Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT ID: NCT01339091
Last Updated: 2014-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
573 participants
INTERVENTIONAL
2011-03-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dalbavancin
Dalbavancin
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
Vancomycin with possible switch to oral linezolid
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.
Interventions
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Dalbavancin
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
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 Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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Durata Therapeutics Inc., an affiliate of Allergan plc
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Dunne, MD
Role: STUDY_DIRECTOR
Durata Therapeutics Inc., an affiliate of Allergan plc
Locations
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Durata Study Site
Anaheim, California, United States
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Azusa, California, United States
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Bellflower, California, United States
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Buena Park, California, United States
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Carmel, California, United States
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Chula Vista, California, United States
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Covina, California, United States
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Fountain Valley, California, United States
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La Mesa, California, United States
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Long Beach, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Palm Desert, California, United States
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Pasadena, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Sylmar, California, United States
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Torrance, California, United States
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Upland, California, United States
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Whittier, California, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Saint Cloud, Florida, United States
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Tampa, Florida, United States
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Columbus, Georgia, United States
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Savannah, Georgia, United States
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Idaho Falls, Idaho, United States
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Pocatello, Idaho, United States
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Moline, Illinois, United States
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Rock Island, Illinois, United States
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Baton Rouge, Louisiana, United States
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Lafayette, Louisiana, United States
Durata Clinical Site
New Orleans, Louisiana, United States
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Opelousas, Louisiana, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Las Vegas, Nevada, United States
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Somers Point, New Jersey, United States
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Buffalo, New York, United States
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Lake Success, New York, United States
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New Hyde Park, New York, United States
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Staten Island, New York, United States
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The Bronx, New York, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Lima, Ohio, United States
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Toledo, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Madison, Wisconsin, United States
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Middleton, Wisconsin, United States
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Winnipeg, Manitoba, Canada
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Trois-Rivières, Quebec, Canada
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Dubrovnik, , Croatia
Durata Clinical Site
Slavonski Brod, , Croatia
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Zagreb, , Croatia
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Zagreb, , Croatia
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Tbilisi, , Georgia
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Bochum, , Germany
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Münster, , Germany
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Krakow, , Poland
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Legionowo, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Kharkiv, Ukraine, Russia
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Kyiv City, Ukraine, Russia
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Moscow, , Russia
Durata Clinical Site
Moscow, , Russia
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Moscow, , Russia
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Perm, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
Durata Clinical Site
Saint Petersburg, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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Tomsk, , Russia
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Yekaterinburg, , Russia
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Cherkasy, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Uzhhorod, , Ukraine
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Zaporizhzhya, , Ukraine
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Zhytomyr, , Ukraine
Countries
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References
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Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):423-434. doi: 10.1007/s40121-021-00568-7. Epub 2021 Dec 14.
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.
Other Identifiers
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DUR001-301
Identifier Type: -
Identifier Source: org_study_id