Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis (CATS-CARE)

CATS-CARE: Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis

Hospitalizations for severe infections associated with opioid use disorder (OUD), such as infective endocarditis (IE), have doubled in the US over the past decade and are frequently prolonged and resource-intensive. Once medically stabilized, persons with IE but without drug use typically enroll in outpatient parenteral antibiotic therapy (OPAT), while persons with IE and OUD are kept in the hospital for the duration of therapy (often 6 weeks or more) largely due to concerns of ongoing drug use. Unfortunately, hospitalization for IE with OUD infrequently includes evidence-based medication-assisted treatment (MAT) with buprenorphine or methadone to address the OUD, despite the strong evidence that MAT decreases illicit drug use and mortality. Enrolling hospitalized persons with IE due to OUD into comprehensive MAT (i.e., buprenorphine + counseling) while inpatient, and providing an intensive transitional outpatient care program supporting MAT, may support provision of outpatient IV antibiotic therapy and be cost effective. The primary aim of this pilot randomized clinical trial is to evaluate the equivalence of current practice plus buprenorphine (keeping patients with IE due to opioid use disorder in the hospital for the full duration of antibiotic treatment) compared to OPAT plus buprenorphine (discharge with outpatient treatment once medically stable).

Study Overview

• Status: Completed
• Conditions: Endocarditis, Bacterial; Opioid-use Disorder; Outpatient Parenteral Antibiotic Therapy; Buprenorphine
• Intervention / Treatment: Behavioral: Outpatient parenteral antibiotic therapy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• meeting OUD by DSM-V criteria
• have IE by Duke's criteria
• candidates for outpatient treatment with buprenorphine
• accepting of buprenorphine treatment
• anticipated to be discharged home after medically stabilized
• requiring ≥ 2 weeks of IV antibiotic therapy
• having ≥ 1 week of IV antibiotic therapy remaining at the time of medical readiness for discharge (as defined by the primary clinical team),
• and providing informed consent.

Exclusion Criteria:

• presence of stroke or central nervous system involvement
• clinically active embolic sequelae (e.g. pulmonary sepsis, mycotic aneurysms, splenic abscesses)
• TV treated surgically or endovascularly (AngioVac)
• presence of osteomyelitis
• fungal IE
• patients who require inpatient physical rehabilitation determined by physical or occupational therapy assessment
• current pregnancy
• current severe methamphetamine, cocaine, alcohol or benzodiazepine use disorders by DSM-V criteria
• currently enrolled in ongoing MAT for OUD
• hypersensitivity or allergy to buprenorphine
• chronic pain requiring opioids
• class III or IV heart failure
• cirrhosis
• end stage renal disease
• other significant screening laboratory/medical/psychiatric/psychosocial condition that may prevent the volunteer from safely participating in the study in the opinion of the investigator (e.g. currently suicidal)
• pending legal action that could interfere with study participation
• living more than a 45-minute drive from UK given the intense outpatient component to the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: OPAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Illicit drug use	Participants will be asked by their clinician to self report illicit drug use at their follow up visit 12 weeks after discharge	12 weeks after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of recommended IV antibiotic therapy	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	12 weeks after discharge

Collaborators and Investigators

• Sponsor: Laura Fanucchi
• Investigators: Principal Investigator: Laura Fanucchi, MD, University of Kentucky

Publications and helpful links

General Publications

• Fanucchi LC, Walsh SL, Thornton AC, Nuzzo PA, Lofwall MR. Outpatient Parenteral Antimicrobial Therapy Plus Buprenorphine for Opioid Use Disorder and Severe Injection-related Infections. Clin Infect Dis. 2020 Mar 3;70(6):1226-1229. doi: 10.1093/cid/ciz654.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): October 2, 2018
• Study Completion (Actual): October 2, 2018

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Heart Diseases; Cardiovascular Diseases; Substance-Related Disorders; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Narcotic-Related Disorders; Cardiovascular Infections; Opioid-Related Disorders; Endocarditis, Bacterial; Endocarditis; Endocarditis, Subacute Bacterial; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 16-1001-F1V

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No