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
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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
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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Tracking Information | |||||
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First Submitted Date ICMJE | May 9, 2017 | ||||
First Posted Date ICMJE | May 11, 2017 | ||||
Results First Submitted Date ICMJE | August 8, 2018 | ||||
Results First Posted Date ICMJE | September 10, 2018 | ||||
Last Update Posted Date | September 10, 2018 | ||||
Actual Study Start Date ICMJE | May 12, 2017 | ||||
Actual Primary Completion Date | August 4, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population [ Time Frame: Day 84 ] 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.
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Original Primary Outcome Measures ICMJE |
Clinical response at Day 84 in the ITT population [ Time Frame: At Day 84 ] Clinical response can be either success or failure. Success is defined as recovery without need for additional antibiotic therapy.
Failure is defined as:
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 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 | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
2 | ||||
Original Estimated Enrollment ICMJE |
150 | ||||
Actual Study Completion Date ICMJE | August 4, 2017 | ||||
Actual Primary Completion Date | August 4, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | Korea, Republic of, Singapore, Taiwan, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT03148756 | ||||
Other Study ID Numbers ICMJE | DAL-MD-09 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Allergan | ||||
Study Sponsor ICMJE | Allergan | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Allergan | ||||
Verification Date | August 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |