|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00828971 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
| Arm 1: Experimental |
Drug: Avelox (Moxifloxacin, BAY12-8039)
Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days.
|
| 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
|
Eligibility| 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:
Contacts and Locations| 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, 98158 | |
| Not yet recruiting | |
| Ferrara, Italy, 44100 | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
| Study ID Numbers: | 12670, 2007-001491-36, MERAK |
| Study First Received: | January 23, 2009 |
| Last Updated: | September 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00828971 History of Changes |
| Health Authority: | Italy: The Italian Medicines Agency; United States: Food and Drug Administration |
|
Complicated skin and skin structure infections cSSSI |
|
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 |