Comparative Study of NXL103 versus Linezolid in adults with acute bacterial skin and skin structure infections (ABSSSI)

Study identifier:NXL103/2002

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A multicenter,investigator-blinded,randomized, comparative study to evaluate the efficacy and safety of oral NXL103 versus oral linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI)

Medical condition

Acute bacterial skin and skin structure infections

Phase

Phase 2

Healthy volunteers

Study drug

NXL103, Linezolid

Sex

All

Actual Enrollment

180

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 01 Nov 2009

Primary Completion Date: 01 Apr 2010

Study Completion Date: 01 Apr 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2011 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

LaMesa, CA, United States, 91942

Location

Research Site

Minneapolis, MN, United States, 55415

Location

Research Site

Fountain Valley, CA, United States, 92708

Location

Research Site

Oceanside, CA, United States, 92056

Location

Research Site

Savannah, GA, United States, 31406

Location

Research Site

Chula Vista, CA, United States, 91911

Location

Research Site

Butte, MT, United States, 59701

Location

Research Site

Columbus, GA, United States, 31904

Arms	Assigned Interventions
Experimental: NXL103 BID for 10-14 days orally	Drug: NXL103 BID for 10-14 days
Active Comparator: Linezolid BID for 10-14 days orally	Drug: Linezolid BID for 10-14 days

"There is no result for the study"

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Michael Kuligowski

484-362-2663

michael.kuligowski@novexel.com

Investigators

Principal Investigator

Dr. William O'Riordan

EStudy Site

Comparative Study of NXL103 versus Linezolid in adults with acute bacterial skin and skin structure infections (ABSSSI)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator