Comparative Study of NXL103 Versus Linezolid in Adults With Complicated Skin and Skin Structure Infections (cSSSI)

Condition(s) targeted: Complicated Skin and Skin Structure Infections

Intervention: NXL103 (Drug); Linezolid (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Novexel Inc

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

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 Complicated Skin and Skin Structure Infections (cSSSI)

Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosed with complicated skin and skin structure infection (cSSSI) with at least 3

signs or symptoms

Exclusion Criteria:

- Uncomplicated skin and skin structure infections

- cSSSI 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

Starting date: November 2009
Ending date: December 2010
Last updated: July 29, 2009