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Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE)

Cumberland Pharmaceuticals logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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