Outpatient antibiotic therapy for people who inject opioids
Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids
NA · Washington University School of Medicine · NCT05300581
This study is testing whether giving outpatient antibiotic treatment, along with extra support services, can help people who inject opioids and have serious infections feel better after leaving the hospital.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT05300581 on ClinicalTrials.gov |
What this trial studies
This study explores the feasibility of providing outpatient parenteral antibiotic therapy (OPAT) to individuals with a history of injection drug use, who are typically excluded from such programs. It aims to assess the impact of additional social support services, including case management and health coaching, on the acceptability and effectiveness of OPAT for these patients. The study will gather pilot data to inform a larger-scale trial in the future. Participants will be individuals being discharged from Barnes-Jewish Hospital with serious injection-related infections.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18-100 with a history of injection opioid use and serious injection-related infections, who are being considered for OPAT discharge.
Not a fit: Patients who do not have a history of injection opioid use or those not requiring outpatient antibiotic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment accessibility and outcomes for individuals with opioid use disorder requiring antibiotic therapy.
How similar studies have performed: While small pilot programs have shown promise, this specific approach remains novel and untested on a larger scale.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint Louis, Missouri
- Washington Univeristy — Saint Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Laura Marks, MD, PhD — Washington University School of Medicine
- Study coordinator: Tracey Habrock-Bach, MBA
- Email: habrockt@wustl.edu
- Phone: 314-454-8225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use Disorder