Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)

Completed · Phase 3

Conditions studied: Complicated Skin and Skin Structure Infection

In brief

This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment), and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).

Key facts

Study ID

NCT00299520

Run by

Arpida AG

Starts

2005-06-01

Expected to finish

2006-07-01

Last updated by the study team

2008-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• e-Study Site — National City, California, United States
• VA Medical Center — Boise, Idaho, United States
• Infectious Disease of Indiana — Indianapolis, Indiana, United States
• Judith Stone. M.D. — Cumberland, Maryland, United States
• ID Clinical Research, Ltd. — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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