The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs. established treatment of acute bacterial infection in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Sharp Chula Vista Research Office
Chula Vista, California, United States
Fountain Valley Regional Hospital and Medical Center
Fountain Valley, California, United States
Clinical response at the early follow-up visit (Test of cure)
Time frame: 7 days post therapy
Clinical outcome at the late follow-up visit
Time frame: 21 days post therapy
Clinical outcome at the end of treatment
Time frame: 10-14 days therapy
Microbiological outcome at the early follow-up visit (Test of cure)
Time frame: 7 days post-therapy
Safety Profiles (safety and tolerability)
Time frame: throughout the study
Population pharmacokinetic profile of the experimental study drug
Time frame: Day 1-5 while on study drug
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