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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03148756
• Date of registration: 09/05/2017
• Prospective Registration: Yes
• Primary sponsor: Allergan
• Public title: 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
• Scientific 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
• Date of first enrolment: May 12, 2017
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03148756
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Korea, Republic of, Singapore, Taiwan, United Kingdom, United States

Contacts

• Name: Urania Rappo, MD
• Affiliation: Allergan

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Endocarditis

Bacteremia

Intervention(s)

Drug: Standard of Care

Drug: Dalbavancin

Primary Outcome(s)

Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population [Time Frame: Day 84]

Secondary Outcome(s)

Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population [Time Frame: Day 84]

Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population [Time Frame: Day 84]

Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population [Time Frame: Day 42]

Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population [Time Frame: Day 84]

Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population [Time Frame: Day 84]

Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population [Time Frame: Day 42]

Number of Participants With Day 84 Mortality in the Safety Population [Time Frame: Day 84]

Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population [Time Frame: Day 84]

Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population [Time Frame: Day 42]

Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population [Time Frame: Day 42]

Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population [Time Frame: Day 42]

Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population [Time Frame: Day 42]

Secondary ID(s)

DAL-MD-09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03148756