CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 862 enrolled
Drug / intervention
Telavancin +1 moredrug
Likely dose
Telavancin 10 mg/kg/day IV for up to 14 days; Vancomycin 1 Gm IV q 12 hrs for up to 14 daysAI-extracted
Key inclusion· 2
  • ✓Diagnosis of complicated skin and skin structure infection with MRSA (suspected or confirmed) including: major abscess requiring surgical drainage, infected burn, deep/extensive cellulitis, infected ulcer, or wound infection
  • ✓Expected to require at least 7 days of intravenous antibiotic treatment
Key exclusion· 4
  • ✕More than 24 hours of prior potentially effective systemic antibiotic therapy (IV, IM, or PO) before randomization
  • ✕Burns involving >20% body surface area or third-degree/full-thickness burns
  • ✕Diabetic foot ulcers or ischemic ulcers/wounds
  • ✕Necrotizing fasciitis, gas gangrene, or mediastinitis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00091819
NCT00091819Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections With a Focus on Patients With Infections Due to Methicillin-resistant Staphylococcus Aureus

Cumberland Pharmaceuticals·interventional·Posted Sep 21, 2004·Updated Jan 16, 2019

In Brief

A Phase 3 clinical trial evaluating Telavancin and Vancomycin for Staphylococcal Skin Infection. Completed, enrolled 862 participants across 1 site.

Detailed Summary

Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStaphylococcal Skin Infection
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2004
Enrollment StartJan 1, 2005
Primary CompletionJun 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 21.8 years ago

Interventions

Telavancindrug

Telavancin 10 mg/kg/day, IV for up to 14 days.

Vancomycindrug

Vancomycin 1 Gm IV q 12 hrs for up to 14 days.