- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00107978
Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (ATLAS2)
January 14, 2019 updated by: Cumberland Pharmaceuticals
A Phase 3, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections With a Focus on Patients With Infections Due to Methicillin-resistant Staphylococcus Aureus
Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1035
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
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Louisiana State University Health Sciences Center, Dept of Med/ER Med
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection:
- major abscess requiring surgical incision and drainage;
- infected burn (see exclusion criteria for important qualifications);
- deep/extensive cellulitis;
- infected ulcer (see exclusion criteria for important qualifications);
- wound infections
- Patients must be expected to require at least 7 days of intravenous antibiotic treatment.
Exclusion Criteria:
- Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic therapy
- Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.
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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Telavancin
|
Telavancin 10 mg/kg/day, IV for up to 14 days.
Other Names:
|
ACTIVE_COMPARATOR: Vancomycin
|
Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Response
Time Frame: 7 to 14 days after the last antibiotic dose
|
The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation.
Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.
|
7 to 14 days after the last antibiotic dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Stryjewski ME, Graham DR, Wilson SE, O'Riordan W, Young D, Lentnek A, Ross DP, Fowler VG, Hopkins A, Friedland HD, Barriere SL, Kitt MM, Corey GR; Assessment of Telavancin in Complicated Skin and Skin-Structure Infections Study. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clin Infect Dis. 2008 Jun 1;46(11):1683-93. doi: 10.1086/587896.
- Wilson SE, O'Riordan W, Hopkins A, Friedland HD, Barriere SL, Kitt MM; ATLAS Investigators. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections associated with surgical procedures. Am J Surg. 2009 Jun;197(6):791-6. doi: 10.1016/j.amjsurg.2008.05.012. Epub 2008 Dec 18.
- Stryjewski ME, Barriere SL, O'Riordan W, Dunbar LM, Hopkins A, Genter FC, Corey GR. Efficacy of telavancin in patients with specific types of complicated skin and skin structure infections. J Antimicrob Chemother. 2012 Jun;67(6):1496-502. doi: 10.1093/jac/dks081. Epub 2012 Mar 13.
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
February 1, 2005
Primary Completion (ACTUAL)
May 1, 2006
Study Completion (ACTUAL)
May 1, 2006
Study Registration Dates
First Submitted
April 11, 2005
First Submitted That Met QC Criteria
April 11, 2005
First Posted (ESTIMATE)
April 12, 2005
Study Record Updates
Last Update Posted (ACTUAL)
January 16, 2019
Last Update Submitted That Met QC Criteria
January 14, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Inflammation
- Disease Attributes
- Connective Tissue Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Suppuration
- Skin Diseases, Bacterial
- Infections
- Communicable Diseases
- Cellulitis
- Skin Diseases, Infectious
- Staphylococcal Skin Infections
- Staphylococcal Infections
- Anti-Infective Agents
- Anti-Bacterial Agents
- Vancomycin
- Telavancin
Other Study ID Numbers
- 0018
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.
Clinical Trials on Staphylococcal Skin Infection
-
Aaron ChenJohns Hopkins University; Thrasher Research FundCompletedStaphylococcal Skin Infection | Abscess | Staphylococcal Infection | FolliculitisUnited States
-
Washington University School of MedicineCompletedStaphylococcal Skin Infection | Abscess | Furunculosis | Staphylococcus Aureus | MRSA InfectionUnited States
-
National Institute of Allergy and Infectious Diseases...TerminatedStaphylococcal Aureus Infection | Recurrent Staphylococcal Infection | Invasive Staphylococcal InfectionUnited States
-
Theravance BiopharmaCompletedStaphylococcal Skin InfectionUnited States
-
Cumberland PharmaceuticalsCompletedStaphylococcal Skin InfectionUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedStaphylococcal InfectionUnited States
-
PfizerCompletedBacterial Infections | Staphylococcal Skin Infections | Staphylococcal Infections | Staphylococcal Vaccines | Immunotherapy, ActiveAustralia
-
National Institute of Allergy and Infectious Diseases...CompletedStaphylococcus Aureus Skin InfectionUnited States
-
Washington University School of MedicineCompletedFurunculosis | Staphylococcus Aureus | MRSA Infection | Staphylococcal Skin Infections | AbscessesUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedStaphylococcal InfectionUnited States
Clinical Trials on Telavancin
-
Cumberland PharmaceuticalsCompletedComplicated Skin and Skin Structure Infections | Hospital Acquired Bacterial Pneumonia | Ventilator Associated Bacterial Pneumonia | Gram Positive InfectionUnited States
-
Aaron CookCumberland PharmaceuticalsRecruitingSubarachnoid Hemorrhage, AneurysmalUnited States
-
Joseph L. Kuti, PharmDCumberland Pharmaceuticals, Inc.Completed
-
Cumberland PharmaceuticalsCompletedKidney Diseases | End Stage Renal DiseaseUnited States
-
Hartford HospitalMelinta Therapeutics, LLCNot yet recruiting
-
M.D. Anderson Cancer CenterTheravance BiopharmaCompletedBacteremia | InfectionUnited States
-
University of Illinois at ChicagoTheravance BiopharmaCompleted
-
Cumberland PharmaceuticalsTerminatedGram-Positive Bacterial InfectionsUnited States
-
Cumberland PharmaceuticalsCompleted