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 (ATLAS I)

Phase 3

Completed

• Conditions: Complicated Gram positive Skin and Skin Structure Infections; Skin - Dermatological conditions

• Registration Number: ACTRN12605000323628
• Lead Sponsor: Theravance, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Diagnosis of complicated skin and skin structure infections with MRSA either suspected or confirmed as the major cause of the infection:Require at least 7 days of IV antibiotic treatment.

Exclusion Criteria

More than 24 hours of prior therapy or is a treatment failure. Pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response[At the end of therapy]

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability[Baseline, q 3 d, End of Therapy, and Test of cure];Duration of treatment[End of therapy];Time to resolution of fever[From baseline through Test of cure visit.];Total signs and symptoms score[On Days 1-4];Change in size of primary infection site[From baseline on Days 2-4, at end of therapy and at the test of cure visit 7-14 days following the end of treatment.]