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

March 17, 2010 updated by: Novexel Inc

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical response at the early follow-up visit (Test of cure)
Time Frame: 7 days post therapy
7 days post therapy

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novexel Inc

Investigators

  • Study Director: Michael Kuligowski, MD, Novexel Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (ESTIMATE)

July 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2010

Last Update Submitted That Met QC Criteria

March 17, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NXL103/2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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