Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis

• Status: Terminated
• Trial end date: 2017-08-04
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the completion of therapy in patients with complicated bacteremia or infective endocarditis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Dalbavancin; Teicoplanin

Criteria

Inclusion Criteria:

• A diagnosis of complicated bacteremia or infective endocarditis

• Gram-positive bacteremia at screening with methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA) or Streptococci

• Treatment with standard of care antibiotics for 72 hours (h) - 10 days

• Defervescence for at least 24h and clearance of bacteremia from screening pathogen.

Exclusion Criteria:

• Embolic events

• History of prosthetic valve surgery, cardiac device or prosthetic joint

• Left-sided endocarditis due to Staphylococcus aureus (S. aureus)

• Large mobile vegetations (>10 mm) on mitral valves

• Perivalvular abscess

• Uncomplicated bacteremia due to S. aureus

• Gram-negative bacteria or fungi in blood cultures

• Heart failure associated with infective endocarditis [Left Ventricular Ejection Fraction (LVEF) <40%]

• Intravascular material or removable infection source not intended to be removed within 4 days postrandomization

• Planned valve replacement surgery within 3 days of randomization

• Refractory shock, significant hepatic insufficiency or severe leukopenia [Absolute Neutrophil Count (ANC) < 500 cells/mm^3]

• Known osteomyelitis

• Hypersensitivity to dalbavancin or other drugs in glycopeptide class

• Infection with enterococci, coagulase-negative staphylococci, or with organism not susceptible to dalbavancin or vancomycin

• Immunosuppression/immune deficiency

• Concomitant systemic antibacterial therapy for gram-positive infection other than that allowed in protocol

• Pregnant or nursing females.