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

NCT01431339 | Completed Phase 3 Results

• 1 other identifier: DUR001-302
• Study Type: interventional
• Target: 739
• Locations: 14 countries
• Sites: 137

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 treatment of patients with a suspected or proved gram-positive bacterial skin or skin structure infections.

Conditions

Abscess; Wound Infection; Surgical Site Infection; Cellulitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical Status

  End of Treatment Visit (Day 14-15)

• >= 20% Reduction in Lesion Area

  48-72 hours after the initiation of study therapy

• Clinical Status

  Follow-Up Visit (day 28)

Study Arms (2)

Vancomycin with possible switch to oral linezolid

ACTIVE COMPARATOR

Drug: Vancomycin/Linezolid

Dalbavancin

EXPERIMENTAL

Drug: IV Dalbavancin

Interventions

IV Dalbavancin DRUG

IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8

Dalbavancin

Vancomycin/Linezolid DRUG

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

Vancomycin with possible switch to oral linezolid

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Durata Therapeutics Inc., an affiliate of Allergan plc: lead

Study Sites (137)

Durata Clinical Site

Montgomery, Alabama, 36106, United States

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Anaheim, California, 92804, United States

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Buena Park, California, 90620, United States

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Chula Vista, California, 91911, United States

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Long Beach, California, 90813, United States

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Los Angeles, California, 90015, United States

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Norwalk, California, 90650, United States

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Oxnard, California, 93030, United States

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San Diego, California, 92120, United States

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Stockton, California, 95204, United States

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Boyton Beach, Florida, 33435, United States

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Fort Meyers, Florida, 33966, United States

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Miami, Florida, 33015, United States

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Orlando, Florida, 32837, United States

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Saint Cloud, Florida, 34769, United States

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Augusta, Georgia, 30901, United States

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Columbus, Georgia, 31904, United States

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Chicago, Illinois, 60637, United States

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Baton Rouge, Louisiana, 70809, United States

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New Orleans, Louisiana, 70112, United States

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Shreveport, Louisiana, 71101, United States

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Zachary, Louisiana, 70791, United States

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Las Vegas, Nevada, 89109, United States

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Springfield, Ohio, 45502, United States

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Philadelphia, Pennsylvania, 19103, United States

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Austin, Texas, 78701, United States

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Austin, Texas, 78752, United States

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Houston, Texas, 77055, United States

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Richmond, Texas, 77469, United States

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Middleton, Wisconsin, 53562, United States

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Pleven, 5800, Bulgaria

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Plovdiv, 4000, Bulgaria

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Sevlievo, 5400, Bulgaria

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Sofia, 1000, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1606, Bulgaria

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Kohtla-Järve, 30322, Estonia

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Kohtla-Järve, Estonia

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Tallinn, 10136, Estonia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Budapest, H-1081, Hungary

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Budapest, Hungary

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Debrecen, H-4043, Hungary

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Kaposvár, H-7400, Hungary

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Pécs, H-7624, Hungary

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Szeged, H-6720, Hungary

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Veszprém, H-8200, Hungary

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Haifa, 31906, Israel

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Jerusalem, 91120, Israel

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Kfar Saba, 44281, Israel

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Petah Tikva, 49100, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 52621, Israel

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Tel Aviv, 64239, Israel

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Daugavpils, LV-5417, Latvia

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Liepāja, LV-3414, Latvia

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Rēzekne, LV-4600, Latvia

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Riga, LV-1001, Latvia

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Riga, LV-1002, Latvia

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Ventspils, LV-3601, Latvia

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Kaunas, LT-45130, Lithuania

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Kauno M. Sav, LT-47144, Lithuania

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Klaipėda, LT-76231, Lithuania

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Šiauliai, LT-76231, Lithuania

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Vilnius, LT-10207, Lithuania

