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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01130324
Other study ID # 0113
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 2009
Est. completion date October 2020

Study information

Verified date October 2020
Source Cumberland Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Female patients who were exposed to VIBATIV at any time during pregnancy - Outcome of pregnancy is unknown at the time of enrollment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
VIBATIV
Observational

Locations

Country Name City State
United States Cumberland Pharmaceuticals Inc. Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy Once per trimester, 6-7 months gestation, and within 4 weeks after the estimated due date
Secondary Effect of fetal exposure to VIBATIV on pregnancy outcomes 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.
Secondary Fetal/neonatal outcomes 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.
Secondary Infant development and milestones through 12 months of age 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.
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