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

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ClinicalTrials.gov Identifier: NCT00949130
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : March 18, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Acute Bacterial Skin and Skin Structure Infections Drug: NXL103 Drug: Linezolid Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)
Study Start Date : November 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Clinical response at the early follow-up visit (Test of cure) [ Time Frame: 7 days post therapy ]

Secondary Outcome Measures :
  1. Clinical outcome at the late follow-up visit [ Time Frame: 21 days post therapy ]
  2. Clinical outcome at the end of treatment [ Time Frame: 10-14 days therapy ]
  3. Microbiological outcome at the early follow-up visit (Test of cure) [ Time Frame: 7 days post-therapy ]
  4. Safety Profiles (safety and tolerability) [ Time Frame: throughout the study ]
  5. Population pharmacokinetic profile of the experimental study drug [ Time Frame: Day 1-5 while on study drug ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Roosevelt Hospital
Guatemala, Guatemala, 1011
UNICAR
Guatemala, Guatemala, 1011
Military Health Center
Guatemala, Guatemala
Private Hospital
Quetzaltenango, Guatemala
Sponsors and Collaborators
Novexel Inc
Investigators
Study Director: Michael Kuligowski, MD Novexel Inc
More Information

Responsible Party: Dr. Michael Kuligowski, Director of Clinical Research, Novexel Inc
ClinicalTrials.gov Identifier: NCT00949130     History of Changes
Other Study ID Numbers: NXL103/2002
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: March 18, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Infection
Communicable Diseases
Linezolid
Streptogramin A
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action