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

Bacteremia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03148756
• Other study ID #: DAL-MD-09
• Status: Terminated
• Phase: Phase 2
• Start date: May 12, 2017
• Est. completion date: August 4, 2017

Study information

• Verified date: March 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 4, 2017
• Est. primary completion date: August 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Endocarditis
• Endocarditis, Bacterial

Intervention

Drug:
• Dalbavancin
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.

Locations

Country	Name	City	State
United States	Midway Immunology and Research Center	Fort Pierce	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population	Clinical outcome 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.	Day 42
Secondary	Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population	Clinical outcome 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.	Day 42
Secondary	Number of Participants With Day 84 Mortality in the Safety Population	Day 84 mortality was measured by the number of deaths up to Day 84.	Day 84
Secondary	Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population	Clinical outcome was either success or failure/relapse. 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.	Day 84
Secondary	Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population	Clinical outcome 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.	Day 42
Secondary	Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population	Clinical outcome 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.	Day 84
Secondary	Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population	Clinical outcome 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.	Day 42
Secondary	Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population	Clinical outcome 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.	Day 84
Secondary	Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population	Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.	Day 42
Secondary	Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population	Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.	Day 84
Secondary	Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population	Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.	Day 42
Secondary	Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population	Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.	Day 84