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

Primary Purpose

Acute Bacterial Skin and Skin Structure Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NXL103
Linezolid
Sponsored by
Novexel Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bacterial Skin and Skin Structure Infections

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sharp Chula Vista Research Office
  • Fountain Valley Regional Hospital and Medical Center
  • Sharp Grossmont Research Office
  • Tri-City Oceanside Office
  • Southeast Regional Research Group
  • Southeast Regional Research Group
  • Idaho Falls Infectious Diseases
  • Hennepin County Medical Center
  • Infectious Diseaes MPLS-LTD
  • Mercury Street Medical Group
  • RPS Infectious Diseases
  • Roosevelt Hospital
  • UNICAR
  • Military Health Center
  • Private Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NXL103

Linezolid

Arm Description

BID for 7-14 days orally

BID for 7-14 days orally

Outcomes

Primary Outcome Measures

Clinical response at the early follow-up visit (Test of cure)

Secondary Outcome Measures

Clinical outcome at the late follow-up visit
Clinical outcome at the end of treatment
Microbiological outcome at the early follow-up visit (Test of cure)
Safety Profiles (safety and tolerability)
Population pharmacokinetic profile of the experimental study drug

Full Information

First Posted
July 29, 2009
Last Updated
March 17, 2010
Sponsor
Novexel Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00949130
Brief Title
Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
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 Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novexel Inc

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Skin and Skin Structure Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NXL103
Arm Type
Experimental
Arm Description
BID for 7-14 days orally
Arm Title
Linezolid
Arm Type
Active Comparator
Arm Description
BID for 7-14 days orally
Intervention Type
Drug
Intervention Name(s)
NXL103
Intervention Description
BID for 7-14 days
Intervention Type
Drug
Intervention Name(s)
Linezolid
Intervention Description
BID for 7-14 days
Primary Outcome Measure Information:
Title
Clinical response at the early follow-up visit (Test of cure)
Time Frame
7 days post therapy
Secondary Outcome Measure Information:
Title
Clinical outcome at the late follow-up visit
Time Frame
21 days post therapy
Title
Clinical outcome at the end of treatment
Time Frame
10-14 days therapy
Title
Microbiological outcome at the early follow-up visit (Test of cure)
Time Frame
7 days post-therapy
Title
Safety Profiles (safety and tolerability)
Time Frame
throughout the study
Title
Population pharmacokinetic profile of the experimental study drug
Time Frame
Day 1-5 while on study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kuligowski, MD
Organizational Affiliation
Novexel Inc
Official's Role
Study Director
Facility Information:
Facility Name
Sharp Chula Vista Research Office
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Fountain Valley Regional Hospital and Medical Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Sharp Grossmont Research Office
City
LaMesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Tri-City Oceanside Office
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Southeast Regional Research Group
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Southeast Regional Research Group
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Idaho Falls Infectious Diseases
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Infectious Diseaes MPLS-LTD
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mercury Street Medical Group
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
RPS Infectious Diseases
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Roosevelt Hospital
City
Guatemala
ZIP/Postal Code
1011
Country
Guatemala
Facility Name
UNICAR
City
Guatemala
ZIP/Postal Code
1011
Country
Guatemala
Facility Name
Military Health Center
City
Guatemala
Country
Guatemala
Facility Name
Private Hospital
City
Quetzaltenango
Country
Guatemala

12. IPD Sharing Statement

Learn more about this trial

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

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