Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis

Not Applicable

Completed

• Conditions: Endocarditis, Bacterial; Opioid-use Disorder; Buprenorphine; Outpatient Parenteral Antibiotic Therapy
• Interventions: Behavioral: Outpatient parenteral antibiotic therapy

• Registration Number: NCT03048643
• Lead Sponsor: Laura Fanucchi

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Study Start: 2017-03-01
• Primary Completion: 2018-10-02
• Study Completion: 2018-10-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient Parenteral Antibiotic Therapy	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).

Primary Outcome Measures

Name	Time	Method
Illicit drug use	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

Secondary Outcome Measures

Name	Time	Method
Completion of recommended IV antibiotic therapy	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

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States