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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00828971 |
The purpose of this study is to assess if a therapy with intravenous and oral moxifloxacin is as effective as a therapy with intravenous and oral amoxicilline/clavulanate in the treatment of complicated skin and skin structure infection.
Condition | Intervention | Phase |
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Infectious Diseases |
Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Amoxicilline/clavulanic |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Open Label, Active Comparator, Multicenter, National Trial to Compare the Efficacy and Safety of Sequential IV/PO Moxifloxacin 400 mg Once Daily Versus IV Amoxicillin/Clavulanate 2,0/0,2 g Every 8 Hours Followed by Oral Amoxicillin/Clavulanate 875/125 mg Every 8 Hours in the Treatment of Adult Subjects With Complicated Skin and Skin Structure Infections |
Estimated Enrollment: | 868 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Avelox (Moxifloxacin, BAY12-8039)
Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.
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Arm 2: Active Comparator |
Drug: Amoxicilline/clavulanic
IV Amoxicilline/clavulanic acid 2000/200 mg TID followed by PO amoxicilline/clavulanate 875/125 mg TID for a total of 7 to 21 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Men or women of age ≥ 18 years with a diagnosis of bacterial skin and skin structure infection that requires
Complicated by at least one of the following criteria:
Diagnosis of one of the following skin and skin structure infections:
Infected ischemic ulcers with at least one of the following conditions:
Presence of at least 3 of the following local signs and symptoms
fever defined as body temperature
Exclusion Criteria:
The following skin and skin structure infections:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Italy | |
Not yet recruiting | |
Bologna, Italy, 40138 | |
Not yet recruiting | |
Torino, Italy, 10149 | |
Recruiting | |
Genova, Italy, 16132 | |
Not yet recruiting | |
Varese, Italy, 21100 | |
Not yet recruiting | |
Brescia, Italy, 25123 | |
Not yet recruiting | |
Mantova, Italy, 46100 | |
Not yet recruiting | |
Bergamo, Italy, 24128 | |
Not yet recruiting | |
Reggio Emilia, Italy, 42100 | |
Not yet recruiting | |
Udine, Italy, 33100 | |
Not yet recruiting | |
Verona, Italy, 37126 | |
Not yet recruiting | |
Padova, Italy, 35128 | |
Not yet recruiting | |
Rimini, Italy, 47900 | |
Recruiting | |
Napoli, Italy, 80131 | |
Not yet recruiting | |
Roma, Italy, 00149 | |
Not yet recruiting | |
Bari, Italy, 70124 | |
Not yet recruiting | |
Firenze, Italy, 50126 | |
Not yet recruiting | |
Roma, Italy, 00168 | |
Recruiting | |
Firenze, Italy, 50139 | |
Not yet recruiting | |
Perugia, Italy, 06156 | |
Not yet recruiting | |
Foggia, Italy, 71100 | |
Not yet recruiting | |
Messina, Italy, 98165 | |
Not yet recruiting | |
Ferrara, Italy, 44100 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
Study ID Numbers: | 12670, 2007-001491-36, MERAK |
Study First Received: | January 23, 2009 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00828971 History of Changes |
Health Authority: | Italy: The Italian Medicines Agency |
Complicated skin and skin structure infections cSSSI |
Anti-Infective Agents Anti-Bacterial Agents Amoxicillin Moxifloxacin |
Clavulanic Acid Clavulanic Acids Amoxicillin-Potassium Clavulanate Combination |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases Amoxicillin Molecular Mechanisms of Pharmacological Action Moxifloxacin |
Therapeutic Uses Clavulanic Acid Enzyme Inhibitors Amoxicillin-Potassium Clavulanate Combination Infection Pharmacologic Actions |