This is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in Italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
293
Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days
Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days
Unnamed facility
San Benedetto del Tronto, Ascoli Piceno, Italy
Number of Participants With Response (Per-protocol Population)
Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"
Time frame: At 'Test-of-Cure', Day 1-3 after treatment
Number of Participants With Response (Intent-to-treat Population)
Number of patients in the population who received at least one dose of study medication whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"
Time frame: At 'Test-of-Cure', Day 1-3 after treatment
Number of Participants With Response (Per-protocol Population)
Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 24-30 days after treatment was assessed by the investigator as "continued clinical cure"
Time frame: End of Follow-up, Day 24-30 after treatment
Number of Participants With Response (Microbiologically Valid Patients)
Bacteriological Efficacy Rate at the 'Test-of-Cure' visit, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.
Time frame: At 'Test-of-Cure', Day 1-3 after treatment
Number of Participants With Response (Microbiologically Valid Patients)
Bacteriological Efficacy Rate at the End of Follow-up period, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.
Time frame: End of Follow-up, Day 24-30 after treatment
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Unnamed facility
Esine, Brescia, Italy
Unnamed facility
Lamezia Terme, Catanzaro, Italy
Unnamed facility
Cesena, Forlì, Italy
Unnamed facility
Sestri Ponente, Genova, Italy
Unnamed facility
Monza, Monza-Brianza, Italy
Unnamed facility
Comiso, Ragusa, Italy
Unnamed facility
Bari, Italy
Unnamed facility
Benevento, Italy
Unnamed facility
Bergamo, Italy
...and 24 more locations