Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE)

Cumberland Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Gram-Positive Bacterial Infections

Treatments: Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin; Drug: Telavancin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00062647

I6424-203a

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Telavancin

Experimental group

Treatment:

Drug: Telavancin

Vancomycin, nafcillin, oxacillin, or cloxacillin

Active Comparator group

Description:

Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously

Treatment:

Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin