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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-12

Study Completion Date

2017-08-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Endocarditis Bacteremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dalbavancin

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

Group Type EXPERIMENTAL

Dalbavancin

Intervention Type DRUG

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

Standard of Care

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

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type DRUG

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

Interventions

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Dalbavancin

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

Intervention Type DRUG

Standard of Care

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No