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| Name | Class |
|---|---|
| Christchurch Clinical Studies Trust Ltd | INDUSTRY |
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The study will determine the magnitude and duration (time to resolution i.e., returning to normal ranges) of elevations in the following coagulation test results after a single 1200 mg dose of oritavancin: Prothrombin Time/International Normalized Ratio (PT/INR), Activated clotting time (ACT), Activated Partial Thromboplastin Time (APTT), Chromogenic Factor Xa Assay, D-dimer, Silica Clot Time and Dilute Russell's Viper Venom Time (DRVVT).
Oritavancin has been approved in the United States for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms.
Antibiotics of this class (lipoglycopeptide and lipopeptide antibiotics) artificially prolong phospholipid-dependent coagulation tests such as prothrombin time (PT) and activated partial thromboplastin time (aPTT) by binding to and preventing the action of the phospholipid reagents needed to activate coagulation.
Because precipitation of oritavancin has been shown to occur in human plasma at concentrations as low as 50 μg/mL in vitro, a relevant approach to further elucidate the full range of effects of oritavancin plasma concentrations on coagulation testing would be to conduct a clinical study in healthy volunteers in which coagulation tests are monitored following a single 3 hour infusion of 1200 mg oritavancin. The data from this study will help inform physicians about how to manage patients who require coagulation monitoring in the setting of treatment with oritavancin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oritavancin | Experimental | Subject will receive a single oritavancin dose of 1200 mg in 1000 mL of D5W administered as a constant rate IV infusion over 3 hours via a single dedicated peripheral venous line. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oritavancin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to resolution of elevations in coagulation test results | Time to resolution of elevations in PT/INR, ACT, APTT, Chromogenic Factor Xa level, D-dimer, Silica Clot Time and DRVVT value will be descriptively summarized for each assay. If appropriate, two-sided 95% confidence interval for the median time will also be provided. | up to 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in coagulation test results | Changes from baseline in PT/INR, ACT, APTT, Chromogenic Factor Xa level, D-dimer, Silica Clot Time and DRVVT value will be summarized for each assay at each post-baseline time point. Two-sided 95% confidence interval for the changes will also be provided. The number and percentage of subjects having coagulation test values outside normal ranges will also be summarized for each assay at each post-baseline time point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Information | Melinta Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christchurch | 8011 | New Zealand |
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| ID | Term |
|---|---|
| C100708 | oritavancin |
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| up to 120 hours |