The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired pneumonia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
IV therapy: every 24 hours, patients will be administered a 400 mg moxifloxacin infusion over 60 minutes. Oral therapy: patients will be administered a single moxifloxacin 400 mg tablet, every 24 hours
IV therapy: every 24 hours patients will be administered a 2 g ceftriaxone infusion over 30 minutes. Following the infusion with ceftriaxone, patients will be administered a 500 mg azithromycin infusion over 180 minutes.Oral therapy: every 8 hours patients will be administered a 1000 mg amoxicillin/clavulanic acid tablet. Every 12 hours patients will be administered a 500 mg clarithromycin tablet.
Unnamed facility
Lungro, Cosenza, Italy
Unnamed facility
San Cesario di Lecce, Lecce, Italy
Unnamed facility
Fossombrone, Pesaro e Urbino, Italy
Clinical response 20 days after completion of study treatment (Test-of-Cure visit)
Time frame: 20 days after last dose of study drug (TOC Visit)
Clinical and bacteriological response on the day of switch from IV to oral therapy
Time frame: Day of switch from IV to oral therapy
Clinical and bacteriological response on treatment Day 3-5 (if the day of switch is different from Day 3, 4 or 5)
Time frame: Day 3-5
Bacteriological response at TOC
Time frame: 20 days after last dose of study drug
Clinical and bacteriological response at the end of treatment
Time frame: Day 7-14 after first dose of study drug
Mortality attributable to pneumonia at the Test-of-Cure visit
Time frame: 20 days after last dose of study drug
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Unnamed facility
Pregiato Di Cava Dei Tirreni, Salerno, Italy
Unnamed facility
Vittorio Veneto, Treviso, Italy
Unnamed facility
Ascoli Piceno, Italy
Unnamed facility
Benevento, Italy
Unnamed facility
Brescia, Italy
Unnamed facility
Catania, Italy
Unnamed facility
Chieti, Italy
...and 13 more locations