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| ID | Type | Description | Link |
|---|---|---|---|
| ASSIST-1 |
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This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment), and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).
Primary Objective:
The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure (TOC) visit (7 to 14 days after the end of treatment).
Secondary Objectives:
The secondary objectives of this study are to compare iclaprim with linezolid regarding:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous iclaprim or intravenous linezolid | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate (the ratio of number of clinically cured patients to the total number of patients in the population) at 7 to 14 days after the end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological eradication rate at 7-14 days after end of therapy. | ||
| Safety evaluations conducted during the study |
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Inclusion Criteria -Diagnosis of an infection consistent with complicated skin and skin structure infection due to a gram positive pathogen.
Exclusion Criteria: - Known or suspected hypersensitivity to any study medication or other related anti-infective medication - Any known or suspected condition or concurrent treatment contraindicated by the prescribing information - Previous enrollment in this study - Treatment with any investigational drug within 30 days before enrollment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| e-Study Site | National City | California | 91950 | United States | ||
| VA Medical Center |
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| Label | URL |
|---|---|
| ARPIDA AG corporate website | View source |
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| ID | Term |
|---|---|
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
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| Boise |
| Idaho |
| 83702 |
| United States |
| Infectious Disease of Indiana | Indianapolis | Indiana | 46260 | United States |
| Judith Stone. M.D. | Cumberland | Maryland | 21502 | United States |
| ID Clinical Research, Ltd. | Toledo | Ohio | 43608 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |