Clinical trial NCT02208063: A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bacteremia
Keywords: Bacteremia
Staphylococcus aureus
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-08-04
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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
  * 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

Primary outcomes:
measure: Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population
timeFrame: Up to 8 weeks
measure: Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population
timeFrame: Up to 8 weeks
measure: 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
timeFrame: Day 8
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Remington-Davis Clinical Research
state: Ohio
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: