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

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ClinicalTrials.gov Identifier: NCT02208063
Recruitment Status : Active, not recruiting
First Posted : August 4, 2014
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc.

Study Description
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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 (RIE).

Condition or disease Intervention/treatment Phase
Bacteremia Drug: Telavancin Drug: Vancomycin Drug: Daptomycin Drug: Synthetic penicillin Drug: Cefazolin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2014
Estimated Primary Completion Date : April 15, 2018
Estimated Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Telavancin
7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes
 Drug: Telavancin
Active Comparator: Standard of care
Vancomycin, Daptomycin, synthetic penicillin or Cefazolin
 Drug: Vancomycin
Drug: Daptomycin
Other Name: Cubicin

Drug: Synthetic penicillin
Other Names:
  • Nafcillin
  • Oxacillin
  • Cloxacillin

Drug: Cefazolin


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Development of new metastatic foci of infection [ Time Frame: After Day 8 ]
  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
    • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208063


Locations
United States, Ohio
Remington-Davis Clinical Research
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
Theravance Biopharma Antibiotics, Inc.
Investigators
Study Director: Bibiana Castaneda, MD Theravance Biopharma R & D, Inc.
More Information
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Responsible Party: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier: NCT02208063     History of Changes
Other Study ID Numbers: 0112
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Bacteremia
Staphylococcus aureus

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
 Vancomycin
Cefazolin
Daptomycin
Penicillins
Telavancin
Anti-Bacterial Agents
Anti-Infective Agents