VIBATIV Pregnancy Registry

VIBATIV (Telavancin Hydrochloride) Pregnancy Exposure Registry

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01130324

Enrollment

Registered

2010-05-26

Start date

2009-11-30

Completion date

2020-10-31

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

VIBATIV, telavancin, Pregnancy, Registry

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.

Interventions

DRUGVIBATIV

Observational

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	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

Secondary

Measure	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.
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026