Status:
COMPLETED
Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Lead Sponsor:
Novexel Inc
Conditions:
Acute Bacterial Skin and Skin Structure Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Diagnosed with acute bacterial skin and skin structure infection (ABSSSI) with at least 3 signs or symptoms
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00949130
Start Date
November 1 2009
End Date
March 1 2010
Last Update
March 18 2010
Active Locations (15)
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1
Sharp Chula Vista Research Office
Chula Vista, California, United States, 91911
2
Fountain Valley Regional Hospital and Medical Center
Fountain Valley, California, United States, 92708
3
Sharp Grossmont Research Office
La Mesa, California, United States, 91942
4
Tri-City Oceanside Office
Oceanside, California, United States, 92056