Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI) - Full Text View

Sponsor:	Novexel Inc
Information provided by:	Novexel Inc
ClinicalTrials.gov Identifier:	NCT00949130

Purpose

The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs. established treatment of acute bacterial infection in adults.

Condition	Intervention	Phase
Acute Bacterial Skin and Skin Structure Infections	Drug: NXL103 Drug: Linezolid	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

Drug Information available for: Linezolid

U.S. FDA Resources

Further study details as provided by Novexel Inc:

Primary Outcome Measures:

Clinical response at the early follow-up visit (Test of cure) [ Time Frame: 7 days post therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical outcome at the late follow-up visit [ Time Frame: 21 days post therapy ] [ Designated as safety issue: No ]
Clinical outcome at the end of treatment [ Time Frame: 10-14 days therapy ] [ Designated as safety issue: No ]
Microbiological outcome at the early follow-up visit (Test of cure) [ Time Frame: 7 days post-therapy ] [ Designated as safety issue: No ]
Safety Profiles (safety and tolerability) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Population pharmacokinetic profile of the experimental study drug [ Time Frame: Day 1-5 while on study drug ] [ Designated as safety issue: No ]

Enrollment:	180
Study Start Date:	November 2009
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NXL103 BID for 7-14 days orally	Drug: NXL103 BID for 7-14 days
Active Comparator: Linezolid BID for 7-14 days orally	Drug: Linezolid BID for 7-14 days

Eligibility

Criteria

Inclusion Criteria:

Diagnosed with acute bacterial skin and skin structure infection (ABSSSI) with at least 3 signs or symptoms

Exclusion Criteria:

Uncomplicated acute bacterial skin and skin structure infections
ABSSSI suspected or proven to be due to Gram negative and/or anaerobic pathogens
Pregnant or lactating women
Inadequately controlled diabetes mellitus
Inadequately controlled arterial hypertension
Moderate-to-severe renal impairment
Moderate-to-severe liver disease
Conditions associated with immunodeficiency
Known hypersensitivity or any contraindication for the use of any of the 2 study drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949130

Locations

United States, California
Sharp Chula Vista Research Office
Chula Vista, California, United States, 91911
Fountain Valley Regional Hospital and Medical Center
Fountain Valley, California, United States, 92708
Sharp Grossmont Research Office
LaMesa, California, United States, 91942
Tri-City Oceanside Office
Oceanside, California, United States, 92056
United States, Georgia
Southeast Regional Research Group
Columbus, Georgia, United States, 31904
Southeast Regional Research Group
Savannah, Georgia, United States, 31406
United States, Idaho
Idaho Falls Infectious Diseases
Idaho Falls, Idaho, United States, 83404
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Infectious Diseaes MPLS-LTD
Minneapolis, Minnesota, United States, 55422
United States, Montana
Mercury Street Medical Group
Butte, Montana, United States, 59701
United States, Pennsylvania
RPS Infectious Diseases
West Reading, Pennsylvania, United States, 19611
Guatemala
Military Health Center
Guatemala, Guatemala
UNICAR
Guatemala, Guatemala, 1011
Roosevelt Hospital
Guatemala, Guatemala, 1011
Private Hospital
Quetzaltenango, Guatemala

Sponsors and Collaborators

Novexel Inc

Investigators

Study Director:

Michael Kuligowski, MD

Novexel Inc

More Information

No publications provided

Responsible Party:	Dr. Michael Kuligowski, Director of Clinical Research, Novexel Inc
ClinicalTrials.gov Identifier:	NCT00949130 History of Changes
Other Study ID Numbers:	NXL103/2002
Study First Received:	July 29, 2009
Last Updated:	March 17, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012