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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novexel Inc
• Treatments: Linezolid; Streptogramin A

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