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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.)
First Posted : August 4, 2014
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Cumberland Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 31, 2014
First Posted Date  ICMJE August 4, 2014
Results First Submitted Date  ICMJE October 16, 2019
Results First Posted Date  ICMJE February 17, 2020
Last Update Posted Date February 17, 2020
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: February 13, 2020)
Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC) [ Time Frame: Up to 8 weeks ]
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).
  1. Alive at TOC
  2. Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC
  3. No evidence of microbiological persistence of relapse
  4. No new foci of metastatic S. aureus infection after Day 8
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
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2020)
  • Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population [ Time Frame: Up to 8 weeks ]
    The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria:
    1. Subject alive at TOC
    2. Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis)
    3. No evidence of microbiological persistence or relapse
    4. 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 [ Time Frame: Up to 8 weeks ]
    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 [ Time Frame: Day 8 ]
    After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection
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 (SA-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
    • 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
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
Plan to Share IPD: No
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 February 2020

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