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:
NCT01339091
First received: April 18, 2011
Last updated: December 26, 2013
Last verified: December 2013
  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 proven gram-positive bacterial skin or skin structure infection.


Condition Intervention Phase
Abscess
Wound Infection
Surgical Site Infection
Cellulitis
Drug: 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 Regiment (Vancomycin and Linezolid) for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Early Clinical Efficacy [ Time Frame: 48-72 hours after the initiation of study 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:
  • >= 20% Reduction in Lesion Area [ Time Frame: 48-72 hours after the initiation of study 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

  • 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 non-study antibiotics

  • Clinical Status [ Time Frame: Follow-Up Visit (day 28) ] [ Designated as safety issue: No ]
    Compare the clinical efficacy at the day 28 follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics


Enrollment: 573
Study Start Date: March 2011
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dalbavancin Drug: Dalbavancin
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
Active Comparator: Vancomycin with possible switch to oral linezolid Drug: Vancomycin / Linezolid
IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339091

  Show 92 Study Locations
Sponsors and Collaborators
Durata Therapeutics, Inc.
Investigators
Study Director: Michael Dunne, MD Durata Therapeutics, Inc.
  More Information

No publications provided by Durata Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Durata Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01339091     History of Changes
Other Study ID Numbers: DUR001-301
Study First Received: April 18, 2011
Results First Received: November 7, 2013
Last Updated: December 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dalbavancin
Abscess
Cellulitis
Wound Infection
Suppuration
Infection
Inflammation
Pathologic Processes
Skin Diseases, Infectious
Connective Tissue Diseases
Wounds and Injuries
Vancomycin
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 August 28, 2014