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VIBATIV Pregnancy Registry

This study is currently recruiting participants.
Verified July 2017 by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01130324
First Posted: May 26, 2010
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
May 24, 2010
May 26, 2010
July 21, 2017
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 ]
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. ]
  • 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. ]
  • 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. ]
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
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
 
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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact: Mia Elliott (650) 808-6444 MElliott@theravance.com
Contact: Theravance Biopharma R&D, Inc. Medical Information 1-855-633-8479
United States
 
 
NCT01130324
0113
Yes
Not Provided
Plan to Share IPD: Undecided
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
Theravance Biopharma R & D, Inc.
Not Provided
Study Director: Bibiana Castaneda, MD Theravance Biopharma R & D, Inc.
Theravance Biopharma Antibiotics, Inc.
July 2017