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The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMX-30063 | Experimental | 3 arms of PMX-300063 |
|
| Daptomycin. | Active Comparator | Daptomycin will be administered according to the approved product monograph information for ABSSSI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin | Drug | Active Comparator: Daptomycin. |
| |
| PMX-30063-investigational drug |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI). | The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI). The primary measure of efficacy will be bacteriologic eradication at end of treatment of S. aureus (either Methicillin-susceptible (MSSA) or Methicillin-resistant (MRSA)) in subjects with ABSSSI and having S. aureus isolated from an appropriate infection site prior to randomization. The secondary objectives are clinical responses, safety and pharokinetics of PMX-300063. | Eradication at end of treatment (day 7/8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton | Ontario | L8N 4A6 | Canada | |||
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| Drug |
Experimental: PMX-30063 |
|
| Chicoutimi |
| Quebec |
| G7H 5H6 |
| Canada |
| Greenfield Park | Quebec | J4V 2H1 | Canada |
| Québec | Quebec | G1V 4X7 | Canada |
| Sherbrooke | Quebec | J1H 5N4 | Canada |
| Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| 11 Sites | Multiple | Russia |
| 5 Sites | Multiple | Ukraine |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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