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A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

Primary Purpose

Bacteremia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Telavancin
Vancomycin
Daptomycin
Synthetic penicillin
Cefazolin
Sponsored by
Cumberland Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacteremia focused on measuring Bacteremia, Staphylococcus aureus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older with at least one blood culture positive for S. aureus within 48 hours before randomization

  • At least one of the following signs or symptoms of bacteremia:

    • Temperature ≥ 38.0°C
    • White blood cell (WBC) count > 10,000 or < 4,000 cells/µL or > 10% immature neutrophils (bands)
    • Tachycardia (heart rate > 90 bpm)
    • Tachypnea (respiratory rate > 20 breaths/min)
    • Hypotension (systolic blood pressure < 90 mmHg)
    • Signs or symptoms of localized catheter-related infection
  • At enrollment, subjects must have either 1) known right-sided infective endocarditis by Modified Duke's criteria 2) known complicated bacteremia, demonstrated as signs or symptoms of metastatic foci of S. aureus infection or 3) at least one risk factor for complicated bacteremia.

Exclusion Criteria:

  • Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 60 hours within 7 days before randomization. EXCEPTION: Documented resistance to the prior systemic antibacterial therapy
  • Presence of an infection source that will not be managed or controlled within the first 3 days of study drug treatment
  • Presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter defibrillator [ICD]), permanent pacemaker, or cardiac valve support ring)
  • Known or suspected left-sided infective endocarditis (LIE), by Modified Duke Criteria. NOTE: Right-sided infective endocarditis (RIE) is permitted
  • Known or suspected osteomyelitis or meningitis. NOTE: Evidence of metastatic complications related to the primary infection such as right-sided endocarditis, septic arthritis, septic pulmonary emboli are permitted. S. aureus pneumonia is permitted
  • Confirmed evidence (identification or gram stain) of a mixed polymicrobial infection with a Gram-negative pathogen that requires non-study antibiotic treatment with agent(s) that have activity against Gram-negative pathogens

Sites / Locations

  • Remington-Davis Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telavancin

Standard of care

Arm Description

7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes

Vancomycin, Daptomycin, synthetic penicillin or Cefazolin

Outcomes

Primary Outcome Measures

Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)
The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC). Alive at TOC Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC No evidence of microbiological persistence of relapse No new foci of metastatic S. aureus infection after Day 8

Secondary Outcome Measures

Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population
The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria: Subject alive at TOC Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis) No evidence of microbiological persistence or relapse No new foci of metastatic S. aureus infection after Day 8
Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population
This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response
Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations
After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection

Full Information

First Posted
July 31, 2014
Last Updated
February 13, 2020
Sponsor
Cumberland Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02208063
Brief Title
A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
Official Title
A Phase 3 Multicenter, Randomized, Open-label, Clinical Trial of Telavancin Versus Standard Intravenous Therapy in the Treatment of Subjects With Staphylococcus Aureus Bacteremia Including Infective Endocarditis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Halted due to lack of statistical power. No safety concerns identified.
Study Start Date
December 2014 (Actual)
Primary Completion Date
April 12, 2018 (Actual)
Study Completion Date
April 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cumberland Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S. aureus) bacteremia and SA right-sided infective endocarditis (SA-RIE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia
Keywords
Bacteremia, Staphylococcus aureus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telavancin
Arm Type
Experimental
Arm Description
7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Vancomycin, Daptomycin, synthetic penicillin or Cefazolin
Intervention Type
Drug
Intervention Name(s)
Telavancin
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Other Intervention Name(s)
Cubicin
Intervention Type
Drug
Intervention Name(s)
Synthetic penicillin
Other Intervention Name(s)
Nafcillin, Oxacillin, Cloxacillin
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Primary Outcome Measure Information:
Title
Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)
Description
The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC). Alive at TOC Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC No evidence of microbiological persistence of relapse No new foci of metastatic S. aureus infection after Day 8
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population
Description
The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria: Subject alive at TOC Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis) No evidence of microbiological persistence or relapse No new foci of metastatic S. aureus infection after Day 8
Time Frame
Up to 8 weeks
Title
Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population
Description
This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response
Time Frame
Up to 8 weeks
Title
Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations
Description
After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older with at least one blood culture positive for S. aureus within 48 hours before randomization At least one of the following signs or symptoms of bacteremia: Temperature ≥ 38.0°C White blood cell (WBC) count > 10,000 or < 4,000 cells/µL or > 10% immature neutrophils (bands) Tachycardia (heart rate > 90 bpm) Tachypnea (respiratory rate > 20 breaths/min) Hypotension (systolic blood pressure < 90 mmHg) Signs or symptoms of localized catheter-related infection At enrollment, subjects must have either 1) known right-sided infective endocarditis by Modified Duke's criteria 2) known complicated bacteremia, demonstrated as signs or symptoms of metastatic foci of S. aureus infection or 3) at least one risk factor for complicated bacteremia. Exclusion Criteria: Treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 60 hours within 7 days before randomization. EXCEPTION: Documented resistance to the prior systemic antibacterial therapy Presence of an infection source that will not be managed or controlled within the first 3 days of study drug treatment Presence of prosthetic cardiac valve or cardiac device (eg, implantable cardioverter defibrillator [ICD]), permanent pacemaker, or cardiac valve support ring) Known or suspected left-sided infective endocarditis (LIE), by Modified Duke Criteria. NOTE: Right-sided infective endocarditis (RIE) is permitted Known or suspected osteomyelitis or meningitis. NOTE: Evidence of metastatic complications related to the primary infection such as right-sided endocarditis, septic arthritis, septic pulmonary emboli are permitted. S. aureus pneumonia is permitted Confirmed evidence (identification or gram stain) of a mixed polymicrobial infection with a Gram-negative pathogen that requires non-study antibiotic treatment with agent(s) that have activity against Gram-negative pathogens
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Cumberland Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Remington-Davis Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

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