Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT ID: NCT01431339
Last Updated: 2014-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
739 participants
INTERVENTIONAL
2011-07-31
2012-12-31
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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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 every 12 hours). Total duration of therapy is 10-14 days
Dalbavancin
IV Dalbavancin
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
Interventions
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IV 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 every 12 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 Clinical Site
Montgomery, Alabama, United States
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 Study Site
Austin, Texas, United States
Durata Clinical Site
Austin, Texas, United States
Durata Clinical Site
Houston, Texas, United States
Durata Study Site
Richmond, Texas, United States
Durata Study Site
Middleton, Wisconsin, United States
Durata Study Site
Pleven, , Bulgaria
Durata Study Site
Plovdiv, , Bulgaria
Durata Study Site
Sevlievo, , Bulgaria
Durata Study Site
Sofia, , Bulgaria
Durata Study Site
Sofia, , Bulgaria
Durata Study Site
Sofia, , Bulgaria
Durata Study Site
Sofia, , Bulgaria
Durata Study Site
Kohtla-Järve, , Estonia
Durata Clinical Site
Kohtla-Järve, , Estonia
Durata Clinical Site
Tallinn, , Estonia
Durata Clinical Site
Tallinn, , Estonia
Durata Study Site
Tartu, , Estonia
Durata Study Site
Budapest, , Hungary
Durata Clinical Site
Budapest, , Hungary
Durata Study Site
Debrecen, , Hungary
Durata Clinical Site
Kaposvár, , Hungary
Durata Clinical SIte
Pécs, , Hungary
Durata Clinical Site
Szeged, , Hungary
Durata Study Site
Veszprém, , Hungary
Durata Clinical Site
Haifa, , Israel
Durata Study Site
Jerusalem, , Israel
Durata Clinical Site
Kfar Saba, , Israel
Durata Clinical Site
Petah Tikva, , Israel
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Petah Tikva, , Israel
Durata Clinical Site
Ramat Gan, , Israel
Durata Study Site
Tel Aviv, , Israel
Durata Clinical Site
Daugavpils, , Latvia
Durata Clinical Site
Liepāja, , Latvia
Durata Study Site
Rēzekne, , Latvia
Durata Study Site
Riga, , Latvia
Durata Clinical Site
Riga, , Latvia
Durata Clinical Site
Ventspils, , Latvia
Durata Clinical Site
Kaunas, , Lithuania
Durata Clinical Site
Kauno M. Sav, , Lithuania
Durata Clinical Site
Klaipėda, , Lithuania
Durata Clinical Site
Šiauliai, , Lithuania
Durata Clinical Trial
Vilnius, , Lithuania
Durata Study Site
Bucharest, , Romania
Durata Clinical Site
Bucharest, , Romania
Durata Study Site
Bucharest, , Romania
Durata Clinical Trial
Bucharest, , Romania
Durata Study Site
Bucharest, , Romania
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Burcharest, , Romania
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Cluj-Napoca, , Romania
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Constanța, , Romania
Durata Study Site
Târgu Mureş, , Romania
Durata Clinical Site
Timișoara, , Romania
Durata Clinical Site
Vsevolozhsk, Leningradskaya Oblast', Russia
Durata Study Site
Vsevolozhsk, Leningradskaya Oblast', Russia
Durata Study Site
Moscow, , Russia
Durata Clinical Site
Moscow, , Russia
Durata Study Site
Petrozavodsk, , Russia
Durata Clinical Site
Saint Petersburg, , Russia
Durata Clinical Site
Smolensk, , Russia
Durata Study Site
Tomsk, , Russia
Durata Clinical Site
Tver', , Russia
Durata Clinical Site
Volgograd, , Russia
Durata Clinical Site
Yaroslavl, , Russia
Durata Clinical Site
Banská Bystrica, , Slovakia
Durata Clinical Site
Levice, , Slovakia
Durata Clinical Site
Nitra, , Slovakia
Durata Clinical Site
Svidník, , Slovakia
Durata Study Site
KwaZulu, Durban, South Africa
Durata Study Site
KwaZulu-Natal, Ladysmieth, South Africa
Durata Study Site
Mpumalanga, Middleburg, South Africa
Durata Study Site
Mpekweni, Paarl, South Africa
Durata Study Site
Western Cape, Paarl, South Africa
Durata Clinical Site
Gauteng, Pretoria, South Africa
Durata Study Site
Gauteng, Soweto, South Africa
Durata Study Site
Johannesburg, , South Africa
Durata Study Site
Port Elizabeth, , South Africa
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Port Elizabeth, , South Africa
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Pretoria, , South Africa
Durata Study Site
Thabazimbi, , South Africa
Durata Clinical Site
Jung Gu, Daegu, South Korea
Durata Clinical Site
Ansan, , South Korea
Durata Study Site
Daejeon, , South Korea
Durata Study Site
Gwangju, , South Korea
Durata Clinical Site
Incheon, , South Korea
Durata Clinical Site
Kangwon-do, , South Korea
Durata Study Site
Seoul, , South Korea
Durata Clinical Site
Seoul, , South Korea
Durata Study Site
Seoul, , South Korea
Durata Study Site
Seoul, , South Korea
Durata Clinical Site
Seoul, , South Korea
Durata Study Site
Seoul, , South Korea
Durata Clinical Site
Seoul, , South Korea
Durata Study Site
Tainan, Fukien, Taiwan
Durata Study Site
Kaohsiung City, , Taiwan
Durata Study Site
Kaohsiung City, , Taiwan
Durata Clinical Site
Taichung, , Taiwan
Durata Clinical Site
Taipai, , Taiwan
Durata Study Site
Taipei, , Taiwan
Durata Study Site
Yung Kang City, , Taiwan
Durata Study Site
Cherkasy, , Ukraine
Durata Study Site
Dnipropetrovsk, , Ukraine
Durata Study Site
Donetsk, , Ukraine
Durata Clinical Site
Ivano-Frankivsk, , Ukraine
Durata Study Site
Ivano-Frankivsk, , Ukraine
Durata Study Site
Ivano-Frankivsk, , Ukraine
Durata Study Site
Kharkiv, , Ukraine
Durata Clinical Site
Kyiv, , Ukraine
Durata Study Site
Kyiv, , Ukraine
Durata Study Site
Lviv, , Ukraine
Durata Study Site
Lviv, , Ukraine
Durata Study Site
Uzhhorod, , Ukraine
Durata Study Site
Zaporizhia, , 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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DUR001-302
Identifier Type: -
Identifier Source: org_study_id
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