Telavancin Observational Use Registry (TOUR) (TOUR)

• ClinicalTrials.gov Identifier: NCT02288234
• Recruitment Status: Completed
• First Posted: November 11, 2014
• Last Update Posted: January 15, 2019
• Sponsor: Cumberland Pharmaceuticals
• Information provided by (Responsible Party): Cumberland Pharmaceuticals

Tracking Information

• First Submitted Date: November 5, 2014
• First Posted Date: November 11, 2014
• Last Update Posted Date: January 15, 2019
• Actual Study Start Date: November 2014
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 6, 2014)

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]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 9, 2018): Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs) [ Time Frame: 30 days ]

Original Secondary Outcome Measures (submitted: November 6, 2014)

Collecting AEs of special interest [ Time Frame: 6 months ]

• The AEs: Nephrotoxicity (as measured by serum creatinine) >=0.5 mg/dL or >=50% increase from Baseline Infusion reactions (e.g., "Red-man syndrome", flushing of the upper body, urticaria, pruritus, or rash)

• QTc >500 msec absolute value
• Nausea and Vomiting moderate or severe in intensity, with no other likely cause (e.g. New med)
• Hypersensitivity reaction

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Telavancin Observational Use Registry (TOUR)
• Official Title: Telavancin Observational Use Registry (TOUR)
• Brief 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.
• 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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: The study will aim to enroll approximately 1,000 patients from 50-60 hospital sites or outpatient infusion centers.

Condition

• Hospital Acquired Bacterial Pneumonia
• Complicated Skin and Skin Structure Infections
• Ventilator Associated Bacterial Pneumonia
• Gram Positive Infection

Intervention

Drug: Vibativ

This is an observational study for patients who were already prescribed Vibativ.

Other Name: telavancin

Study Groups/Cohorts

Vibativ

This is an observational study for patients who were already prescribed Vibativ.

Intervention: Drug: Vibativ

• Publications *: Reilly 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 10, 2018): 1063
• Original Estimated Enrollment (submitted: November 6, 2014): 1000
• Actual Study Completion Date: October 2017
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

-received at least 1 dose of telavancin since January 1, 2015

Exclusion Criteria:

• Participation in an interventional research study or clinical trial involving telavancin after January 01, 2015

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02288234
• Other Study ID Numbers: 0120
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Cumberland Pharmaceuticals
• Study Sponsor: Cumberland Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Cumberland Pharmaceuticals, Inc.

• PRS Account: Cumberland Pharmaceuticals
• Verification Date: January 2019