Hospital Acquired Bacterial PneumoniaTOURNCT02288234
Telavancin Observational Use Registry (TOUR)
An observational study of Hospital Acquired Bacterial Pneumonia and Complicated Skin and Skin Structure Infections, run by Cumberland Pharmaceuticals at 1 site in United States.
Trial summary
The telavancin observational use registry (TOUR) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who are receiving clinician directed telavancin therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hospital Acquired Bacterial Pneumonia, Complicated Skin and Skin Structure Infections, Ventilator Associated Bacterial Pneumonia
- What is being tested?
- Vibativ
- How many people
- 1,063 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Oct 2017
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will aim to enroll approximately 1,000 patients from 50-60 hospital sites or outpatient infusion centers.
Who may be able to join
- -received at least 1 dose of telavancin since January 1, 2015
Who cannot join
- Participation in an interventional research study or clinical trial involving telavancin after January 01, 2015
Trial locations and contacts
1 site in 1 country.
United States1 site
Newland Medical Associates
Southfield, Michigan, 48075
About this study
The telavancin observational use registry (TOUR) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who are receiving clinician directed telavancin therapy.
Read the detailed description
This is a retrospective medical chart review, multicenter, observational study to examine telavancin efficacy and safety in a real-word setting and to characterize the pattern of use of telavancin in hospital-based inpatients and in outpatient infusion centers. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol.
- Conditions
- Hospital Acquired Bacterial Pneumonia, Complicated Skin and Skin Structure Infections, Ventilator Associated Bacterial Pneumonia, Gram Positive Infection
- Being tested
- Vibativ
- Keywords
- Registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibativDrug
Also called telavancin
This is an observational study for patients who were already prescribed Vibativ.
| Study group | Role | What they receive |
|---|---|---|
| Vibativ | This is an observational study for patients who were already prescribed Vibativ. Receives: Drug: Vibativ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical response
defined as the number of days between initiation of telavancin therapy and date of cure, where cure is defined as the resolution of the signs and symptoms of infection and/or no need for additional antibiotic therapy, or clearance of the infection with a negative culture result [Mohr 2009]
Measured: 6 months
Secondary outcomes (1)
Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hospital Acquired Bacterial PneumoniaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,063 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288234
- Sponsor's protocol ID
- 0120
- Acronym
- TOUR
- Status last verified
- Jan 2019
- First submitted
- 5 Nov 2014
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Sims CR, Bressler AM, Graham DR, Lacy MK, Lombardi DA, Castaneda-Ruiz B. Real-World Clinical Use and Outcomes of Telavancin for the Treatment of Bone and Joint Infections: Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2021 Dec;8(4):509-518. doi: 10.1007/s40801-021-00255-6. Epub 2021 May 26.
PubMed 34041706Reilly J, Jacobs MA, Friedman B, Cleveland KO, Lombardi DA, Castaneda-Ruiz B. Clinical Experience with Telavancin for the Treatment of Patients with Bacteremia and Endocarditis: Real-World Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2020 Sep;7(3):179-189. doi: 10.1007/s40801-020-00191-x.
PubMed 32372280
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telavancin Observational Use Registry (TOUR)
- ClinicalTrials.gov ID
- NCT02288234
- Acronym / sponsor ID
- TOUR / 0120
- Conditions
- Hospital Acquired Bacterial Pneumonia, Complicated Skin and Skin Structure Infections, Ventilator Associated Bacterial Pneumonia, Gram Positive Infection
- Keywords
- Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,063 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 11 Nov 2014 (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 telavancin observational use registry (TOUR) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who are receiving clinician directed telavancin therapy.
Detailed description
This is a retrospective medical chart review, multicenter, observational study to examine telavancin efficacy and safety in a real-word setting and to characterize the pattern of use of telavancin in hospital-based inpatients and in outpatient infusion centers. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibativ | – | Drug: VibativThis is an observational study for patients who were already prescribed Vibativ. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will aim to enroll approximately 1,000 patients from 50-60 hospital sites or outpatient infusion centers.
Key inclusion criteria (1 listed)
- -received at least 1 dose of telavancin since January 1, 2015
Key exclusion criteria (1 listed)
- Participation in an interventional research study or clinical trial involving telavancin after January 01, 2015
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: telavancinThis is an observational study for patients who were already prescribed Vibativ. | Drug | Vibativ |
Primary outcome
Time to clinical response
Time frame: 6 months
defined as the number of days between initiation of telavancin therapy and date of cure, where cure is defined as the resolution of the signs and symptoms of infection and/or no need for additional antibiotic therapy, or clearance of the infection with a negative culture result [Mohr 2009]
1 secondary outcome
Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 34041706Sims CR, Bressler AM, Graham DR, Lacy MK, Lombardi DA, Castaneda-Ruiz B. Real-World Clinical Use and Outcomes of Telavancin for the Treatment of Bone and Joint Infections: Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2021 Dec;8(4):509-518. doi: 10.1007/s40801-021-00255-6. Epub 2021 May 26.
- Derived from this study: PubMed 32372280Reilly J, Jacobs MA, Friedman B, Cleveland KO, Lombardi DA, Castaneda-Ruiz B. Clinical Experience with Telavancin for the Treatment of Patients with Bacteremia and Endocarditis: Real-World Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2020 Sep;7(3):179-189. doi: 10.1007/s40801-020-00191-x.
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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.
Medical Monitor study director
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 Hospital Acquired Bacterial Pneumonia and Complicated Skin and Skin Structure Infections, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jan 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to clinical response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02288234, which also lists 2 linked publications.
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 15 Jan 2019.