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

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Bacteremia; Endocarditis

Treatments: Drug: Dalbavancin; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT03148756

DAL-MD-09

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Dalbavancin

Experimental group

Description:

Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.

Treatment:

Drug: Dalbavancin

Standard of Care

Active Comparator group

Description:

Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.

Treatment:

Drug: Standard of Care