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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001491-36 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelox (Moxifloxacin, BAY12-8039) | Drug | Sequential IV/PO moxifloxacin 400/400 mg every 24 hours, for 7 to 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response up to 14-21 days after the completion of study drug therapy (Test-of-Cure visit [TOC]). | Test-of-Cure visit [TOC]. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response assessed by the investigator on treatment Day 3-5 | Day 3-5 | |
| Clinical response assessed by the investigator at the end-of-therapy (EOT). | At the end-of-therapy (EOT) | |
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Inclusion Criteria:
Written informed consent
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:
Presence of at least 3 of the following local signs and symptoms
Exclusion Criteria:
Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug).
The following skin and skin structure infections:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bagno Di Ripoli | Firenze | 50100 | Italy | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| Amoxicilline/clavulanic | Drug | 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 |
|
| Time to switch from oral to IV therapy |
| Day of switch from oral to IV therapy |
| Bacteriological response (for microbiologically valid population) at the EOT and TOC | At the end-of-therapy (EOT), Test-of-Cure visit [TOC]. |
| Bari |
| 70124 |
| Italy |
| Bergamo | 24128 | Italy |
| Bologna | 40138 | Italy |
| Brescia | 25123 | Italy |
| Ferrara | 44100 | Italy |
| Florence | 50139 | Italy |
| Foggia | 71100 | Italy |
| Genova | 16132 | Italy |
| Mantua | 46100 | Italy |
| Messina | 98158 | Italy |
| Naples | 80131 | Italy |
| Padova | 35128 | Italy |
| Perugia | 06122 | Italy |
| Reggio Emilia | 42100 | Italy |
| Rimini | 47900 | Italy |
| Roma | 00149 | Italy |
| Roma | 00168 | Italy |
| Torino | 10149 | Italy |
| Udine | 33100 | Italy |
| Varese | 21100 | Italy |
| Verona | 37126 | Italy |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
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