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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
573

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0J9
        • Durata Study Site
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G9A 1Y1
        • Durata Study Site
  • Croatia
      • Dubrovnik, Croatia, 2000
        • Durata Study Site
      • Slavonski Brod, Croatia, 35000
        • Durata Clinical Site
      • Zagreb, Croatia, 10000
        • Durata Study Site
      • Zagreb, Croatia, 1000
        • Durata Study Site
  • Georgia
      • Tbilisi, Georgia
        • Durata Clinical Site
  • Germany
      • Bochum, Germany, 44791
        • Durata Study Site
      • Munster, Germany, 48149
        • Durata Study Site
  • Poland
      • Krakow, Poland, 31-501
        • Durata Study Site
      • Legionowo, Poland, 05-120
        • Durata Study Site
      • Warszawa, Poland, 03-401
        • Durata Study Site
      • Wroclaw, Poland, 51-124
        • Durata Study Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620095
        • Durata Study Site
      • Moscow, Russian Federation, 111020
        • Durata Study Site
      • Moscow, Russian Federation, 111539
        • Durata Clinical Site
      • Moscow, Russian Federation, 129327
        • Durata Study Site
      • Perm, Russian Federation, 614036
        • Durata Study Site
      • Saratov, Russian Federation, 410053
        • Durata Study Site
      • Smolensk, Russian Federation, 214018
        • Durata Study Site
      • St. Petersburg, Russian Federation, 191104
        • Durata Study Site
      • St. Petersburg, Russian Federation, 192242
        • Durata Study Site
      • St. Petersburg, Russian Federation, 194354
        • Durata Study Site
      • St. Petersburg, Russian Federation, 198099
        • Durata Study Site
      • St. Petersburg, Russian Federation, 94354
        • Durata Clinical Site
      • Tomsk, Russian Federation, 634064
        • Durata Study Site
    • Ukraine
      • Kharkiv, Ukraine, Russian Federation, 61037
        • Durata Study Site
      • Kyiv city, Ukraine, Russian Federation, 02125
        • Durata Study Site
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Durata Study Site
      • Ivano-Frankivsk, Ukraine, 76018
        • Durata Study Site
      • Kharkiv, Ukraine, 61037
        • Durata Study Site
      • Kyiv, Ukraine, 02125
        • Durata Study Site
      • Kyiv, Ukraine, 03110
        • Durata Study Site
      • Uzhgorod, Ukraine, 88018
        • Durata Study Site
      • Zaporizhzhya, Ukraine, 69032
        • Durata Study Site
      • Zhytomyr, Ukraine, 10002
        • Durata Study Site
  • United States
    • California
      • Anaheim, California, United States, 92804
        • Durata Study Site
      • Azusa, California, United States, 91702
        • Durata Study Site
      • Bellflower, California, United States, 90706
        • Durata Study Site
      • Buena Park, California, United States, 90620
        • Durata Study Site
      • Carmel, California, United States, 46032
        • Durata Study Site
      • Chula Vista, California, United States, 92911
        • Durata Study Site
      • Covina, California, United States, 91723
        • Durata Study Site
      • Fountain Valley, California, United States, 92708
        • Durata Study Site
      • La Mesa, California, United States, 91942
        • Durata Study Site
      • Long Beach, California, United States, 90813
        • Durata Study Site
      • Los Alamitos, California, United States, 90720
        • Durata Study Site
      • Los Angeles, California, United States, 90015
        • Durata Study Site
      • Oceanside, California, United States, 92056
        • Durata Study Site
      • Palm Desert, California, United States, 92211
        • Durata Study Site
      • Pasadena, California, United States, 91105
        • Durata Study Site
      • Sacramento, California, United States, 95817
        • Durata Study Site
      • San Diego, California, United States, 92120
        • Durata Study Site
      • Santa Ana, California, United States, 92701
        • Durata Study Site
      • Sylmar, California, United States, 91342
        • Durata Study Site
      • Torrance, California, United States, 90509
        • Durata Study Site
      • Upland, California, United States, 91786
        • Durata Study Site
      • Whittier, California, United States, 90602
        • Durata Study Site
    • Florida
      • Miami, Florida, United States, 33144
        • Durata Study Site
      • Miami, Florida, United States, 33155
        • Durata Study Site
      • Orlando, Florida, United States, 32837
        • Durata Study Site
      • St. Cloud, Florida, United States, 34769
        • Durata Study Site
      • Tampa, Florida, United States, 33613
        • Durata Study Site
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Durata Study Site
      • Savannah, Georgia, United States, 31406
        • Durata Study Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Durata Study Site
      • Pocatello, Idaho, United States, 83202
        • Durata Study Site
    • Illinois
      • Moline, Illinois, United States, 61265
        • Durata Study Site
      • Rock Island, Illinois, United States, 31201
        • Durata Study Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Durata Study Site
      • Lafayette, Louisiana, United States, 70503
        • Durata Study Site
      • New Orleans, Louisiana, United States, 70112
        • Durata Clinical Site
      • Opelousas, Louisiana, United States, 70570
        • Durata Study Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Durata Study Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55422
        • Durata Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Durata Study Site
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • Durata Study Site
    • New York
      • Bronx, New York, United States, 10467
        • Durata Study Site
      • Buffalo, New York, United States, 14215
        • Durata Study Site
      • Lake Success, New York, United States, 11042
        • Durata Study Site
      • New Hyde Park, New York, United States, 11040
        • Durata Study Site
      • Staten Island, New York, United States, 10305
        • Durata Study Site
    • North Carolina
      • Winston Salem, North Carolina, United States, 27103
        • Durata Study Site
      • Winston-Salem, North Carolina, United States, 27103
        • Durata Study Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Durata Study Site
      • Lima, Ohio, United States, 45801
        • Durata Study Site
      • Toledo, Ohio, United States, 43608
        • Durata Study Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Durata Study Site
    • Texas
      • Houston, Texas, United States, 77030
        • Durata Study Site
      • Houston, Texas, United States, 77036
        • Durata Study Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • Durata Study Site
      • Middleton, Wisconsin, United States, 53562
        • Durata Study Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Q12 hours). Total duration of therapy is 10-14 days.
Experimental: Dalbavancin
Drug: Dalbavancin
IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early Clinical Efficacy
Time Frame: 48-72 hours after the initiation of study therapy
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
>= 20% Reduction in Lesion Area
Time Frame: 48-72 hours after the initiation of study therapy
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
Time Frame: End of Treatment Visit (Day 14-15)
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
End of Treatment Visit (Day 14-15)
Clinical Status
Time Frame: Follow-Up Visit (day 28)
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
Follow-Up Visit (day 28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Durata Therapeutics Inc., an affiliate of Allergan plc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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