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OpenTrials
Completed

NCT Number: NCT03048643

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).

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Key information

Conditions

Endocarditis, Bacterial Bacterial Infections Bacterial Infections and Mycoses Buprenorphine Cardiovascular Diseases Cardiovascular Infections Chemically-Induced Disorders Endocarditis Heart Diseases Infections Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Opioid-use Disorder Outpatient Parenteral Antibiotic Therapy Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Outpatient parenteral antibiotic therapy

Behavioral

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

Other names: OPAT

Primary outcomes

  1. Illicit drug use

    Time frame: 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 outcomes

  1. Completion of recommended IV antibiotic therapy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Laura Fanucchi

Other

Registry information

Official study title

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

Acronym: CATS-CARE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2017
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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