Clinical trial NCT03148756: 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
Official title: Phase 2, Open-Label, Randomized, Multicenter Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Documented Infective Endocarditis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Endocarditis
Bacteremia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-05-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population
timeFrame: Day 84
Secondary outcomes:
measure: Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population
timeFrame: Day 42
measure: Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population
timeFrame: Day 42
measure: Number of Participants With Day 84 Mortality in the Safety Population
timeFrame: Day 84
measure: Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population
timeFrame: Day 84
measure: Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population
timeFrame: Day 42
measure: Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population
timeFrame: Day 84
measure: Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population
timeFrame: Day 42
measure: Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population
timeFrame: Day 84
measure: Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population
timeFrame: Day 42
measure: Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population
timeFrame: Day 84
measure: Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population
timeFrame: Day 42
measure: Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population
timeFrame: Day 84
Other outcomes:
Locations:
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center
state: Florida
Study officials:
affiliation: Allergan
name: Urania Rappo, MD
role: STUDY_DIRECTOR
References: