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

NCT01339091 | Completed Phase 3 Results

• 1 other identifier: DUR001-301
• Study Type: interventional
• Target: 573
• Locations: 8 countries
• Sites: 91

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 proven gram-positive bacterial skin or skin structure infection.

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

  48-72 hours after the initiation of study therapy

Secondary Outcomes (3)

• >= 20% Reduction in Lesion Area

  48-72 hours after the initiation of study therapy

• Clinical Status

  End of Treatment Visit (Day 14-15)

• Clinical Status

  Follow-Up Visit (day 28)

Study Arms (2)

Dalbavancin

EXPERIMENTAL

Drug: Dalbavancin

Vancomycin with possible switch to oral linezolid

ACTIVE COMPARATOR

Drug: Vancomycin / Linezolid

Interventions

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 Q12 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 (91)

Durata Study Site

Anaheim, California, 92804, United States

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Azusa, California, 91702, United States

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Bellflower, California, 90706, United States

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Buena Park, California, 90620, United States

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Carmel, California, 46032, United States

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Chula Vista, California, 92911, United States

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Covina, California, 91723, United States

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Fountain Valley, California, 92708, United States

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La Mesa, California, 91942, United States

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Long Beach, California, 90813, United States

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Los Alamitos, California, 90720, United States

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Los Angeles, California, 90015, United States

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Oceanside, California, 92056, United States

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Palm Desert, California, 92211, United States

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Pasadena, California, 91105, United States

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Sacramento, California, 95817, United States

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San Diego, California, 92120, United States

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Santa Ana, California, 92701, United States

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Sylmar, California, 91342, United States

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Torrance, California, 90509, United States

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Upland, California, 91786, United States

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Whittier, California, 90602, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33155, 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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Tampa, Florida, 33613, United States

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Columbus, Georgia, 31904, United States

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Savannah, Georgia, 31406, United States

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Idaho Falls, Idaho, 83404, United States

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Pocatello, Idaho, 83202, United States

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Moline, Illinois, 61265, United States

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Rock Island, Illinois, 31201, United States

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Baton Rouge, Louisiana, 70808, United States

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Lafayette, Louisiana, 70503, United States

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New Orleans, Louisiana, 70112, United States

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Opelousas, Louisiana, 70570, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55422, United States

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Las Vegas, Nevada, 89109, United States

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Somers Point, New Jersey, 08244, United States

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Buffalo, New York, 14215, United States

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Lake Success, New York, 11042, United States

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New Hyde Park, New York, 11040, United States

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Staten Island, New York, 10305, United States

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The Bronx, New York, 10467, United States

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Winston-Salem, North Carolina, 27103, United States

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Columbus, Ohio, 43215, United States

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Lima, Ohio, 45801, United States

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Toledo, Ohio, 43608, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77036, United States

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Madison, Wisconsin, 53717, United States

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Middleton, Wisconsin, 53562, United States

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Winnipeg, Manitoba, R3E 0J9, Canada

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Trois-Rivières, Quebec, G9A 1Y1, Canada

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Dubrovnik, 2000, Croatia

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Slavonski Brod, 35000, Croatia

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Zagreb, 10000, Croatia

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Zagreb, 1000, Croatia

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Tbilisi, Georgia

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Bochum, 44791, Germany

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Münster, 48149, Germany

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Krakow, 31-501, Poland

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Legionowo, 05-120, Poland

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Warsaw, 03-401, Poland

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Wroclaw, 51-124, Poland

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Kharkiv, Ukraine, 61037, Russia

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Kyiv City, Ukraine, 02125, Russia

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Moscow, 111020, Russia

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Moscow, 111539, Russia

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Moscow, 129327, Russia

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Perm, 614036, Russia

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Saint Petersburg, 191104, Russia

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Saint Petersburg, 192242, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 198099, Russia

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Saint Petersburg, 94354, Russia

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Saratov, 410053, Russia

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Smolensk, 214018, Russia

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Tomsk, 634064, Russia

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Yekaterinburg, 620095, Russia

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Cherkasy, 18009, Ukraine

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Ivano-Frankivsk, 76018, Ukraine

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Kharkiv, 61037, Ukraine

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Kyiv, 02125, Ukraine

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Kyiv, 03110, Ukraine

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Uzhhorod, 88018, Ukraine

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Zaporizhzhya, 69032, Ukraine

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Zhytomyr, 10002, 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@duratatherapeutics.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: April 18, 2011
• First Posted: April 20, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 31, 2014
• Results First Posted: December 25, 2013

Record last verified: 2013-12

Locations

RU (15); CA (2); DE (2); US (55); GE (1); UA (8); CR (4); PL (4)