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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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Page 1 of 1 (4 locations)

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