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multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.
multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.
The main criteria for evaluation will be:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin | Drug | |||
| Vancomycin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rate at TOC |
| Measure | Description | Time Frame |
|---|---|---|
| difference between clinical response rates at EOT | ||
| microbiological eradication rates |
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Inclusion Criteria:
Informed consent obtained
Male or female ≥18 years of age
If female of childbearing potential, willing to practice reliable birth control measures and documented negative pregnancy test
Skin and skin structure infections of a complicated nature that require intravenous antibiotic treatment
Gram-positive infecting pathogen
Physician determination that vancomycin would be the initial treatment of choice
At least three clinical signs and symptoms associated with the cSSSI:
Creatinine clearance of ≥50 mL/min.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Nathan, D.O. | Idaho Falls Infectious Diseases, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Idaho Falls Infectious Diseases, PLLC | Idaho Falls | Idaho | 83404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18662172 | Derived | Katz DE, Lindfield KC, Steenbergen JN, Benziger DP, Blackerby KJ, Knapp AG, Martone WJ. A pilot study of high-dose short duration daptomycin for the treatment of patients with complicated skin and skin structure infections caused by gram-positive bacteria. Int J Clin Pract. 2008 Sep;62(9):1455-64. doi: 10.1111/j.1742-1241.2008.01854.x. Epub 2008 Jul 25. |
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| ID | Term |
|---|---|
| D018461 | Soft Tissue Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
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| D008055 |
| Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |