Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2006-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gram-Positive Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Telavancin

Group Type EXPERIMENTAL

Telavancin

Intervention Type DRUG

Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days

Vancomycin, nafcillin, oxacillin, or cloxacillin

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

Group Type ACTIVE_COMPARATOR

Vancomycin, nafcillin, oxacillin, or cloxacillin

Intervention Type DRUG

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.

Interventions

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Telavancin

Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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TD-6424 VIBATIV

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No