CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,035 enrolled
Drug / intervention
Telavancin +1 moredrug
Likely dose
Telavancin 10 mg/kg/day IV for up to 14 days; Vancomycin 1 g IV every 12 hours for up to 14 daysAI-extracted
Key inclusion· 2
  • ✓Diagnosis of complicated skin and skin structure infection with MRSA (suspected or confirmed) as major cause, including: major abscess requiring drainage, infected burn, deep/extensive cellulitis, infected ulcer, or wound infection
  • ✓Expected to require at least 7 days of intravenous antibiotic treatment
Key exclusion· 3
  • ✕Received more than 24 hours of potentially effective systemic antibiotic therapy (IV/IM or PO)
  • ✕Burns involving >20% body surface area or third-degree/full-thickness burns
  • ✕Diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis

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

Search/NCT00107978
NCT00107978Phase 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 Apr 12, 2005·Updated Jan 16, 2019

In Brief

A Phase 3 clinical trial evaluating Telavancin and Vancomycin for Staphylococcal Skin Infection. Completed, enrolled 1,035 participants across 1 site.

Detailed Summary

Study 0018 (NCT00107978) 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 PostedApr 12, 2005
Enrollment StartFeb 1, 2005
Primary CompletionMay 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 21.2 years ago

Interventions

Telavancindrug

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

Vancomycindrug

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