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

NCT03148756 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: DAL-MD-09
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Endocarditis; Bacteremia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population

  Clinical response was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. Failure was defined as: ongoing signs and symptoms considered by the investigator to be related to complicated bacteremia or IE requiring additional antibacterial therapy or unplanned valve replacement, recurrent bacteremia, death during the study period up to Day 84 or discontinuation of the study medication due to an adverse event.

  Day 84

Secondary Outcomes (12)

• Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population

  Day 42

• Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population

  Day 42

• Number of Participants With Day 84 Mortality in the Safety Population

  Day 84

• Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population

  Day 84

• Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population

  Day 42

Study Arms (2)

Dalbavancin

EXPERIMENTAL

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

Drug: Dalbavancin

Standard of Care

ACTIVE COMPARATOR

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

Drug: Standard of Care

Interventions

Dalbavancin DRUG

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

Dalbavancin

Standard of Care DRUG

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

MeSH Terms

Conditions

Endocarditis; Bacteremia

Interventions

dalbavancin; Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Urania Rappo, MD

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: May 12, 2017
• Primary Completion: August 4, 2017
• Study Completion: August 4, 2017
• Last Updated: April 25, 2022
• Results First Posted: September 10, 2018

Record last verified: 2022-03

Locations

US (1)