Trial Outcomes & Findings for 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 (NCT NCT03148756)

NCT ID: NCT03148756

Last Updated: 2022-04-25

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: Day 84
• Results posted on: 2022-04-25

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	0	2
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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.
Overall Study Study Terminated	0	1

Baseline Characteristics

Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.

Baseline characteristics by cohort

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=2 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	—	0 Participants Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
Age, Categorical Between 18 and 65 years	—	—	0 Participants Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
Age, Categorical >=65 years	—	—	0 Participants Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
Sex: Female, Male Female	—	—	0 Participants Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
Sex: Female, Male Male	—	—	0 Participants Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.
Race/Ethnicity, Customized White	0 Participants	2 Participants n=2 Participants	2 Participants n=2 Participants

PRIMARY outcome

Timeframe: Day 84

Population: ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.

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.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population Success	—	1 Participants
Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population Failure	—	0 Participants

SECONDARY outcome

Timeframe: Day 42

Population: ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.

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.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population	—	100 percentage of participants

SECONDARY outcome

Timeframe: Day 42

Population: CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.

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.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population	—	100 percentage of participants

SECONDARY outcome

Timeframe: Day 84

Population: Safety Population included all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.

Day 84 mortality was measured by the number of deaths up to Day 84.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Number of Participants With Day 84 Mortality in the Safety Population	—	0 Participants

SECONDARY outcome

Timeframe: Day 84

Population: CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.

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.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population	—	100 percentage of participants

SECONDARY outcome

Timeframe: Day 42

Population: ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.

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.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population	—	100 percentage of participants

SECONDARY outcome

Timeframe: Day 84

Population: ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.

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.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population	—	100 percentage of participants

SECONDARY outcome

Timeframe: Day 42

Population: CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.

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.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population	—	100 percentage of participants

SECONDARY outcome

Timeframe: Day 84

Population: CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.

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.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population	—	100 percentage of participants

SECONDARY outcome

Timeframe: Day 42

Population: ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.

Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population	—	100 percentage of participants

SECONDARY outcome

Timeframe: Day 84

Population: ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.

Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population	—	100 percentage of participants

SECONDARY outcome

Timeframe: Day 42

Population: CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.

Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population	—	100 percentage of participants

SECONDARY outcome

Timeframe: Day 84

Population: CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.

Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.

Outcome measures

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=1 Participants Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population	—	100 percentage of participants

Adverse Events

Dalbavancin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dalbavancin Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.	Standard of Care n=2 participants at risk Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Blood and lymphatic system disorders Anaemia	— 0/0 • Up to 84 Days There were no participants enrolled in the Dalbavancin arm. Due to the low number of participants enrolled at only 1 site, 0 participants are reported for SAEs due to the risk of identification of a person.	50.0% 1/2 • Up to 84 Days There were no participants enrolled in the Dalbavancin arm. Due to the low number of participants enrolled at only 1 site, 0 participants are reported for SAEs due to the risk of identification of a person.

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review.
• Publication restrictions are in place

Restriction type: OTHER