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Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis

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ClinicalTrials.gov Identifier: NCT03091439
Recruitment Status : Terminated (Business decision outlined by the corporation.)
First Posted : March 27, 2017
Results First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteomyelitis
Interventions Drug: Dalbavancin
Drug: Standard of Care
Enrollment 1
Recruitment Details Although this was a planned multi-center study, the study was terminated and only one investigative site in the United States enrolled a participant.
Pre-assignment Details  
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8. Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Period Title: Overall Study
Started 1 0
Completed 0 0
Not Completed 1 0
Reason Not Completed
Study Terminated by the Sponsor             1             0
Arm/Group Title Dalbavancin Standard of Care Total
Hide Arm/Group Description Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8. Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
All Randomized Participants. 1 participant was enrolled in the Dalbavancin arm and 0 participants were enrolled in the Standard-of-Care arm. Due to confidentiality considerations, baseline data is not being provided to protect participant privacy.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Race (NIH/OMB)  
Number Analyzed 0 participants 0 participants 0 participants
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
1.Primary Outcome
Title Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population
Hide Description Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency. The number of participants in each response category is reported.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
CE population included all participants in the mITT Population who received ≥ 1 dose of dalbavancin or ≥ 2 weeks of comparator and ≤ 1 dose of another (non-study) systemic antibiotic with activity against the causative organism for an indication other than osteomyelitis. No participants were enrolled in the SOC arm.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
Cure
1
 100.0%
0
Failure
0
   0.0%
0
Indeterminate
0
   0.0%
0
2.Secondary Outcome
Title Number of Participants With Clinical Improvement at Day 28 in the Modified Intent-to-Treat (mITT) Population
Hide Description Clinical improvement was based on an assessment of pain and/or point tenderness compared to Baseline and assessment of inflammation as measured by C-reactive Protein (CRP). Clinical improvement was defined as no worsening of pain from Baseline, if present, and improvement in inflammation.
Time Frame Baseline (Day 0) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population including all randomized participants who received randomized medication and met criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded. No participants were enrolled in the SOC arm.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
3.Secondary Outcome
Title Number of Participants With Clinical Improvement at Day 28 in the CE Population
Hide Description Clinical improvement was based on an assessment of pain and/or point tenderness compared to Baseline and assessment of inflammation as measured by C-reactive Protein (CRP). Clinical improvement was defined as no worsening of pain from Baseline, if present, and improvement in inflammation.
Time Frame Baseline (Day 0) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
CE population included all participants in the mITT Population who received ≥ 1 dose of dalbavancin or ≥ 2 weeks of comparator and ≤ 1 dose of another (non-study) systemic antibiotic with activity against the causative organism for an indication other than osteomyelitis. No participants were enrolled in the SOC arm.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
0
4.Secondary Outcome
Title Number of Participants With Clinical Response at Day 42 in the mITT Population
Hide Description Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants who received randomized medication and met the criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded. No participants were enrolled in the SOC arm.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Overall Number of Participants Analyzed 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
Cure
1
 100.0%
0
Failure
0
   0.0%
0
Indeterminate
0
   0.0%
0
5.Secondary Outcome
Title Number of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population
Hide Description Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
micro-mITT included participants in the mITT Population with a Gram-positive pathogen isolated from blood and/or bone specimen. No participants met criteria for the micro-mITT population.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants With Clinical Response at Day 180 in the mITT and CE Populations
Hide Description Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study prior to the Day 180 visit, the participant enrolled did not have data collected for this visit, but did have an early termination visit prior to Day 180.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants With Clinical Response at Day 365 in the mITT and CE Populations
Hide Description Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.
Time Frame Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study prior to the Day 180 visit, the participant enrolled did not have data collected for the visits at Day 180 or Day 365, but did have an early termination visit prior to Day 180.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With Clinical Response by Pathogen at Day 42 in the CE Population
Hide Description Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
There were no pathogens identified in this study; the participant enrolled had no pathogens detected on blood culture, and the optional bone biopsy was not performed.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Number of Participants With Clinical Response by Pathogen at Day 180 in the CE Population
Hide Description Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
There were no pathogens identified in this study; the participant enrolled had no pathogens detected on blood culture, and the optional bone biopsy was not performed.
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description:
Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline to last visit (Up to Day 108)
Adverse Event Reporting Description No participants were enrolled in the SOC arm.
 
Arm/Group Title Dalbavancin Standard of Care
Hide Arm/Group Description Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8. Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
All-Cause Mortality
Dalbavancin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Dalbavancin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events 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   0/1 (0.00%)   0/0 
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: NCT03091439     History of Changes
Other Study ID Numbers: 3026-201-008
First Submitted: March 21, 2017
First Posted: March 27, 2017
Results First Submitted: August 27, 2018
Results First Posted: September 26, 2018
Last Update Posted: September 26, 2018