Program Schedule

267
Dalbavancin for the treatment of Streptococcal Skin Infections

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:

Streptococci are a known cause of complicated skin and soft tissue infections (cSSTI). Dalbavancin, a lipoglycopeptide antibiotic has been studied in 3 global phase 3 randomized, double-blind, controlled trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and cSSTI.  The objective of this analysis is to evaluate outcomes for patients with streptococcal skin infections enrolled in the 3 global trials.

Methods:

Patients enrolled in the 3 phase 3 ABSSSI/cSSTI trials with baseline cultures positive for streptococcal species were identified. In these trials, dalbavancin, 1 g IV on day 1 followed by 500mg IV on day 8 was compared to either IV vancomycin or IV linezolid with an option to switch to oral linezolid. The MIC distribution of streptococcal isolates and clinical outcomes for patients with streptococcal skin infections were determined.

Results:

The in vitro MIC90 to dalbavancin for each strain of streptococci was ≤0.06 mcg/mL.

Table 1: Distribution of streptococci in 3 phase 3 ABSSSI/cSSTI trials

 

DUR001‑301/302 +
VER001‑9

Dalbavancin

Comparators

n

%

n

%

Baseline Isolates

N=695

N=521

S. pyogenes

  50

  7.2

  46

   8.8

S. agalactiae

  24

  3.5

  22

   4.2

Streptococcus viridans group

17

2.4

10

1.9

S. dysgalactiae

8

1.2

2

0.4

Streptococcus Group C

5

0.7

5

1.0

Streptococcus Group G

10

1.4

7

1.3

Streptococcus anginosus Group

22

3.2

25

4.8

S. anginosus

6

0.9

4

0.8

S. constellatus

15

2.2

16

3.1

S. intermedius

6

0.9

7

1.3

Streptococcus pneumoniae

1

0.1

0

0.0

Other streptococci*

2

0.3

5

1.0

*includes S. bovis, S. gordonii, S. mitis, S. mutans, S. salivarius and other streptococcal species

Table 2: Clinical Success* at EOT by Key Target Pathogen

Baseline Pathogen

Dalbavancin

n/N (%)

Comparator

n/N (%)

S. pyogenes

43/45 (95.6)

37/39 (94.9)

S. agalactiae

19/21 (90.5)

12/14 (85.7)

S. dysgalactiae

8/8 (100)

2/2 (100)

S. anginosus

6/6 (100)

3/3 (100)

S. constellatus

11/11 (100)

14/14 (100)

S. intermedius

4/4 (100)

5/5 (100)

*assessed by investigators; EOT = end of treatment

Conclusion:

Data from the clinical trial program confirm the in vitro activity of dalbavancin against strains of streptococci. Patients with streptococcal skin infections treated with dalbavancin had similar clinical success rates at EOT as those treated with the comparator regimens.

Sailaja Puttagunta, MD and Michael Dunne, MD, Durata Therapeutics, Branford, CT

Disclosures:

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

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

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