Clinical trial NCT03048643: Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis
Official title: CATS-CARE: Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endocarditis, Bacterial
Opioid-use Disorder
Buprenorphine
Outpatient Parenteral Antibiotic Therapy
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Illicit drug use
timeFrame: 12 weeks after discharge
Secondary outcomes:
measure: Completion of recommended IV antibiotic therapy
timeFrame: 12 weeks after discharge
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Laura Fanucchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Sharon Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.