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

This study has been completed.
Sponsor:
Information provided by:
Novexel Inc
ClinicalTrials.gov Identifier:
NCT00949130
First received: July 29, 2009
Last updated: March 17, 2010
Last verified: March 2010
  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 2

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:


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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Roosevelt Hospital
Guatemala, Guatemala, 1011
Military Health Center
Guatemala, Guatemala
UNICAR
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 August 21, 2014