NCT01130324

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

10.9 years

First QC Date

May 24, 2010

Last Update Submit

October 14, 2020

Conditions

Pregnancy

Keywords

VIBATIVtelavancinPregnancyRegistry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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.

Study Arms (1)

VIBATIV treated pregnant women

Women treated with telavancin (any dose or duration) during pregnancy.

Drug: VIBATIV

Interventions

VIBATIVDRUG

Observational

Also known as: telavancin, TD-6424
VIBATIV treated pregnant women

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women exposed to VIBATIV during pregnancy and where outcome of pregnancy is unknown at time of enrollment.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cumberland Pharmaceuticals Inc.

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Interventions

telavancin

Study Officials

  • Adam Haberle, PhD

    Cumberland Pharmaceuticals, Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 26, 2010

Study Start

November 1, 2009

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

US(1)