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: December 27, 2013
Last verified: December 2013

September 8, 2011
December 27, 2013
July 2011
November 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01431339 on ClinicalTrials.gov Archive Site
  • 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
  • >= 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: Follow-Up Visit (day 28) ] [ Designated as safety issue: No ]
    Compare the clinical efficacy at the short term follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs temperature and receipt of other therapy
  • 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.
Not Provided
Not Provided
 
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Abscess
  • Wound Infection
  • Surgical Site Infection
  • Cellulitis
  • Drug: IV Dalbavancin
    IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
  • Drug: Vancomycin/Linezolid
    IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
  • Active Comparator: Vancomycin with possible switch to oral linezolid
    Intervention: Drug: Vancomycin/Linezolid
  • Experimental: Dalbavancin
    Intervention: Drug: IV Dalbavancin
Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne MW. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med. 2014 Jun 5;370(23):2169-79. doi: 10.1056/NEJMoa1310480.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
739
December 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Lithuania,   United States,   Korea, Republic of,   Ukraine,   Taiwan,   South Africa,   Slovakia,   Russian Federation,   Romania,   Estonia,   Latvia,   Hungary,   Israel,   Bulgaria
 
NCT01431339
DUR001-302
No
Durata Therapeutics, Inc.
Durata Therapeutics, Inc.
Not Provided
Study Director: Michael Dunne, MD Durata Therapeutics, Inc.
Durata Therapeutics, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP