VIBATIV Pregnancy Registry

This study is currently recruiting participants.
Verified March 2014 by Theravance, Inc.
Sponsor:
Information provided by (Responsible Party):
Theravance, Inc.
ClinicalTrials.gov Identifier:
NCT01130324
First received: May 24, 2010
Last updated: March 20, 2014
Last verified: March 2014

May 24, 2010
March 20, 2014
November 2009
June 2019   (final data collection date for primary outcome measure)
Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy [ Time Frame: Once per trimester, 6-7 months gestation, and within 4 weeks after the estimated due date ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01130324 on ClinicalTrials.gov Archive Site
  • Effect of fetal exposure to VIBATIV on pregnancy outcomes [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Fetal/neonatal outcomes [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Infant development and milestones through 12 months of age [ Time Frame: 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
VIBATIV Pregnancy Registry
VIBATIV (Telavancin Hydrochloride) Pregnancy Exposure Registry

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.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
9 Months
Not Provided
Non-Probability Sample

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

  • Pregnancy
  • Congenital Defects
  • Infant, Low Birth Weight
Drug: telavancin
Observational
Other Names:
  • VIBATIV
  • TD-6424
VIBATIV exposed pregnant women
Pregnant women exposed to VIBATIV (telavancin hydrochloride) during pregnancy where outcome of pregnancy is unknown at the time of enrollment
Intervention: Drug: telavancin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
June 2019
June 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female patients who were exposed to VIBATIV at any time during pregnancy
  • Outcome of pregnancy is unknown at the time of enrollment
Female
Not Provided
No
Contact: Theravance, Inc. Medical Information 1-855-633-8479
United States
 
NCT01130324
0113
Yes
Theravance, Inc.
Theravance, Inc.
Not Provided
Principal Investigator: Principal Investigator Theravance, Inc.
Theravance, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP