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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00665327 |
This study compared the safety and efficacy of Avelox® vs. Levaquin® for the treatment of Community Acquired Pneumonia (CAP) in patients >= 65 years of age.
Condition | Intervention | Phase |
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Pneumonia |
Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Levofloxacin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study |
Official Title: | A Study of Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia |
Enrollment: | 400 |
Study Start Date: | November 2002 |
Study Completion Date: | April 2004 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin 400 mg IV QD for a minimum of two doses followed by moxifloxacin 400 mg PO QD for a total treatment duration of 7 to 14 days
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Arm 2: Active Comparator |
Drug: Levofloxacin
Levofloxacin 500 mg IV QD for a minimum of two doses followed by Levofloxacin 500 mg PO QD for a total treatment duration of 7 to 14 days. For patients who have a documented or calculated creatinine clearance of 20 - 49 ml/minute, the IV and PO dose of Levofloxacin will be a 500 mg loading dose followed by 250 mg QD for a total treatment duration of 7 to 14 days
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This study was to assess the safety of sequential intravenous (IV)/oral (PO) moxifloxacin (Avelox®) compared with sequential IV/PO levofloxacin (Levaquin®) in the treatment of elderly subjects (aged ≥ 65 years) with community-acquired pneumonia (CAP) who required initial IV therapy. This study also included an assessment of the clinical and bacteriologic effectiveness of both drugs.
Ages Eligible for Study: | 65 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 Corporation, Therapeutic Area Head ) |
Study ID Numbers: | 10872, SAFE CAP |
Study First Received: | April 18, 2008 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00665327 |
Health Authority: | United States: Food and Drug Administration |
Community Acquired Pneumonia Pneumonia, CAP |
Respiratory Tract Infections Respiratory Tract Diseases Moxifloxacin |
Lung Diseases Ofloxacin 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 |