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

Acute Bacterial Skin and Skin Structure Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949130
• Other study ID #: NXL103/2002
• Status: Completed
• Phase: Phase 2
• First received: July 29, 2009
• Last updated: March 17, 2010
• Start date: November 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Novexel Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bacterial Skin and Skin Structure Infections
• Infection

Intervention

Drug:
• NXL103
BID for 7-14 days
• Linezolid
BID for 7-14 days

Locations

Country	Name	City	State
Guatemala	Military Health Center	Guatemala
Guatemala	Roosevelt Hospital	Guatemala
Guatemala	UNICAR	Guatemala
Guatemala	Private Hospital	Quetzaltenango
United States	Mercury Street Medical Group	Butte	Montana
United States	Sharp Chula Vista Research Office	Chula Vista	California
United States	Southeast Regional Research Group	Columbus	Georgia
United States	Fountain Valley Regional Hospital and Medical Center	Fountain Valley	California
United States	Idaho Falls Infectious Diseases	Idaho Falls	Idaho
United States	Sharp Grossmont Research Office	LaMesa	California
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Infectious Diseaes MPLS-LTD	Minneapolis	Minnesota
United States	Tri-City Oceanside Office	Oceanside	California
United States	Southeast Regional Research Group	Savannah	Georgia
United States	RPS Infectious Diseases	West Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novexel Inc

Countries where clinical trial is conducted

United States,  Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response at the early follow-up visit (Test of cure)		7 days post therapy	No
Secondary	Clinical outcome at the late follow-up visit		21 days post therapy	No
Secondary	Clinical outcome at the end of treatment		10-14 days therapy	No
Secondary	Microbiological outcome at the early follow-up visit (Test of cure)		7 days post-therapy	No
Secondary	Safety Profiles (safety and tolerability)		throughout the study	No
Secondary	Population pharmacokinetic profile of the experimental study drug		Day 1-5 while on study drug	No