- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01339091
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
December 26, 2013 updated by: Durata Therapeutics Inc., an affiliate of Allergan plc
A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Dalbavancin to a Comparator Regiment (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 proven gram-positive bacterial skin or skin structure infection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
573
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0J9
- Durata Study Site
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Quebec
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Trois-Rivieres, Quebec, Canada, G9A 1Y1
- Durata Study Site
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Dubrovnik, Croatia, 2000
- Durata Study Site
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Slavonski Brod, Croatia, 35000
- Durata Clinical Site
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Zagreb, Croatia, 10000
- Durata Study Site
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Zagreb, Croatia, 1000
- Durata Study Site
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Tbilisi, Georgia
- Durata Clinical Site
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Bochum, Germany, 44791
- Durata Study Site
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Munster, Germany, 48149
- Durata Study Site
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Krakow, Poland, 31-501
- Durata Study Site
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Legionowo, Poland, 05-120
- Durata Study Site
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Warszawa, Poland, 03-401
- Durata Study Site
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Wroclaw, Poland, 51-124
- Durata Study Site
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Ekaterinburg, Russian Federation, 620095
- Durata Study Site
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Moscow, Russian Federation, 111020
- Durata Study Site
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Moscow, Russian Federation, 111539
- Durata Clinical Site
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Moscow, Russian Federation, 129327
- Durata Study Site
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Perm, Russian Federation, 614036
- Durata Study Site
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Saratov, Russian Federation, 410053
- Durata Study Site
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Smolensk, Russian Federation, 214018
- Durata Study Site
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St. Petersburg, Russian Federation, 191104
- Durata Study Site
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St. Petersburg, Russian Federation, 192242
- Durata Study Site
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St. Petersburg, Russian Federation, 194354
- Durata Study Site
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St. Petersburg, Russian Federation, 198099
- Durata Study Site
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St. Petersburg, Russian Federation, 94354
- Durata Clinical Site
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Tomsk, Russian Federation, 634064
- Durata Study Site
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Ukraine
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Kharkiv, Ukraine, Russian Federation, 61037
- Durata Study Site
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Kyiv city, Ukraine, Russian Federation, 02125
- Durata Study Site
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Cherkasy, Ukraine, 18009
- Durata Study Site
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Ivano-Frankivsk, Ukraine, 76018
- Durata Study Site
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Kharkiv, Ukraine, 61037
- Durata Study Site
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Kyiv, Ukraine, 02125
- Durata Study Site
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Kyiv, Ukraine, 03110
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Uzhgorod, Ukraine, 88018
- Durata Study Site
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Zaporizhzhya, Ukraine, 69032
- Durata Study Site
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Zhytomyr, Ukraine, 10002
- Durata Study Site
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California
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Anaheim, California, United States, 92804
- Durata Study Site
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Azusa, California, United States, 91702
- Durata Study Site
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Bellflower, California, United States, 90706
- Durata Study Site
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Buena Park, California, United States, 90620
- Durata Study Site
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Carmel, California, United States, 46032
- Durata Study Site
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Chula Vista, California, United States, 92911
- Durata Study Site
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Covina, California, United States, 91723
- Durata Study Site
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Fountain Valley, California, United States, 92708
- Durata Study Site
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La Mesa, California, United States, 91942
- Durata Study Site
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Long Beach, California, United States, 90813
- Durata Study Site
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Los Alamitos, California, United States, 90720
- Durata Study Site
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Los Angeles, California, United States, 90015
- Durata Study Site
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Oceanside, California, United States, 92056
- Durata Study Site
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Palm Desert, California, United States, 92211
- Durata Study Site
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Pasadena, California, United States, 91105
- Durata Study Site
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Sacramento, California, United States, 95817
- Durata Study Site
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San Diego, California, United States, 92120
- Durata Study Site
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Santa Ana, California, United States, 92701
- Durata Study Site
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Sylmar, California, United States, 91342
- Durata Study Site
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Torrance, California, United States, 90509
- Durata Study Site
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Upland, California, United States, 91786
- Durata Study Site
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Whittier, California, United States, 90602
- Durata Study Site
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Florida
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Miami, Florida, United States, 33144
- Durata Study Site
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Miami, Florida, United States, 33155
- Durata Study Site
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Orlando, Florida, United States, 32837
- Durata Study Site
