PregnancyNCT01130324
VIBATIV Pregnancy Registry
An observational study of Pregnancy, run by Cumberland Pharmaceuticals at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- VIBATIV
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Oct 2020
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women exposed to VIBATIV during pregnancy and where outcome of pregnancy is unknown at time of enrollment.
Who may be able to join
- Female patients who were exposed to VIBATIV at any time during pregnancy
- Outcome of pregnancy is unknown at the time of enrollment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cumberland Pharmaceuticals Inc.
Nashville, Tennessee, 37203
About this study
Official title: 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.
- Conditions
- Pregnancy
- Being tested
- VIBATIV
- Keywords
- VIBATIV, telavancin, Pregnancy, Registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIBATIVDrug
Also called telavancin, TD-6424
Observational
| Study group | Role | What they receive |
|---|---|---|
| VIBATIV treated pregnant women | Women treated with telavancin (any dose or duration) during pregnancy. Receives: Drug: VIBATIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy
Measured: Once per trimester, 6-7 months gestation, and within 4 weeks after the estimated due date
Secondary outcomes (3)
Effect of fetal exposure to VIBATIV on pregnancy outcomes
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startNov 2009
- Primary completionOct 2020
- Study completionOct 2020
Why it stopped: Released by he FDA from this Post-Marketing Commitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Haberle, PhD, Principal investigator, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130324
- Sponsor's protocol ID
- 0113
- Status last verified
- Oct 2020
- First submitted
- 24 May 2010
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIBATIV (Telavancin Hydrochloride) Pregnancy Exposure Registry
- ClinicalTrials.gov ID
- NCT01130324
- Acronym / sponsor ID
- 0113
- Conditions
- Pregnancy
- Keywords
- VIBATIV, telavancin, Pregnancy, Registry
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Released by he FDA from this Post-Marketing Commitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIBATIV treated pregnant women | – | Drug: VIBATIVWomen treated with telavancin (any dose or duration) during pregnancy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women exposed to VIBATIV during pregnancy and where outcome of pregnancy is unknown at time of enrollment.
Key inclusion criteria (2 listed)
- Female patients who were exposed to VIBATIV at any time during pregnancy
- Outcome of pregnancy is unknown at the time of enrollment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIBATIVAlso: telavancin, TD-6424Observational | Drug | VIBATIV treated pregnant women |
Primary outcome
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
3 secondary outcomes
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Haberle, PhD principal investigator
Cumberland Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Cumberland Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.