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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00665327 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
|---|---|
| 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
|
| 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
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 78 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Medical Affairs Therapeutic Area Head ) |
| Study ID Numbers: | 10872 |
| Study First Received: | April 18, 2008 |
| Last Updated: | June 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00665327 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Community Acquired Pneumonia Pneumonia, CAP |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Ofloxacin Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents Pharmacologic Actions Anti-Bacterial Agents |
Respiratory Tract Diseases Respiratory Tract Infections Moxifloxacin Lung Diseases Therapeutic Uses Pneumonia Nucleic Acid Synthesis Inhibitors |