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St. Cloud, Florida, United States, 34769
- Durata Study Site
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Tampa, Florida, United States, 33613
- Durata Study Site
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Georgia
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Columbus, Georgia, United States, 31904
- Durata Study Site
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Savannah, Georgia, United States, 31406
- Durata Study Site
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Durata Study Site
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Pocatello, Idaho, United States, 83202
- Durata Study Site
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Illinois
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Moline, Illinois, United States, 61265
- Durata Study Site
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Rock Island, Illinois, United States, 31201
- Durata Study Site
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Durata Study Site
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Lafayette, Louisiana, United States, 70503
- Durata Study Site
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New Orleans, Louisiana, United States, 70112
- Durata Clinical Site
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Opelousas, Louisiana, United States, 70570
- Durata Study Site
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Michigan
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Detroit, Michigan, United States, 48202
- Durata Study Site
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Minnesota
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Minneapolis, Minnesota, United States, 55422
- Durata Study Site
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Nevada
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Las Vegas, Nevada, United States, 89109
- Durata Study Site
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New Jersey
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Somers Point, New Jersey, United States, 08244
- Durata Study Site
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New York
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Bronx, New York, United States, 10467
- Durata Study Site
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Buffalo, New York, United States, 14215
- Durata Study Site
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Lake Success, New York, United States, 11042
- Durata Study Site
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New Hyde Park, New York, United States, 11040
- Durata Study Site
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Staten Island, New York, United States, 10305
- Durata Study Site
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North Carolina
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Winston Salem, North Carolina, United States, 27103
- Durata Study Site
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Winston-Salem, North Carolina, United States, 27103
- Durata Study Site
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Ohio
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Columbus, Ohio, United States, 43215
- Durata Study Site
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Lima, Ohio, United States, 45801
- Durata Study Site
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Toledo, Ohio, United States, 43608
- Durata Study Site
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Durata Study Site
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Texas
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Houston, Texas, United States, 77030
- Durata Study Site
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Houston, Texas, United States, 77036
- Durata Study Site
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Wisconsin
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Madison, Wisconsin, United States, 53717
- Durata Study Site
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Middleton, Wisconsin, United States, 53562
- Durata Study Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Exclusion Criteria:
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.
- Superficial/simple skin and skin structure infections.
- Concomitant condition requiring non-study antibacterial therapy.
- ABSSSI requiring therapy for longer than 14 days.
- Adjunctive therapy with hyperbaric oxygen.
- More than 2 surgical interventions for ABSSSI anticipated.
- Chronic inflammatory condition precluding assessment of clinical response.
- Absolute neutrophil count < 500 cells/mm3.
- Human immunodeficiency virus (HIV) infection with a CD4 cell count < 200 cells/mm3.
- Recent bone marrow transplant, > 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
- Regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy.
- Life expectancy less than 3 months.
- Conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
- Prior participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Vancomycin with possible switch to oral linezolid
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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.
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Experimental: Dalbavancin
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IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Early Clinical Efficacy
Time Frame: 48-72 hours after the initiation of study therapy
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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
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48-72 hours after the initiation of study therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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>= 20% Reduction in Lesion Area
Time Frame: 48-72 hours after the initiation of study therapy
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Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size
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48-72 hours after the initiation of study therapy
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Clinical Status
Time Frame: End of Treatment Visit (Day 14-15)
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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 non-study antibiotics
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End of Treatment Visit (Day 14-15)
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Clinical Status
Time Frame: Follow-Up Visit (day 28)
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Compare the clinical efficacy at the day 28 follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics
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Follow-Up Visit (day 28)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Michael Dunne, MD, Durata Therapeutics Inc., an affiliate of Allergan plc
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
April 18, 2011
First Submitted That Met QC Criteria
April 19, 2011
First Posted (Estimate)
April 20, 2011
Study Record Updates
Last Update Posted (Estimate)
January 31, 2014
Last Update Submitted That Met QC Criteria
December 26, 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
- DUR001-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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