Back to results

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

Primary Purpose

Endocarditis, Bacterial, Opioid-use Disorder, Buprenorphine

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Outpatient parenteral antibiotic therapy

About this trial

This is an interventional health services research trial for Endocarditis, Bacterial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Outpatient Parenteral Antibiotic Therapy

Arm Description

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

Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy via outpatient parenteral antibiotic therapy (OPAT).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Completion of recommended IV antibiotic therapy

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

Full Information

NCT ID

NCT03048643

First Posted

February 2, 2017

Last Updated

January 21, 2019

Sponsor

Laura Fanucchi

1. Study Identification

Unique Protocol Identification Number

NCT03048643

Brief Title

Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis

Acronym

CATS-CARE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

October 2, 2018 (Actual)

Study Completion Date

October 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Laura Fanucchi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

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

Arm Title

Outpatient Parenteral Antibiotic Therapy

Arm Type

Experimental

Arm Description

Subjects will receive medication-assisted treatment for opioid use disorder and will complete IV antibiotic therapy via outpatient parenteral antibiotic therapy (OPAT).

Intervention Type

Behavioral

Intervention Name(s)

Outpatient parenteral antibiotic therapy

Other Intervention Name(s)

OPAT

Intervention Description

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

Primary Outcome Measure Information:

Title

Illicit drug use

Description

Participants will be asked by their clinician to self report illicit drug use at their follow up visit 12 weeks after discharge

Time Frame

12 weeks after discharge

Secondary Outcome Measure Information:

Title

Completion of recommended IV antibiotic therapy

Description

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

Time Frame

12 weeks after discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Fanucchi, MD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sharon Walsh, PhD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31342057

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.

Results Reference

derived

Learn more about this trial

Combining Opioid Addiction Treatment Services With CARe for Infectious Endocarditis

We'll reach out to this number within 24 hrs