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.

Study Overview

• Status: Completed
• Conditions: Abscess; Cellulitis; Surgical Site Infection; Wound Infection
• Intervention / Treatment: Drug: Vancomycin/Linezolid; Drug: IV Dalbavancin

• Study Type: Interventional
• Enrollment (Actual): 739
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria, 5800
    • Durata Study Site
  • Plovdiv, Bulgaria, 4000
    • Durata Study Site
  • Sevlievo, Bulgaria, 5400
    • Durata Study Site
  • Sofia, Bulgaria, 1000
    • Durata Study Site
  • Sofia, Bulgaria, 1407
    • Durata Study Site
  • Sofia, Bulgaria, 1431
    • Durata Study Site
  • Sofia, Bulgaria, 1606
    • Durata Study Site
• Estonia
  • Kohtla-Jarve, Estonia, 30322
    • Durata Study Site
  • Kohtla-Jarve, Estonia
    • Durata Clinical Site
  • Tallinn, Estonia, 10136
    • Durata Clinical Site
  • Tallinn, Estonia, 13419
    • Durata Clinical Site
  • Tartu, Estonia, 51014
    • Durata Study Site
• Hungary
  • Budapest, Hungary, H-1081
    • Durata Study Site
  • Budapest, Hungary
    • Durata Clinical Site
  • Debrecen, Hungary, H-4043
    • Durata Study Site
  • Kaposvar, Hungary, H-7400
    • Durata Clinical Site
  • Pecs, Hungary, H-7624
    • Durata Clinical Site
  • Szeged, Hungary, H-6720
    • Durata Clinical Site
  • Veszprem, Hungary, H-8200
    • Durata Study Site
• Israel
  • Haifa, Israel, 31906
    • Durata Clinical Site
  • Jerusalem, Israel, 91120
    • Durata Study Site
  • Kfar Saba, Israel, 44281
    • Durata Clinical Site
  • Petach Tikva, Israel, 49100
    • Durata Study Site
  • Petah-Tiqva, Israel, 49100
    • Durata Clinical Site
  • Ramat-Gan, Israel, 52621
    • Durata Clinical Site
  • Tel Aviv, Israel, 64239
    • Durata Study Site
• Korea, Republic of
  • Ansan, Korea, Republic of, 425-707
    • Durata Clinical Site
  • Daejeon, Korea, Republic of, 301721
    • Durata Study Site
  • Gwangju, Korea, Republic of, 501-757
    • Durata Study Site
  • Incheon, Korea, Republic of, 405-760
    • Durata Clinical Site
  • Kangwon-do, Korea, Republic of, 220-71
    • Durata Clinical Site
  • Seoul, Korea, Republic of, 133-791
    • Durata Study Site
  • Seoul, Korea, Republic of, 134-701
    • Durata Clinical Site
  • Seoul, Korea, Republic of, 134-701
    • Durata Study Site
  • Seoul, Korea, Republic of, 135-710
    • Durata Study Site
  • Seoul, Korea, Republic of, 136-705
    • Durata Clinical Site
  • Seoul, Korea, Republic of, 138-736
    • Durata Study Site
  • Seoul, Korea, Republic of, 152-703
    • Durata Clinical Site
  • Daegu
    • Jung Gu, Daegu, Korea, Republic of, 700-721
      • Durata Clinical Site
• Latvia
  • Daugavpils, Latvia, LV-5417
    • Durata Clinical Site
  • Liepaja, Latvia, LV-3414
    • Durata Clinical Site
  • Rezekne, Latvia, LV-4600
    • Durata Study Site
  • Riga, Latvia, LV-1001
    • Durata Study Site
  • Riga, Latvia, LV-1002
    • Durata Clinical Site
  • Ventspils, Latvia, LV-3601
    • Durata Clinical Site
• Lithuania
  • Kaunas, Lithuania, LT-45130
    • Durata Clinical Site
  • Kauno m. sav, Lithuania, LT-47144
    • Durata Clinical Site
  • Klaipėda, Lithuania, LT-76231
    • Durata Clinical Site
  • Vilnius, Lithuania, LT-10207
    • Durata Clinical Trial
  • Šiauliai, Lithuania, LT-76231
    • Durata Clinical Site
• Romania
  • Bucharest, Romania, 010713
    • Durata Study Site
  • Bucharest, Romania, 010825
    • Durata Clinical Site
  • Bucharest, Romania, 011461
    • Durata Study Site
  • Bucharest, Romania, 042122
    • Durata Clinical Trial
  • Bucharest, Romania, 75622
    • Durata Study Site
  • Burcharest, Romania, 020125
    • Durata Clinical Site
  • Cluj-Napoca, Romania, 400006
    • Durata Study Site
  • Constanta, Romania, 900709
    • Durata Study Site
  • Targu Mures, Romania, 540072
    • Durata Study Site
  • Timisoara, Romania, 300736
    • Durata Clinical Site
• Russian Federation
  • Moscow, Russian Federation, 111539
    • Durata Study Site
  • Moscow, Russian Federation, 115280
    • Durata Clinical Site
  • Petrozavodsk, Russian Federation, 18519
    • Durata Study Site
  • Smolensk, Russian Federation, 214018
    • Durata Clinical Site
  • St. Petersburg, Russian Federation, 198099
    • Durata Clinical Site
  • Tomsk, Russian Federation
    • Durata Study Site
  • Tver, Russian Federation, 170036
    • Durata Clinical Site
  • Volgograd, Russian Federation, 400138
    • Durata Clinical Site
  • Yaroslavl, Russian Federation, 150003
    • Durata Clinical Site
  • Leningrad
    • Vsevolozhsk, Leningrad, Russian Federation, 188864
      • Durata Study Site
  • Leningrad Region
    • Vsevolozhsk, Leningrad Region, Russian Federation, 188640
      • Durata Clinical Site
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Durata Clinical Site
  • Levice, Slovakia, 934 01
    • Durata Clinical Site
  • Nitra, Slovakia, 950 01
    • Durata Clinical Site
  • Svidnik, Slovakia, 089 01
    • Durata Clinical Site
• South Africa
  • Johannesburg, South Africa, 1500
    • Durata Study Site
  • Port Elizabeth, South Africa, 6014
    • Durata Study Site
  • Port Elizabeth, South Africa, 6070
    • Durata Study Site
  • Pretoria, South Africa, 0084
    • Durata Clinical Site
  • Thabazimbi, South Africa, 0380
    • Durata Study Site
  • Durban
    • KwaZulu, Durban, South Africa, 4037
      • Durata Study Site
  • Ladysmieth
    • KwaZulu-Natal, Ladysmieth, South Africa, 3370
      • Durata Study Site
  • Middleburg
    • Mpumalanga, Middleburg, South Africa, 1055
      • Durata Study Site
  • Paarl
    • Mpekweni, Paarl, South Africa, 7646
      • Durata Study Site
    • Western Cape, Paarl, South Africa, 7646
      • Durata Study Site
  • Pretoria
    • Gauteng, Pretoria, South Africa, 0001
      • Durata Clinical Site
  • Soweto
    • Gauteng, Soweto, South Africa, 2013
      • Durata Study Site
• Taiwan
  • Kaohsiung, Taiwan, 813
    • Durata Study Site
  • Kaohsiung, Taiwan, ROC 807
    • Durata Study Site
  • Taichung City, Taiwan, 40447
    • Durata Clinical Site
  • Taipai, Taiwan
    • Durata Clinical Site
  • Taipei, Taiwan, 10002
    • Durata Study Site
  • Yung Kang City, Taiwan, 71044
    • Durata Study Site
  • Fukien
    • Tainan, Fukien, Taiwan, 70403
      • Durata Study Site
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Durata Study Site
  • Dnipropetrovsk, Ukraine, 49005
    • Durata Study Site
  • Donetsk, Ukraine, 83099
    • Durata Study Site
  • Ivano-Frankivsk, Ukraine, 76014
    • Durata Clinical Site
  • Ivano-Frankivsk, Ukraine, 76014
    • Durata Study Site
  • Ivano-Frankivsk, Ukraine, 76025
    • Durata Study Site
  • Kharkiv, Ukraine, 61058
    • Durata Study Site
  • Kyiv, Ukraine, 02666
    • Durata Clinical Site
  • Kyiv, Ukraine, 02666
    • Durata Study Site
  • Lviv, Ukraine, 79013
    • Durata Study Site
  • Lviv, Ukraine, 79059
    • Durata Study Site
  • Uzhhorod, Ukraine, 88000
    • Durata Study Site
  • Zaporizhia, Ukraine, 69032
    • Durata Study Site
• United States
  • Alabama
    • Montgomery, Alabama, United States, 36106
      • Durata Clinical Site
  • California
    • Anaheim, California, United States, 92804
      • Durata Clinical Site
    • Buena Park, California, United States, 90620
      • Durata Clinical Site
