VIBATIV Pregnancy Registry

Pregnancy Clinical Trial

Official title:

VIBATIV (Telavancin Hydrochloride) Pregnancy Exposure Registry

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01130324
• Other study ID #: 0113
• Status: Withdrawn
• Start date: November 2009
• Est. completion date: October 2020

Study information

• Verified date: October 2020
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Female patients who were exposed to VIBATIV at any time during pregnancy

• Outcome of pregnancy is unknown at the time of enrollment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• VIBATIV
Observational

Locations

Country	Name	City	State
United States	Cumberland Pharmaceuticals Inc.	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.
Secondary	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.
Secondary	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.