NCT01283581

A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections

A Phase 2 Exploratory Study of Objective Endpoints in Subjects With Acute Bacterial Skin and Skin Structure Infections Treated With Delafloxacin, Vancomycin, or Linezolid

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials

Conditions

• Skin and Subcutaneous Tissue Bacterial Infections

Interventions

Type	Name	Description
DRUG	Delafloxacin	300mg IV every 12 hours for 5-14 days
DRUG	Linezolid	600mg IV every 12 hours for 5-14 days
DRUG	Vancomycin	15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-01-26
• Last updated: 2019-10-16
• Results posted: 2013-10-29

Locations

31 sites across 1 country: United States