    • Chula Vista, California, United States, 91911
      • Durata Study Site
    • Long Beach, California, United States, 90813
      • Durata Clinical Site
    • Los Angeles, California, United States, 90015
      • Durata Study Site
    • Norwalk, California, United States, 90650
      • Durata Study Site
    • Oxnard, California, United States, 93030
      • Durata Study Site
    • San Diego, California, United States, 92120
      • Durata Study Site
    • Stockton, California, United States, 95204
      • Durata Study Site
  • Florida
    • Boyton Beach, Florida, United States, 33435
      • Durata Clinical Site
    • Ft. Meyers, Florida, United States, 33966
      • Durata Clinical Site
    • Miami, Florida, United States, 33015
      • Durata Clinical Site
    • Orlando, Florida, United States, 32837
      • Durata Study Site
    • St. Cloud, Florida, United States, 34769
      • Durata Clinical Site
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Durata Clinical Site
    • Columbus, Georgia, United States, 31904
      • Durata Study Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Durata Clinical Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Durata Study Site
    • New Orleans, Louisiana, United States, 70112
      • Durata Study Site
    • Shreveport, Louisiana, United States, 71101
      • Durata Study Site
    • Zachary, Louisiana, United States, 70791
      • Durata Study Site
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Durata Study Site
  • Ohio
    • Springfield, Ohio, United States, 45502
      • Durata Study Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Durata Study Site
  • Texas
    • Austin, Texas, United States, 78701
      • Durata Study Site
    • Austin, Texas, United States, 78752
      • Durata Clinical Site
    • Houston, Texas, United States, 77055
      • Durata Clinical Site
    • Richmond, Texas, United States, 77469
      • Durata Study Site
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Durata Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vancomycin with possible switch to oral linezolid	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
Experimental: Dalbavancin	Drug: IV Dalbavancin; IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Clinical Efficacy	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	After 48-72 hours of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Status	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	End of Treatment Visit (Day 14-15)
>= 20% Reduction in Lesion Area	Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size	48-72 hours after the initiation of study therapy
Clinical Status	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	Follow-Up Visit (day 28)

Collaborators and Investigators

• Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc
• Investigators: Study Director: Michael Dunne, MD, Durata Therapeutics Inc., an affiliate of Allergan plc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 8, 2011
• First Submitted That Met QC Criteria: September 8, 2011
• First Posted (Estimate): September 9, 2011

Study Record Updates

• Last Update Posted (Estimate): February 12, 2014
• Last Update Submitted That Met QC Criteria: December 27, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Postoperative Complications; Disease Attributes; Connective Tissue Diseases; Skin Diseases, Infectious; Suppuration; Infections; Communicable Diseases; Cellulitis; Surgical Wound Infection; Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Vancomycin; Linezolid; Dalbavancin
• Other Study ID Numbers: DUR001-302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No