Sequential therapy with intravenous to oral moxifloxacin, was tested at 69 study centres in 17 countries to determine if this treatment regimen is safe and effective in treating hospitalized adult patients with community-acquired pneumonia. 748 patients were participated in the study over an 18 months period. Individual patient involvement in the study was approximately 4-6 weeks. Moxifloxacin was compared to a combination treatment regimen of high dose intravenous ceftriaxone plus high dose intravenous levofloxacin followed by high dose oral levofloxacin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
738
Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039)
Intravenous combination therapy of levofloxacin 500 mg twice daily and ceftriaxone (2 g once a day) followed by oral levofloxacin (500 mg twice a day for 7 to 14 days).
Unnamed facility
Vicente López, Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Buenos Aires F.D., Argentina
Unnamed facility
Buenos Aires, Buenos Aires F.D., Argentina
Unnamed facility
Buenos Aires, Buenos Aires F.D., Argentina
Unnamed facility
Buenos Aires, Buenos Aires F.D., Argentina
Clinical response
Time frame: 5 to 7 days after last dose of study medication
Clinical and bacteriological response
Time frame: At the day of switch from intravenous to oral therapy
Clinical and bacteriological response on treatment
Time frame: At day 3 to 5
Clinical and bacteriological response
Time frame: At the end of treatment
Bacteriological response
Time frame: 5-7 days after end of treatment
Mortality attributable to pneumonia
Time frame: 5-7 days after end of treatment
Clinical and bacteriological response
Time frame: At days 21 to 28 after end of treatment
Symptoms course of community-acquired pneumonia
Time frame: at defined visits
Adverse Event Collection
Time frame: all visits
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Unnamed facility
Bruxelles - Brussel, Belgium
Unnamed facility
Bruxelles - Brussel, Belgium
Unnamed facility
Leuven, Belgium
Unnamed facility
Liège, Belgium
Unnamed facility
Namur, Belgium
...and 85 more locations