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VIBATIV Pregnancy Registry

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01130324
Recruitment Status : Withdrawn (Released by he FDA from this Post-Marketing Commitment)
First Posted : May 26, 2010
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment
Pregnancy Drug: VIBATIV

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: VIBATIV (Telavancin Hydrochloride) Pregnancy Exposure Registry
Study Start Date : November 2009
Actual Primary Completion Date : October 2020
Actual Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort Intervention/treatment
VIBATIV treated pregnant women
Women treated with telavancin (any dose or duration) during pregnancy.
 Drug: VIBATIV
Observational
Other Names:
  • telavancin
  • TD-6424


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women exposed to VIBATIV during pregnancy and where outcome of pregnancy is unknown at time of enrollment.
Criteria

Inclusion Criteria:

  • Female patients who were exposed to VIBATIV at any time during pregnancy
  • Outcome of pregnancy is unknown at the time of enrollment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130324


Locations
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United States, Tennessee
Cumberland Pharmaceuticals Inc.
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Cumberland Pharmaceuticals
Investigators
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Principal Investigator: Adam Haberle, PhD Cumberland Pharmaceuticals, Inc.
More Information
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Additional Information:

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Responsible Party: Cumberland Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01130324    
Other Study ID Numbers: 0113
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Keywords provided by Cumberland Pharmaceuticals:
VIBATIV
telavancin
Pregnancy
Registry
Additional relevant MeSH terms:
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Telavancin
Anti-Bacterial Agents
Anti-Infective Agents