Phase 2 N=60 Randomized Quadruple-blind Treatment

Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Gram-Positive Bacterial Infections

Bottom Line

View on ClinicalTrials.gov: NCT00062647 ↗

Enrolled (actual)

Serious AEs

29.3%

Results posted

Mar 2011

Primary outcome: 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 — 7; 8; 1; 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Telavancin (Drug); Vancomycin, nafcillin, oxacillin, or cloxacillin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cumberland Pharmaceuticals
Primary completion: Aug 2006

Outcome Measures

Outcome	Result	p-value
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	7; 8; 1; 1	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00062647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.