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

Cumberland Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Bacteremia

Treatments: Drug: Cefazolin; Drug: Vancomycin; Drug: Daptomycin; Drug: Telavancin; Drug: Synthetic penicillin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02208063

0112

Details and patient eligibility

About

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).

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

Telavancin

Experimental group

Description:

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

Treatment:

Drug: Telavancin

Standard of care

Active Comparator group

Description:

Vancomycin, Daptomycin, synthetic penicillin or Cefazolin

Treatment:

Drug: Cefazolin

Drug: Synthetic penicillin

Drug: Vancomycin

Drug: Daptomycin