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Telavancin Observational Use Registry (TOUR) (TOUR)

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: NCT02288234
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : January 15, 2019
Sponsor:
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
Change History Complete list of historical versions of study NCT02288234 on ClinicalTrials.gov Archive Site
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 * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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