The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin is as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the treatment of complicated skin and skin structure infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.
IV Amoxicilline/clavulanic acid 2000/200 mg TID followed by PO amoxicilline/clavulanate 875/125 mg TID for a total of 7 to 21 days
Unnamed facility
Bagno Di Ripoli, Firenze, Italy
Unnamed facility
Bari, Italy
Unnamed facility
Bergamo, Italy
Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]).
Time frame: Test-of-Cure visit [TOC].
Clinical response assessed by the investigator on treatment Day 3-5
Time frame: Day 3-5
Clinical response assessed by the investigator at the end-of-therapy (EOT).
Time frame: At the end-of-therapy (EOT)
Time to switch from oral to IV therapy
Time frame: Day of switch from oral to IV therapy
Bacteriological response (for microbiologically valid population) at the EOT and TOC
Time frame: At the end-of-therapy (EOT), Test-of-Cure visit [TOC].
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Unnamed facility
Bologna, Italy
Unnamed facility
Brescia, Italy
Unnamed facility
Ferrara, Italy
Unnamed facility
Florence, Italy
Unnamed facility
Foggia, Italy
Unnamed facility
Genova, Italy
Unnamed facility
Mantova, Italy
...and 12 more locations