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Sponsored by: |
Bayer |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00431678 |
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.
Condition | Intervention | Phase |
---|---|---|
Community-Acquired Pneumonia |
Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Comparator |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multinational, Prospective, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Sequential Intravenous/Oral Moxifloxacin in Comparison to Intravenous Levofloxacin Plus Intravenous Ceftriaxone Followed by Oral Levofloxacin, in the Treatment of Patients With Severe Community-Acquired Pneumonia |
Enrollment: | 752 |
Study Start Date: | January 2004 |
Study Completion Date: | July 2005 |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental
N/A
|
Drug: Avelox (Moxifloxacin, BAY12-8039)
Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039)
|
Arm 2: Active Comparator
N/A
|
Drug: Comparator
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).
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | ( Bayer Healthcare AG, Therapeutic Area Head ) |
Study ID Numbers: | 11215 |
Study First Received: | February 5, 2007 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00431678 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
Respiratory Tract Infections Respiratory Tract Diseases Moxifloxacin Lung Diseases |
Ofloxacin Ceftriaxone Pneumonia |
Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Infective Agents, Urinary |
Enzyme Inhibitors Renal Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |