Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE)
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ClinicalTrials.gov Identifier: NCT00062647 |
Recruitment Status :
Completed
First Posted : June 12, 2003
Results First Posted : March 22, 2011
Last Update Posted : January 16, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gram-Positive Bacterial Infections | Drug: Telavancin Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (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 |
Study Start Date : | August 2003 |
Actual Primary Completion Date : | August 2006 |
Actual Study Completion Date : | August 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Telavancin |
Drug: Telavancin
Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days
Other Names:
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Active Comparator: Vancomycin, nafcillin, oxacillin, or cloxacillin
Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously
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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. |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062647
United States, Georgia | |
Wellstar Infectious Disease | |
Marietta, Georgia, United States, 30060 |
Principal Investigator: | G. Ralph Corey, MD | Duke University |
Responsible Party: | Steven L. Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc. |
ClinicalTrials.gov Identifier: | NCT00062647 |
Other Study ID Numbers: |
I6424-203a |
First Posted: | June 12, 2003 Key Record Dates |
Results First Posted: | March 22, 2011 |
Last Update Posted: | January 16, 2019 |
Last Verified: | January 2019 |
Bacterial Infections Bacteremia Gram-Positive Bacterial Infections Bacterial Infections and Mycoses Infections Sepsis Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Vancomycin Cloxacillin Oxacillin Telavancin Nafcillin Anti-Bacterial Agents Anti-Infective Agents |