Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis (CATS-CARE)
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|ClinicalTrials.gov Identifier: NCT03048643|
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endocarditis, Bacterial Opioid-use Disorder Buprenorphine Outpatient Parenteral Antibiotic Therapy||Behavioral: Outpatient parenteral antibiotic therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||CATS-CARE: Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||October 2, 2018|
|Actual Study Completion Date :||October 2, 2018|
No Intervention: Standard of Care
Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy for infective endocarditis according to usual care.
Experimental: Outpatient Parenteral Antibiotic Therapy
Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy via outpatient parenteral antibiotic therapy (OPAT).
Behavioral: Outpatient parenteral antibiotic therapy
Subjects randomized to OPAT will complete IV antibiotic therapy for infective endocarditis as an outpatient according to published guidelines.
Other Name: OPAT
- Illicit drug use [ Time Frame: 12 weeks after discharge ]Participants will be asked by their clinician to self report illicit drug use at their follow up visit 12 weeks after discharge
- Completion of recommended IV antibiotic therapy [ Time Frame: 12 weeks after discharge ]Participants will be asked by their clinician to self report compliance to the recommended IV antibiotic therapy at their follow up visit 12 weeks after discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048643
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Laura Fanucchi, MD||University of Kentucky|
|Principal Investigator:||Sharon Walsh, PhD||University of Kentucky|