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OpenTrials
Completed

NCT Number: NCT05300581

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington Univeristy

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Completion of parenteral antibiotic therapy

    Time frame: 6 weeks patient participation

    Participants will be asked to self-report compliance to the recommended IV antibiotic therapy during a telephone survey performed at completion of antibiotic therapy.

  2. Illicit drug use

    Time frame: 6 weeks patient participation

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

Secondary outcomes

  1. Survey Completion

    Time frame: 3 month chart review

  2. 90-day microbiologic failure

    Time frame: 3 month chart review

  3. 90-day Overdose

    Time frame: 3 month chart review

  4. Sample Size Estimation for Future Study

    Time frame: One year post-enrollment

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2022
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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