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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Durata Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01431339
First received: September 8, 2011
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Abscess
Wound Infection
Surgical Site Infection
Cellulitis
 Drug: IV Dalbavancin
Drug: Vancomycin/Linezolid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cellulitis
U.S. FDA Resources

Further study details as provided by Durata Therapeutics, Inc.:

Primary Outcome Measures:
  • Early Clinical Efficacy [ Time Frame: After 48-72 hours of therapy ] [ Designated as safety issue: No ]
    Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature


Secondary Outcome Measures:
  • Clinical Status [ Time Frame: End of Treatment Visit (Day 14-15) ] [ Designated as safety issue: No ]
    Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs temperature and receipt of other therapy

  • Per-patient Microbiological Efficacy [ Time Frame: End of Treatment Visit (Day 14-15) and Short Term Follow up (Day 26-30) ] [ Designated as safety issue: No ]
    Compare the per-patient microbiological efficacy of dalbavancin to the comparator regimen

  • Efficacy by Individual Pathogens [ Time Frame: End of Treatment Visit (Day 14-15) and Short Term Follow up Visit (Day 26-30) ] [ Designated as safety issue: No ]
    Compare clinical efficacy by individual pathogens in the two treatment groups

  • Pathogen Eradication Rates for Individual Pathogens [ Time Frame: End of Treatment Visit (Day 14-15) and Short Term Follow-up Visit (Day 26-30) ] [ Designated as safety issue: No ]
    Compare pathogen eradication rates for individual pathogens in the two treatment groups

  • Safety and Tolerability [ Time Frame: Through Long Term Follow-up Visit (Day 70) ] [ Designated as safety issue: Yes ]
    Safety ofdalbavancin and vancomycin assessed according to the incidence of adverse events (AEs), Serious AEs and discontinuations due to AEs.

  • Investigator's assessment of clinical response [ Time Frame: End of Treatment Visit (Day 14-15) ] [ Designated as safety issue: No ]
    Success: Resolution or improvement of all signs and symptoms of the infection without treatment-related discontinuation, death or non-antibacterial intervention for the ABSSSI.


Enrollment: 741
Study Start Date: July 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vancomycin +/- oral linezolid Drug: Vancomycin/Linezolid
IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
Experimental: Dalbavancin Drug: IV Dalbavancin
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431339

  Show 137 Study Locations
Sponsors and Collaborators
Durata Therapeutics, Inc.
Investigators
Study Director: Michael Dunne, MD Durata Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Durata Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01431339     History of Changes
Other Study ID Numbers: DUR001-302
Study First Received: September 8, 2011
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Abscess
Cellulitis
Wound Infection
Suppuration
Infection
Inflammation
Pathologic Processes
Skin Diseases, Infectious
Connective Tissue Diseases
Wounds and Injuries
Vancomycin
 Dalbavancin
Teicoplanin
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013