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Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE)
This study has been completed.
Sponsor:
Theravance Biopharma Antibiotics, Inc.
Information provided by:
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT00062647
First received: June 9, 2003
Last updated: March 30, 2011
Last verified: March 2011
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Purpose
The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.
| Condition | Intervention | Phase |
|---|---|---|
| Gram-Positive Bacterial Infections | Drug: Telavancin Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Televancin (TD-6424) for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia |
Resource links provided by NLM:
Drug Information available for:
Oxacillin
Nafcillin
Cloxacillin Sodium
Nafcillin sodium
Oxacillin sodium
Vancomycin
Vancomycin hydrochloride
Telavancin
Telavancin hydrochloride
U.S. FDA Resources
Further study details as provided by Theravance Biopharma Antibiotics, Inc.:
Primary Outcome Measures:
- Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation [ Time Frame: 12 weeks after start of treatment ]Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.
| Enrollment: | 60 |
| Study Start Date: | August 2003 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Telavancin |
Drug: Telavancin
Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days
Other Names:
|
|
Active Comparator: Vancomycin, nafcillin, oxacillin, or cloxacillin
Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously
|
Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin
Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Documented S. aureus bacteremia
Exclusion Criteria
- Patients who had received or would have received more than 72 hours of potentially effective systemic antistaphylococcal therapy within 7 days prior to randomization. The following agents were considered potentially effective antistaphylococcal therapy: antistaphylococcal penicillins (including nafcillin, oxacillin, or cloxacillin), cephalosporins, fluoroquinolones, glycopeptides (including vancomycin and teicoplanin) and linezolid
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062647
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062647
Locations
| United States, Georgia | |
| Wellstar Infectious Disease | |
| Marietta, Georgia, United States, 30060 | |
Sponsors and Collaborators
Theravance Biopharma Antibiotics, Inc.
Investigators
| Principal Investigator: | G. Ralph Corey, MD | Duke University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Steven L. Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc. |
| ClinicalTrials.gov Identifier: | NCT00062647 History of Changes |
| Other Study ID Numbers: |
I6424-203a |
| Study First Received: | June 9, 2003 |
| Results First Received: | December 2, 2009 |
| Last Updated: | March 30, 2011 |
Additional relevant MeSH terms:
|
Bacterial Infections Bacteremia Gram-Positive Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Vancomycin Telavancin Cloxacillin Oxacillin Nafcillin Anti-Bacterial Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on August 16, 2017