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Trial record 4 of 8 for:    NAFCILLIN AND cloxacillin

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

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: NCT02208063
Recruitment Status : Terminated (Halted due to lack of statistical power. No safety concerns identified. Enrolled subjects were allowed to complete scheduled study activities.)
First Posted : August 4, 2014
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 31, 2014
First Posted Date  ICMJE August 4, 2014
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date April 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2014)
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
Change History Complete list of historical versions of study NCT02208063 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2014)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bacteremia
Intervention  ICMJE
  • Drug: Telavancin
  • Drug: Vancomycin
  • Drug: Daptomycin
    Other Name: Cubicin
  • Drug: Synthetic penicillin
    Other Names:
    • Nafcillin
    • Oxacillin
    • Cloxacillin
  • Drug: Cefazolin
Study Arms  ICMJE
  • 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
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  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 10, 2018)
121
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2014)
248
Actual Study Completion Date  ICMJE April 12, 2018
Actual Primary Completion Date April 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02208063
Other Study ID Numbers  ICMJE 0112
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cumberland Pharmaceuticals
Study Sponsor  ICMJE Cumberland Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Cumberland Pharmaceuticals, Inc.
PRS Account Cumberland Pharmaceuticals
Verification Date January 2019

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