Status:
COMPLETED
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Lead Sponsor:
Durata Therapeutics Inc., an affiliate of Allergan plc
Conditions:
Abscess
Wound Infection
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
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 tr...
Eligibility Criteria
Inclusion
- Male or female patients 18 - 85 years of age.
- Signed and dated informed consent document.
- Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria.
- At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection.
- Requires a minimum of 3 days of IV therapy.
- Patient willing and able to comply with study procedures.
Exclusion
- Patients presenting with any of the following:
- A contra-indication to any required study drug.
- Pregnant or nursing females.
- Sustained shock.
- Participation in another study of an investigational drug or device within 30 days.
- 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.
- Infection due to a dalbavancin or vancomycin-resistant organism.
- Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, and/or endovascular infection.
- Exclusively gram-negative bacterial or a fungal ABSSSI.
- Venous catheter infection.
- Infection of a diabetic foot ulcer or a decubitus ulcer.
- Device-related infections.
- Gram-negative bacteremia.
- Infected burns.
- Infected limb with critical ischemia.
- Superficial/simple skin and skin structure infections.
- Concomitant condition requiring non-study antibacterial therapy.
- ABSSSI requiring therapy for longer than 14 days.
- Adjunctive therapy with hyperbaric oxygen.
- More than 2 surgical interventions for ABSSSI anticipated.
- Chronic inflammatory condition precluding assessment of clinical response.
- Absolute neutrophil count \< 500 cells/mm3.
- Human immunodeficiency virus (HIV) infection with a CD4 cell count \< 200 cells/mm3.
- Recent bone marrow transplant, \> 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
- Regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy.
- Life expectancy less than 3 months.
- Conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
- Prior participation in the study.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
739 Patients enrolled
Trial Details
Trial ID
NCT01431339
Start Date
July 1 2011
End Date
December 1 2012
Last Update
February 12 2014
Active Locations (137)
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1
Durata Clinical Site
Montgomery, Alabama, United States, 36106
2
Durata Clinical Site
Anaheim, California, United States, 92804
3
Durata Clinical Site
Buena Park, California, United States, 90620
4
Durata Study Site
Chula Vista, California, United States, 91911