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

Novexel

Status and phase: Completed; Phase 2

Conditions: Acute Bacterial Skin and Skin Structure Infections

Treatments: Drug: Linezolid; Drug: NXL103

Study type: Interventional

Funder types: Industry

Identifiers

NCT00949130

NXL103/2002

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

NXL103

Experimental group

Description:

BID for 7-14 days orally

Treatment:

Drug: NXL103

Linezolid

Active Comparator group

Description:

BID for 7-14 days orally

Treatment:

Drug: Linezolid