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Bucharest, 010713, Romania

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Bucharest, 010825, Romania

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Bucharest, 011461, Romania

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Bucharest, 042122, Romania

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Bucharest, 75622, Romania

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Burcharest, 020125, Romania

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Cluj-Napoca, 400006, Romania

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Constanța, 900709, Romania

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Târgu Mureş, 540072, Romania

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Timișoara, 300736, Romania

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Vsevolozhsk, Leningradskaya Oblast', 188640, Russia

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Vsevolozhsk, Leningradskaya Oblast', 188864, Russia

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Moscow, 111539, Russia

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Moscow, 115280, Russia

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Petrozavodsk, 18519, Russia

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Saint Petersburg, 198099, Russia

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Smolensk, 214018, Russia

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Tomsk, Russia

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Tver', 170036, Russia

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Volgograd, 400138, Russia

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Yaroslavl, 150003, Russia

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Banská Bystrica, 975 17, Slovakia

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Levice, 934 01, Slovakia

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Nitra, 950 01, Slovakia

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Svidník, 089 01, Slovakia

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KwaZulu, Durban, 4037, South Africa

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KwaZulu-Natal, Ladysmieth, 3370, South Africa

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Mpumalanga, Middleburg, 1055, South Africa

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Mpekweni, Paarl, 7646, South Africa

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Western Cape, Paarl, 7646, South Africa

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Gauteng, Pretoria, 0001, South Africa

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Gauteng, Soweto, 2013, South Africa

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Johannesburg, 1500, South Africa

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Port Elizabeth, 6014, South Africa

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Port Elizabeth, 6070, South Africa

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Pretoria, 0084, South Africa

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Thabazimbi, 0380, South Africa

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Jung Gu, Daegu, 700-721, South Korea

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Ansan, 425-707, South Korea

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Daejeon, 301721, South Korea

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Gwangju, 501-757, South Korea

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Incheon, 405-760, South Korea

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Kangwon-do, 220-71, South Korea

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Seoul, 133-791, South Korea

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Seoul, 134-701, South Korea

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Seoul, 134-701, South Korea

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Seoul, 135-710, South Korea

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Seoul, 136-705, South Korea

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Seoul, 138-736, South Korea

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Seoul, 152-703, South Korea

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Tainan, Fukien, 70403, Taiwan

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Kaohsiung City, 813, Taiwan

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Kaohsiung City, ROC 807, Taiwan

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Taichung, 40447, Taiwan

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Taipai, Taiwan

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Taipei, 10002, Taiwan

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Yung Kang City, 71044, Taiwan

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Cherkasy, 18009, Ukraine

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Dnipropetrovsk, 49005, Ukraine

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Donetsk, 83099, Ukraine

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Ivano-Frankivsk, 76014, Ukraine

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Ivano-Frankivsk, 76014, Ukraine

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Ivano-Frankivsk, 76025, Ukraine

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Kharkiv, 61058, Ukraine

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Kyiv, 02666, Ukraine

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Kyiv, 02666, Ukraine

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Lviv, 79013, Ukraine

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Lviv, 79059, Ukraine

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Uzhhorod, 88000, Ukraine

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Zaporizhia, 69032, Ukraine

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Related Publications (2)

• 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.

  PMID: 34905144 DERIVED

• 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.

  PMID: 24897082 DERIVED

MeSH Terms

Conditions

Abscess; Wound Infection; Surgical Wound Infection; Cellulitis

Interventions

dalbavancin; Vancomycin; Linezolid

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Skin Diseases, Infectious; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Michael Zelasky
• Organization: Durata Therapeutics

mzelasky@duratatx.com

203-871-4616

Study Officials

• Michael Dunne, MD

  Durata Therapeutics Inc., an affiliate of Allergan plc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 9, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 12, 2014
• Results First Posted: February 12, 2014

Record last verified: 2013-12

Locations

US (30); LA (6); UA (13); SL (4); BU (7); ES (5); IL (7); HU (7); LI (5); RU (11); RO (10); ZA (12); KR (13); TW (7)