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

• ClinicalTrials.gov Identifier: NCT02208063
• Recruitment Status: Terminated
• First Posted: August 4, 2014
• Last Update Posted: January 15, 2019
• Sponsor: Cumberland Pharmaceuticals
• Information provided by (Responsible Party): Cumberland Pharmaceuticals

Study Description

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 (RIE).

Condition or disease	Intervention/treatment	Phase
Bacteremia	Drug: Telavancin; Drug: Vancomycin; Drug: Daptomycin; Drug: Synthetic penicillin; Drug: Cefazolin	Phase 3

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Clinical response (success or failure) [ Time Frame: Up to 8 weeks ]
   Clinical response (success or failure) for subjects with uncomplicated bacteremia receiving 2 to 4 weeks of treatment at test of cure (TOC) (38 [+/-2] days after randomization), for subjects with complicated bacteremia receiving 4 to 6 weeks of treatment at test of cure (TOC) (52 [+/-2] days after randomization), and for subjects with endocarditis receiving 6 weeks of treatment at test of cure (TOC) (52 [+/-2] days after randomization)

Secondary Outcome Measures :

1. Development of new metastatic foci of infection [ Time Frame: After Day 8 ]
2. Clearance of bacteremia [ Time Frame: Up to 8 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
  • 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

Contacts and Locations

Locations

United States, Ohio

Remington-Davis Clinical Research

Columbus, Ohio, United States, 43215

Sponsors and Collaborators

Cumberland Pharmaceuticals

Investigators

• Study Director: Medical Monitor; Cumberland Pharmaceuticals, Inc.

More Information

• Responsible Party: Cumberland Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02208063 History of Changes
• Other Study ID Numbers: 0112
• First Posted: August 4, 2014
• Last Update Posted: January 15, 2019
• Last Verified: January 2019

Keywords provided by Cumberland Pharmaceuticals:

Bacteremia; Staphylococcus aureus

Additional relevant MeSH terms:

Bacteremia; Bacterial Infections; Sepsis; Infection; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Vancomycin; Cefazolin; Penicillins; Daptomycin; Telavancin; Anti-Bacterial Agents; Anti-Infective Agents