Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis
![]() |
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: 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:
Allergan
Information provided by (Responsible Party):
Allergan
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | March 21, 2017 | ||||
First Posted Date ICMJE | March 27, 2017 | ||||
Results First Submitted Date ICMJE | August 27, 2018 | ||||
Results First Posted Date ICMJE | September 26, 2018 | ||||
Last Update Posted Date | September 26, 2018 | ||||
Actual Study Start Date ICMJE | May 15, 2017 | ||||
Actual Primary Completion Date | August 31, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population [ Time Frame: Day 42 ] 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.
|
||||
Original Primary Outcome Measures ICMJE |
Clinical response in the Clinically Evaluable (CE) population [ Time Frame: At Day 42 ] Clinical response can be either cure, failure, or indeterminate:
Cure is defined as recovery without need for additional antibiotic therapy.
Failure is defined as:
○ Requirement of additional antibiotic therapy
Indeterminate is defined as:
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis | ||||
Official Title ICMJE | A Phase 2, Multicenter, Open-label, Randomized, Comparator-controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis Known or Suspected to be Due to Gram-positive Organisms | ||||
Brief Summary | This clinical study will be a multi-center, randomized, open-label, active-controlled, parallel-group study comparing dalbavancin to standard of care (SOC) therapy in osteomyelitis. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE | Osteomyelitis | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
1 | ||||
Original Estimated Enrollment ICMJE |
100 | ||||
Actual Study Completion Date ICMJE | August 31, 2017 | ||||
Actual Primary Completion Date | August 31, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
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 | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03091439 | ||||
Other Study ID Numbers ICMJE | 3026-201-008 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Allergan | ||||
Study Sponsor ICMJE | Allergan | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
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 |