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

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ClinicalTrials.gov Identifier: NCT03048643
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Laura Fanucchi, University of Kentucky

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).

Condition or disease Intervention/treatment Phase
Endocarditis, Bacterial Opioid-use Disorder Buprenorphine Outpatient Parenteral Antibiotic Therapy Behavioral: Outpatient parenteral antibiotic therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: CATS-CARE: Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: OPAT




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048643


Contacts
Contact: UK Center on Drug and Alcohol Research 866-933-4859 sharon.walsh@uky.edu

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Laura Fanucchi
Investigators
Principal Investigator: Laura Fanucchi, MD University of Kentucky
Principal Investigator: Sharon Walsh, PhD University of Kentucky

Responsible Party: Laura Fanucchi, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03048643     History of Changes
Other Study ID Numbers: 16-1001-F1V
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Subacute Bacterial
Endocarditis, Bacterial
Bacterial Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Cardiovascular Infections
Infection
Anti-Bacterial Agents
Heart Diseases
Cardiovascular Diseases
Antibiotics, Antitubercular
Analgesics, Opioid
Anti-Infective Agents
Antitubercular Agents
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents