Acute Bacterial Skin and Skin Structure Infections
Conditions
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.
Interventions
DRUGLinezolid
BID for 7-14 days
DRUGNXL103
BID for 7-14 days
Sponsors
Novexel Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response at the early follow-up visit (Test of cure) | 7 days post therapy |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Guatemala, United States
Outcome results
None listed