VIBATIV Pregnancy Registry
Information source: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy
Intervention: telavancin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Theravance Biopharma Antibiotics, Inc. Official(s) and/or principal investigator(s): Principal Investigator, Study Director, Affiliation: Theravance Biopharma Antibiotics, Inc.
Overall contact: Theravance Biopharma Antibiotics, Inc. Medical Information, Phone: 1-855-633-8479
Summary
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.
Clinical Details
Official title: VIBATIV (Telavancin Hydrochloride) Pregnancy Exposure Registry
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy
Secondary outcome: Effect of fetal exposure to VIBATIV on pregnancy outcomesFetal/neonatal outcomes Infant development and milestones through 12 months of age
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Female patients who were exposed to VIBATIV at any time during pregnancy
- Outcome of pregnancy is unknown at the time of enrollment
Locations and Contacts
Theravance Biopharma Antibiotics, Inc. Medical Information, Phone: 1-855-633-8479
Theravance Biopharma Antibiotics, Inc., South San Francisco, California 94080, United States; Recruiting
Additional Information
Starting date: November 2009
Last updated: January 2, 2015
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