VIBATIV Pregnancy Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Theravance Biopharma Antibiotics, Inc.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT01130324
First received: May 24, 2010
Last updated: June 24, 2016
Last verified: June 2016

May 24, 2010
June 24, 2016
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: Yes ]
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 ]
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: Yes ]
  • 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: Yes ]
  • 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: Yes ]
  • 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 ]
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
Drug: VIBATIV
Observational
Other Names:
  • telavancin
  • TD-6424
VIBATIV treated pregnant women
Women treated with telavancin (any dose or duration) during pregnancy.
Intervention: Drug: VIBATIV
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
Child, Adult, Senior
No
Contact: Mia Elliott (650) 808-6444 MElliott@theravance.com
Contact: Theravance Biopharma Antibiotics, Inc. Medical Information 1-855-633-8479
United States
 
NCT01130324
0113
Yes
Yes
Not Provided
Theravance Biopharma Antibiotics, Inc.
Theravance Biopharma Antibiotics, Inc.
Not Provided
Study Director: Bibiana Castaneda, MD Theravance Biopharma Antibiotics, Inc.
Theravance Biopharma Antibiotics, Inc.
June 2016

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