Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections



Status:Completed
Conditions:Hospital, Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery, Other
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:July 2011
End Date:October 2012
Contact:Milan Kovacevic, MD, PhD
Email:mkovacevic@duratatherapeutics.com
Phone:973-993-4870

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A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Dalbavancin to a Comparator Regimen (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections


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 proved gram-positive bacterial
skin or skin structure infections.


Inclusion Criteria:

1. Male or female patients 18 - 85 years of age.

2. Signed and dated informed consent document.

3. Major abscess, surgical site infection, traumatic wound infection or cellulitis
suspected or confirmed to be caused by Gram-positive bacteria.

4. At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic
sign of infection.

5. Requires a minimum of 3 days of IV therapy.

6. Patient willing and able to comply with study procedures.

Exclusion Criteria:

Patients presenting with any of the following:

1. A contra-indication to any required study drug.

2. Pregnant or nursing females.

3. Sustained shock.

4. Participation in another study of an investigational drug or device within 30 days.

5. Receipt of a systemically or topically administered antibiotic within 14 days prior
to randomization, except receipt of a single dose of a short-acting antibacterial
drug 3 or more days prior to randomization.

6. Infection due to a dalbavancin or vancomycin-resistant organism.

7. Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic
arthritis, osteomyelitis, and/or endovascular infection.

8. Exclusively gram-negative bacterial or a fungal ABSSSI.

9. Venous catheter infection.

10. Infection of a diabetic foot ulcer or a decubitus ulcer.

11. Device-related infections.

12. Gram-negative bacteremia.

13. Infected burns.

14. Infected limb with critical ischemia.

15. Superficial/simple skin and skin structure infections.

16. Concomitant condition requiring non-study antibacterial therapy.

17. ABSSSI requiring therapy for longer than 14 days.

18. Adjunctive therapy with hyperbaric oxygen.

19. More than 2 surgical interventions for ABSSSI anticipated.

20. Chronic inflammatory condition precluding assessment of clinical response.

21. Absolute neutrophil count < 500 cells/mm3.

22. Human immunodeficiency virus (HIV) infection with a CD4 cell count < 200 cells/mm3.

23. Recent bone marrow transplant, > 20 mg prednisolone per day (or equivalent) or
receiving immunosuppressant drugs after organ transplantation.

24. Regular, chronic antipyretic use in patients unable to modify during the first three
days of study drug therapy.

25. Life expectancy less than 3 months.

26. Conditions that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results.

27. Prior participation in the study.
We found this trial at
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Columbus, Ohio 43215
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Anaheim, California 92804
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Chicago, Illinois 60637
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Columbus, Georgia 31904
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Houston, Texas 77002
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Madison, Wisconsin 53717
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Miami, Florida 33144
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Moline, Illinois 61265
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Montgomery, Alabama 36106
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