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Released by he FDA from this Post-Marketing Commitment
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The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIBATIV treated pregnant women | Women treated with telavancin (any dose or duration) during pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIBATIV | Drug | Observational |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy | Once per trimester, 6-7 months gestation, and within 4 weeks after the estimated due date |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of fetal exposure to VIBATIV on pregnancy outcomes | Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age. | |
| Fetal/neonatal outcomes | Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age. |
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Inclusion Criteria:
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Women exposed to VIBATIV during pregnancy and where outcome of pregnancy is unknown at time of enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Adam Haberle, PhD | Cumberland Pharmaceuticals, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cumberland Pharmaceuticals Inc. | Nashville | Tennessee | 37203 | United States |
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| ID | Term |
|---|---|
| C487637 | telavancin |
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| Infant development and milestones through 12 months of age | Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age. |