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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03148756
Recruitment Status : Terminated (Study stopped due to business reasons.)
First Posted : May 11, 2017
Results First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Endocarditis
Bacteremia
Interventions Drug: Dalbavancin
Drug: Standard of Care
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Period Title: Overall Study
Started 0 2
Completed 0 1
Not Completed 0 1
Reason Not Completed
Study Terminated             0             1
Arm/Group Title Dalbavancin Standard of Care Total
Hide Arm/Group Description Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 0 2 2
Hide Baseline Analysis Population Description
All randomized participants.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
<=18 years 0
Between 18 and 65 years 0
>=65 years 0
[1]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
Female 0
Male 0
[1]
Measure Analysis Population Description: 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 2 participants 2 participants
White 0
2
 100.0%
2
 100.0%
1.Primary Outcome
Title Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population
Hide Description 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.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
Success
1
 100.0%
Failure
0
   0.0%
2.Secondary Outcome
Title Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population
Hide Description 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.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: percentage of participants
100
3.Secondary Outcome
Title Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population
Hide Description 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.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: percentage of participants
100
4.Secondary Outcome
Title Number of Participants With Day 84 Mortality in the Safety Population
Hide Description Day 84 mortality was measured by the number of deaths up to Day 84.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population
Hide Description 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.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: percentage of participants
100
6.Secondary Outcome
Title Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population
Hide Description 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.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: percentage of participants
100
7.Secondary Outcome
Title Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population
Hide Description 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.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: percentage of participants
100
8.Secondary Outcome
Title Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population
Hide Description 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.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: percentage of participants
100
9.Secondary Outcome
Title Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population
Hide Description 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.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: percentage of participants
100
10.Secondary Outcome
Title Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population
Hide Description Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: percentage of participants
100
11.Secondary Outcome
Title Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population
Hide Description Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: percentage of participants
100
12.Secondary Outcome
Title Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population
Hide Description Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: percentage of participants
100
13.Secondary Outcome
Title Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population
Hide Description Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
Overall Number of Participants Analyzed 0 1
Measure Type: Number
Unit of Measure: percentage of participants
100
Time Frame Up to 84 Days
Adverse Event Reporting Description 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.
 
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8. Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
All-Cause Mortality
Dalbavancin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/2 (0.00%) 
Hide Serious Adverse Events
Dalbavancin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dalbavancin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   1/2 (50.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  0/0  1/2 (50.00%) 
1
Term from vocabulary, MedDRA 20.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03148756    
Other Study ID Numbers: DAL-MD-09
First Submitted: May 9, 2017
First Posted: May 11, 2017
Results First Submitted: August 8, 2018
Results First Posted: September 10, 2018
Last Update Posted: September 10, 2018