Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis

NCT03048643 | Completed

• 1 other identifier: 16-1001-F1V
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Endocarditis, Bacterial; Opioid-use Disorder; Buprenorphine; Outpatient Parenteral Antibiotic Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Completion of recommended IV antibiotic therapy

  12 weeks after discharge

Study Arms (2)

Standard of Care

NO INTERVENTION

Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy for infective endocarditis according to usual care.

Outpatient Parenteral Antibiotic Therapy

EXPERIMENTAL

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

Interventions

Outpatient parenteral antibiotic therapy BEHAVIORAL

Subjects randomized to OPAT will complete IV antibiotic therapy for infective endocarditis as an outpatient according to published guidelines.

Also known as: OPAT

Outpatient Parenteral Antibiotic Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laura Fanucchi: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• 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.

  PMID: 31342057 DERIVED

MeSH Terms

Conditions

Endocarditis, Bacterial; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Cardiovascular Infections; Cardiovascular Diseases; Endocarditis; Heart Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Laura Fanucchi, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Sharon Walsh, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 9, 2017
• Study Start: March 1, 2017
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)