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Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids

Primary Purpose

Opioid Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OPAT for PWID
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English speaking males and females
  • 18-100 years of age
  • Being considered for discharge from Barnes-Jewish Hospital on OPAT* (PICC/Midline only) for a serious injection related infection including; endocarditis, osteomyelitis, discitis, septic arthritis, epidural abscess, or S. aureus bacteremia. *Note that outside of this protocol patients with a history of substance use disorder are considered for discharge on OPAT to skilled nursing facilities or other health-care locations such as BJH extended care. Patients being considered for discharge on OPAT to any of these locations are eligible for inclusion.
  • History of injection opioid use within the last 1 year
  • Evaluated by the joint toxicology/psychiatry addiction medicine consult service during the current inpatient admission
  • Started or maintained on medications for opioid use disorder (MOUD) of either methadone, buprenorphine or buprenorphine-naloxone during admission to Barnes-Jewish Hospital
  • Have a scheduled follow-up for continuation of medications for opioid use disorder in place prior to discharge. For patients on methadone this should include a scheduled appointment at a methadone clinic, or for patients on buprenorphine this can include a plan for ongoing buprenorphine/ buprenorphine-naloxone based therapy at the Washington University Infectious Diseases Clinic.
  • Have met with a health coach or a member of the Bridge To Health team during their inpatient hospitalization and agree to ongoing supportive counseling after discharge.
  • Be willing and able to attend in-person clinic visits within 60 days post-discharge at the Washington University Infectious Diseases Clinic.
  • Have a working phone number with active voicemail, running water and electricity.

Exclusion Criteria:

  • Prisoner status
  • Unable to provide own informed consent
  • Current homelessness
  • Other house-hold members reported as having active untreated substance use disorders
  • Unable to attend outpatient appointments. This may include patients who are from rural areas where transportation vouchers may not provide sufficient means of making it to follow-up appointments, or other disability that would preclude transportation (paralysis, broken limbs) where the patient is unable to provide specific details as to how they would arrive at clinic appointments.

Sites / Locations

  • Washington UniveristyRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Observational Arm

Arm Description

Patients with a history of injection opioid use will receive home OPAT while also receiving substance use disorder care including medications for opioid use disorder and multidisciplinary health coach and case management support.

Outcomes

Primary Outcome Measures

Completion of parenteral antibiotic therapy
Participants will be asked to self-report compliance to the recommended IV antibiotic therapy during a telephone survey performed at completion of antibiotic therapy.
Illicit drug use
Participants will have urine drug screens performed at clinic follow-up visit while on OPAT.

Secondary Outcome Measures

Survey Completion
90-day microbiologic failure
90-day Overdose
Sample Size Estimation for Future Study

Full Information

First Posted
March 18, 2022
Last Updated
March 18, 2022
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05300581
Brief Title
Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids
Official Title
Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with a history of injection drug use are historically excluded from home outpatient parenteral antibiotic therapy programs. Recent small pilot programs have demonstrated that these patients may be safely included in home OPAT programs when they are provided with medications for opioid use disorder such as suboxone or methadone. However nothing is known about the effect of additional social support services including case management and health coach navigation on the feasibility and acceptibility of home OPAT programs for persons who inject drugs. This observational study will provide pilot data on the feasibility of such a program in anticipation of a larger scale trial.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observational Arm
Arm Type
Other
Arm Description
Patients with a history of injection opioid use will receive home OPAT while also receiving substance use disorder care including medications for opioid use disorder and multidisciplinary health coach and case management support.
Intervention Type
Other
Intervention Name(s)
OPAT for PWID
Intervention Description
Observational: Patients with a history of injection opioid use will receive home OPAT while also receiving substance use disorder care including medications for opioid use disorder and multidisciplinary health coach and case management support.
Primary Outcome Measure Information:
Title
Completion of parenteral antibiotic therapy
Description
Participants will be asked to self-report compliance to the recommended IV antibiotic therapy during a telephone survey performed at completion of antibiotic therapy.
Time Frame
6 weeks patient participation
Title
Illicit drug use
Description
Participants will have urine drug screens performed at clinic follow-up visit while on OPAT.
Time Frame
6 weeks patient participation
Secondary Outcome Measure Information:
Title
Survey Completion
Time Frame
3 month chart review
Title
90-day microbiologic failure
Time Frame
3 month chart review
Title
90-day Overdose
Time Frame
3 month chart review
Title
Sample Size Estimation for Future Study
Time Frame
One year post-enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking males and females 18-100 years of age Being considered for discharge from Barnes-Jewish Hospital on OPAT* (PICC/Midline only) for a serious injection related infection including; endocarditis, osteomyelitis, discitis, septic arthritis, epidural abscess, or S. aureus bacteremia. *Note that outside of this protocol patients with a history of substance use disorder are considered for discharge on OPAT to skilled nursing facilities or other health-care locations such as BJH extended care. Patients being considered for discharge on OPAT to any of these locations are eligible for inclusion. History of injection opioid use within the last 1 year Evaluated by the joint toxicology/psychiatry addiction medicine consult service during the current inpatient admission Started or maintained on medications for opioid use disorder (MOUD) of either methadone, buprenorphine or buprenorphine-naloxone during admission to Barnes-Jewish Hospital Have a scheduled follow-up for continuation of medications for opioid use disorder in place prior to discharge. For patients on methadone this should include a scheduled appointment at a methadone clinic, or for patients on buprenorphine this can include a plan for ongoing buprenorphine/ buprenorphine-naloxone based therapy at the Washington University Infectious Diseases Clinic. Have met with a health coach or a member of the Bridge To Health team during their inpatient hospitalization and agree to ongoing supportive counseling after discharge. Be willing and able to attend in-person clinic visits within 60 days post-discharge at the Washington University Infectious Diseases Clinic. Have a working phone number with active voicemail, running water and electricity. Exclusion Criteria: Prisoner status Unable to provide own informed consent Current homelessness Other house-hold members reported as having active untreated substance use disorders Unable to attend outpatient appointments. This may include patients who are from rural areas where transportation vouchers may not provide sufficient means of making it to follow-up appointments, or other disability that would preclude transportation (paralysis, broken limbs) where the patient is unable to provide specific details as to how they would arrive at clinic appointments.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tracey Habrock-Bach, MBA
Phone
314-454-8225
Email
habrockt@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Marks, MD, PhD
Phone
314-454-8225
Email
marks@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Marks, MD, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Univeristy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Marks, MD,PhD
Email
marks@wustl.edu
First Name & Middle Initial & Last Name & Degree
Tracey Habrock-Bach, MBA
Phone
314-273-6075
Email
habrockt@wustl.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids

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