VIBATIV Pregnancy Registry

Withdrawn

• Conditions: Pregnancy
• Interventions: Drug: VIBATIV

• Registration Number: NCT01130324
• Lead Sponsor: Cumberland Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Status Verified: 2020-10
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Female patients who were exposed to VIBATIV at any time during pregnancy
• Outcome of pregnancy is unknown at the time of enrollment

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VIBATIV treated pregnant women	VIBATIV	Women treated with telavancin (any dose or duration) during pregnancy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Cumberland Pharmaceuticals Inc.; 🇺🇸 Nashville, Tennessee, United States