Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
- Conditions
- Acute Bacterial Skin and Skin Structure Infections
- Interventions
- Drug: NXL103
- Registration Number
- NCT00949130
- Lead Sponsor
- Novexel Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- Diagnosed with acute bacterial skin and skin structure infection (ABSSSI) with at least 3 signs or symptoms
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NXL103 NXL103 BID for 7-14 days orally Linezolid Linezolid BID for 7-14 days orally
- Primary Outcome Measures
Name Time Method Clinical response at the early follow-up visit (Test of cure) 7 days post therapy
- Secondary Outcome Measures
Name Time Method Clinical outcome at the late follow-up visit 21 days post therapy Clinical outcome at the end of treatment 10-14 days therapy Microbiological outcome at the early follow-up visit (Test of cure) 7 days post-therapy Safety Profiles (safety and tolerability) throughout the study Population pharmacokinetic profile of the experimental study drug Day 1-5 while on study drug
Trial Locations
- Locations (14)
Fountain Valley Regional Hospital and Medical Center
🇺🇸Fountain Valley, California, United States
Idaho Falls Infectious Diseases
🇺🇸Idaho Falls, Idaho, United States
Mercury Street Medical Group
🇺🇸Butte, Montana, United States
UNICAR
🇬🇹Guatemala, Guatemala
Roosevelt Hospital
🇬🇹Guatemala, Guatemala
Military Health Center
🇬🇹Guatemala, Guatemala
Private Hospital
🇬🇹Quetzaltenango, Guatemala
Southeast Regional Research Group
🇺🇸Savannah, Georgia, United States
Tri-City Oceanside Office
🇺🇸Oceanside, California, United States
RPS Infectious Diseases
🇺🇸West Reading, Pennsylvania, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Infectious Diseaes MPLS-LTD
🇺🇸Minneapolis, Minnesota, United States
Sharp Chula Vista Research Office
🇺🇸Chula Vista, California, United States
Sharp Grossmont Research Office
🇺🇸LaMesa, California, United States