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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-04-12

Brief Summary

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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).

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Detailed Description

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Conditions

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Bacteremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telavancin

7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes

Group Type EXPERIMENTAL

Telavancin

Intervention Type DRUG

Standard of care

Vancomycin, Daptomycin, synthetic penicillin or Cefazolin

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Daptomycin

Intervention Type DRUG

Synthetic penicillin

Intervention Type DRUG

Cefazolin

Intervention Type DRUG

Interventions

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Telavancin

Intervention Type DRUG

Vancomycin

Intervention Type DRUG

Daptomycin

Intervention Type DRUG

Synthetic penicillin

Intervention Type DRUG

Cefazolin

Intervention Type DRUG

Other Intervention Names

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Cubicin Nafcillin Oxacillin Cloxacillin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No