Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Gram-Positive Bacterial Infections Clinical Trial

— ASSURE  

Official title:

A Phase 2, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Televancin (TD-6424) for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062647
• Other study ID #: I6424-203a
• Status: Completed
• Phase: Phase 2
• Start date: August 2003
• Est. completion date: August 2006

Study information

• Verified date: January 2019
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Bacterial Infections
• Gram-Positive Bacterial Infections

Intervention

Drug:
• Telavancin
Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days
• 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.

Locations

Country	Name	City	State
United States	Wellstar Infectious Disease	Marietta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 weeks after start of treatment