Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

VIBATIV Pregnancy Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: January 2, 2015
Last verified: March 2014

May 24, 2010
January 2, 2015
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: telavancin
Observational
Other Names:
  • VIBATIV
  • TD-6424
VIBATIV treated pregnant women
Women treated with telavancin (any dose or duration) during pregnancy.
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 Biopharma Antibiotics, Inc. Medical Information 1-855-633-8479
United States
 
NCT01130324
0113
Yes
Theravance Biopharma Antibiotics, Inc.
Theravance Biopharma Antibiotics, Inc.
Not Provided
Study Director: Principal Investigator Theravance Biopharma Antibiotics, Inc.
Theravance Biopharma Antibiotics, Inc.
March 2014

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