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

Completed · Phase 2

Conditions studied: Acute Bacterial Skin and Skin Structure Infections

In brief

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

Key facts

Study ID

NCT00949130

Run by

Novexel Inc

People needed

180

Starts

2009-11-01

Expected to finish

2010-03-01

Last updated by the study team

2010-03-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with acute bacterial skin and skin structure infection (ABSSSI) with at least 3 signs or symptoms

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.