Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Cumberland Pharmaceuticals60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Gram-Positive Bacterial Infections

Interventions

TelavancinDRUG

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

Vancomycin, nafcillin, oxacillin, or cloxacillinDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Wellstar Infectious Disease

Marietta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks after start of treatment

Data from ClinicalTrials.gov

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