Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT03148756
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03148756
Study Brief:
Protocol Section:
NCT03148756