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:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

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

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

Contacts

Contact: Michael Kuligowski, MD

484-362-2663

Locations

United States, California
Sharp Grossmont Research Office	Recruiting
LaMesa, California, United States, 91942
Fountain Valley Regional Hospital and Medical Center	Active, not recruiting
Fountain Valley, California, United States, 92708
Tri-City Oceanside Office	Recruiting
Oceanside, California, United States, 92056
Sharp Chula Vista Research Office	Recruiting
Chula Vista, California, United States, 91911
United States, Georgia
Southeast Regional Research Group	Recruiting
Savannah, Georgia, United States, 31406
Southeast Regional Research Group	Recruiting
Columbus, Georgia, United States, 31904
United States, Idaho
Idaho Falls Infectious Diseases	Active, not recruiting
Idaho Falls, Idaho, United States, 83404
United States, Minnesota
Hennepin County Medical Center	Active, not recruiting
Minneapolis, Minnesota, United States, 55415
Infectious Diseaes MPLS-LTD	Active, not recruiting
Minneapolis, Minnesota, United States, 55422
United States, Montana
Mercury Street Medical Group	Recruiting
Butte, Montana, United States, 59701
United States, Pennsylvania
RPS Infectious Diseases	Active, not recruiting
West Reading, Pennsylvania, United States, 19611
Guatemala
Military Health Center	Active, not recruiting
Guatemala, Guatemala
UNICAR	Active, not recruiting
Guatemala, Guatemala, 1011
Private Hospital	Active, not recruiting
Quetzaltenango, Guatemala
Roosevelt Hospital	Active, not recruiting
Guatemala, Guatemala, 1011

Sponsors and Collaborators

Novexel Inc

Investigators

Study Director:

Michael Kuligowski, MD

Novexel Inc

More Information

No publications provided

Responsible Party:	Novexel Inc ( Dr. Michael Kuligowski, Director of Clinical Research )
Study ID Numbers:	NXL103/2002
Study First Received:	July 29, 2009
Last Updated:	November 3, 2009
ClinicalTrials.gov Identifier:	NCT00949130 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Infection
Linezolid
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 04, 2010