patients randomized to VAN/L who received ≥10 days of IV VAN.

Table 1. Clinical Success at EOT in patients who did not switch to oral therapy

Clinical Success at EOT

DAL
n/N (%)

VAN
n/N (%)

CE Population

39/56 (69.6)

34/49 (69.4)

ITT Population

42/61 (68.9)

36/54 (66.7)

Table 2: Summary of total adverse events

Number of Patients Who Experienced at Least One of

DAL

N=61
n (%)

VAN

N= 54
n (%)

Treatment-Emergent  adverse event (TEAE)

18 (29.5)

25 (46.3)

Drug-Related TEAE

3 (4.9)

3 (5.6)

TE-Serious AE (TE-SAE)

1 (1.6)

7 (13.0)

Drug-Related TE-SAE

0

0

TE-SAE Leading to Death

0

1 (1.9)

TEAE Leading to Premature Discontinuation of Study Drug

1 (1.6)

0

TE-SAE Leading to Premature Study Drug Discontinuation

0

0

Table 3: Nephrotoxicity* on therapy

 

DAL
n/N(%)

VAN
n/N(%)

P-Value

ITT Population

21 / 637 (3.3)

31 / 638 (4.9)

0.16

DAL versus IV VAN only

21/637 (3.3)

5/54 (9.3)

0.06

Patients who received IV treatment (DAL + IV placebo or VAN) only

1 / 58 (1.7)

5 / 54 (9.3)

0.21

*nephrotoxicity defined as a 50% increase from baseline serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dL

Conclusion: Patients with ABSSSI treated with DAL had similar clinical success rates at EOT compared to those treated with IV VAN alone. Compared to patients receiving DAL, patients who received IV VAN for ≥10 days had a tendency towards more TEAEs and more nephrotoxicity.

Sailaja Puttagunta, MD1, Helen Boucher, MD, FIDSA2, George Talbot, MD3, Mark Wilcox, MD4 and Michael Dunne, MD1, (1)Durata Therapeutics, Branford, CT, (2)Tufts New Engl Med Ctr, Boston, MA, (3)Talbot Advisors LLC, Anna Maria, FL, (4)Microbiology, Leeds Teaching Hospitals and University of Leeds, Leeds, United Kingdom

Disclosures:

S. Puttagunta, Durata Therapeutics: Employee and Shareholder, Salary

H. Boucher, None

G. Talbot, Durata Therapeutics: Consultant, Scientific Advisor and Shareholder, Consulting fee

M. Wilcox, Durata Therapeutics: Scientific Advisor, Consulting fee

M. Dunne, Durata Therapeutics: Employee and Shareholder, Salary

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