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

January 21, 2019 updated by: Laura Fanucchi

CATS-CARE: 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • OPAT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 weeks after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
12 weeks after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laura Fanucchi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura Fanucchi, MD, University Of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-1001-F1V

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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