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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00431678 |
Purpose
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 |
|---|---|---|
|
Pneumonia |
Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Levofloxacin + Ceftriaxone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: Arm 1 |
Drug: Avelox (Moxifloxacin, BAY12-8039)
Sequential intravenous/oral (400/400 mg once daily for 7 to 14 days) of Avelox (Moxifloxacin, BAY12-8039)
|
| Active Comparator: Arm 2 |
Drug: Levofloxacin + Ceftriaxone
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).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 97 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00431678 History of Changes |
| Other Study ID Numbers: | 11215 |
| Study First Received: | February 5, 2007 |
| Last Updated: | June 29, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Community-acquired Pneumonia |
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Ceftriaxone Ofloxacin Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |