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

Completed · Phase 3

Conditions studied: Abscess, Wound Infection, Surgical Site Infection, Cellulitis

In brief

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.

Key facts

Study ID

NCT01431339

Run by

Durata Therapeutics Inc., an affiliate of Allergan plc

People needed

739

Starts

2011-07-01

Expected to finish

2012-12-01

Last updated by the study team

2014-02-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Durata Clinical Site — Anaheim, California, United States
• Durata Clinical Site — Buena Park, California, United States
• Durata Study Site — Chula Vista, California, United States
• Durata Clinical Site — Long Beach, California, United States
• Durata Study Site — Los Angeles, California, United States
• Durata Study Site — Norwalk, California, United States
• Durata Study Site — Oxnard, California, United States
• Durata Study SIte — San Diego, California, United States
• Durata Study Site — Stockton, California, United States
• Durata Clinical Site — Boyton Beach, Florida, United States
• Durata Clinical Site — Fort Meyers, Florida, United States
• Durata Clinical Site — Miami, Florida, United States
• Durata Study Site — Orlando, Florida, United States
• Durata Clinical Site — Saint Cloud, Florida, United States
• Durata Clinical Site — Augusta, Georgia, United States
• Durata Study Site — Columbus, Georgia, United States
• Durata Clinical Site — Chicago, Illinois, United States
• Durata Study Site — Baton Rouge, Louisiana, United States
• Durata Study Site — New Orleans, Louisiana, United States
• Durata Study Site — Shreveport, Louisiana, United States
• Durata Study Site — Zachary, Louisiana, United States
• Durata Study Site — Las Vegas, Nevada, United States
• Durata Study Site — Springfield, Ohio, United States
• Durata Study Site — Philadelphia, Pennsylvania, United States
• Durata Clinical Site — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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