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

NCT05300581 | Completed

• 1 other identifier: 202110063
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  6 weeks patient participation

• Illicit drug use

  Participants will have urine drug screens performed at clinic follow-up visit while on OPAT.

  6 weeks patient participation

Secondary Outcomes (4)

• Survey Completion

  3 month chart review

• 90-day microbiologic failure

  3 month chart review

• 90-day Overdose

  3 month chart review

• Sample Size Estimation for Future Study

  One year post-enrollment

Study Arms (1)

Observational Arm

OTHER

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.

Other: OPAT for PWID

Interventions

OPAT for PWID OTHER

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.

Observational Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking males and females
• years of age
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington Univeristy

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Laura Marks, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: March 16, 2022
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)