Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis (CATS-CARE)
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|ClinicalTrials.gov Identifier: NCT03048643|
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : May 8, 2017
|Condition or disease||Intervention/treatment|
|Endocardits, Bacterial Opioid-use Disorder Buprenorphine Outpatient Parenteral Antibiotic Therapy||Drug: Buprenorphine/naloxone Other: Outpatient parenteral antibiotic therapy|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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 29, 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Current practice plus buprenorphine
Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy for infective endocarditis according to usual care.
Subjects in both groups will receive buprenorphine/naloxone according to published guidelines for induction, stabilization, and maintenance dosing.
Experimental: OPAT plus buprenorphine
Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy via outpatient parenteral antibiotic therapy (OPAT).
Subjects in both groups will receive buprenorphine/naloxone according to published guidelines for induction, stabilization, and maintenance dosing.Other: Outpatient parenteral antibiotic therapy
Subjects randomized to OPAT plus buprenorphine will complete IV antibiotic therapy for infective endocarditis as an outpatient according to published guidelines.
Other Name: OPAT
- Number of days of illicit drug use in the [ Time Frame: 12 weeks after discharge ]
- Completion of recommended IV antibiotic therapy [ Time Frame: Total course completed within 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
|Contact: UK Center on Drug and Alcohol Researchfirstname.lastname@example.org|
|United States, Kentucky|
|University of Kentucky||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Laura Fanucchi, MD||University of Kentucky|
|Principal Investigator:||Sharon Walsh, PhD||University of Kentucky|