Status:
RECRUITING
Continuum of Care in Hospitalized Patients With Opioid/Stimulant Use Disorder and Infectious Complications From Drug Use
Lead Sponsor:
Elana Rosenthal
Collaborating Sponsors:
Emory University
George Washington University
Conditions:
Opioid Use Disorder
Injection Related Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a two-group randomized controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of an Integrated infectious diseases/Substance Use Disorder outpatient cl...
Detailed Description
This is a phase III two arm randomized controlled trial to determine the impact and Integrated infectious diseases (ID) and Substance Use Disorder outpatient clinic (IC) compared to treatment as usual...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine)
- Injection opioid or stimulant use in past 90 days - per patient self-report
- Active suspected or confirmed qualifying infection (see list) at time of admission.
- Qualifying infections:
- Non-vertebral osteomyelitis
- Vertebral osteomyelitis or discitis
- Epidural, subdural, or extradural abscess
- Intracranial or intraspinal abscess
- Native joint septic arthritis
- Prosthetic joint septic arthritis
- Blood stream infection (bacterial or fungal)
- Native valve Endocarditis
- Prosthetic valve endocarditis
- Cardiac Implantable electronic device infection
- Infectious pseudoaneurysm and aneurysm
- Infected vascular graft
- Septic venous thrombosis
- Skin and Soft tissue infection (cellulitis, skin abscess, necrotizing fasciitis)
- Infected skin ulcer
- Orthopedic hardware infection
- Muscle abscess/myositis
- Central nervous system infection (bacterial or fungal)
- Bacterial or fungal ophthalmologic infection
- Other abscess
- Pulmonary septic emboli
- Other acute bacterial or fungal infection deemed appropriate by site study team
Exclusion
- 1\. Infection due to a cause other than injection drug use, per determination of a site PI.
- 2\. Inability to provide consent due to circumstance (e.g., sedated, intubated), language, or cognitive impairment.
- 3\. Unwilling to provide informed consent 4. Unable to receive potential interventions due to geography 5. On comfort measures or planned for discharge to hospice care 6. Incarcerated at the time of hospitalization 7. Other criteria at the discretion of the site investigator
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2027
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT06513156
Start Date
October 1 2024
End Date
July 30 2027
Last Update
October 31 2025
Active Locations (4)
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1
George Washington University
Washington D.C., District of Columbia, United States, 20052
2
Emory University
Atlanta, Georgia, United States, 30322
3
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
4
West Virginia University
Morgantown, West Virginia, United States, 26506