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

This study is currently recruiting participants.
Verified July 2017 by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02208063
First Posted: August 4, 2014
Last Update Posted: July 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
July 31, 2014
August 4, 2014
July 21, 2017
December 2014
March 2018   (Final data collection date for primary outcome measure)
Clinical response (success or failure) [ Time Frame: Up to 8 weeks ]
Clinical response (success or failure) for subjects with uncomplicated bacteremia receiving 2 to 4 weeks of treatment at test of cure (TOC) (38 [+/-2] days after randomization), for subjects with complicated bacteremia receiving 4 to 6 weeks of treatment at test of cure (TOC) (52 [+/-2] days after randomization), and for subjects with endocarditis receiving 6 weeks of treatment at test of cure (TOC) (52 [+/-2] days after randomization)
Clinical response (success or failure) [ Time Frame: Up to 10 weeks ]
Clinical response (success or failure) at test of cure (TOC) (28 [+/-2] days after end of treatment (EOT)) in the mITT analysis set
Complete list of historical versions of study NCT02208063 on ClinicalTrials.gov Archive Site
  • Development of new metastatic foci of infection [ Time Frame: After Day 8 ]
  • Clearance of bacteremia [ Time Frame: Up to 8 weeks ]
    For subjects with a positive S. aureus blood culture on Day 1, time to all blood cultures negative for S. aureus for two days in succession
  • Development of new metastatic foci of infection [ Time Frame: After Day 8 ]
  • Clearance of bacteremia [ Time Frame: Up to 10 weeks ]
    For subjects with a positive S. aureus blood culture on Day 1, time to all blood cultures negative for S. aureus for two days in succession
Not Provided
Not Provided
 
A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
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
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 (RIE).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bacteremia
  • Drug: Telavancin
  • Drug: Vancomycin
  • Drug: Daptomycin
    Other Name: Cubicin
  • Drug: Synthetic penicillin
    Other Names:
    • Nafcillin
    • Oxacillin
    • Cloxacillin
  • Drug: Cefazolin
  • Experimental: Telavancin
    7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes
    Intervention: Drug: Telavancin
  • Active Comparator: Standard of care
    Vancomycin, Daptomycin, synthetic penicillin or Cefazolin
    Interventions:
    • Drug: Vancomycin
    • Drug: Daptomycin
    • Drug: Synthetic penicillin
    • Drug: Cefazolin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
248
May 2018
March 2018   (Final data collection date for primary outcome measure)

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
    • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Roger Kohler 650-808-6000 RKohler@theravance.com
Contact: Mia Elliott 650-808-6000 MElliott@theravance.com
United States
 
 
NCT02208063
0112
Yes
Not Provided
Plan to Share IPD: Undecided
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
Theravance Biopharma R & D, Inc.
Not Provided
Study Director: Bibiana Castaneda, MD Theravance Biopharma R & D, Inc.
Theravance Biopharma Antibiotics, Inc.
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP