A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
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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
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Condition or disease | Intervention/treatment | Phase |
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Bacteremia | Drug: Telavancin Drug: Vancomycin Drug: Daptomycin Drug: Synthetic penicillin Drug: Cefazolin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 121 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 |
Actual Primary Completion Date : | April 12, 2018 |
Actual Study Completion Date : | April 12, 2018 |

Arm | Intervention/treatment |
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Experimental: Telavancin
7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes
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Drug: Telavancin |
Active Comparator: Standard of care
Vancomycin, Daptomycin, synthetic penicillin or Cefazolin
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Drug: Vancomycin Drug: Daptomycin Other Name: Cubicin Drug: Synthetic penicillin Other Names:
Drug: Cefazolin |
- 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).
- 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
- 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:
- 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 [ 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years of age or older with at least one blood culture positive for S. aureus within 48 hours before randomization
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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

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
United States, Ohio | |
Remington-Davis Clinical Research | |
Columbus, Ohio, United States, 43215 |
Study Director: | Medical Monitor | Cumberland Pharmaceuticals, Inc. |
Documents provided by Cumberland Pharmaceuticals:
Responsible Party: | Cumberland Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02208063 |
Other Study ID Numbers: |
0112 |
First Posted: | August 4, 2014 Key Record Dates |
Results First Posted: | February 17, 2020 |
Last Update Posted: | February 17, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Bacteremia Staphylococcus aureus |
Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Vancomycin |
Cefazolin Daptomycin Penicillins Cloxacillin Oxacillin Nafcillin Telavancin Anti-Bacterial Agents Anti-Infective Agents |