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Search / Trial NCT05688423

Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients

Launched by COLUMBIA UNIVERSITY · Jan 17, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Substance Use Disorders Severe Injection Related Infections Randomized Controlled Trial Hospital Based Care Harm Reduction

ClinConnect Summary

This clinical trial is looking at how well a special care team can help hospitalized patients who have serious infections from injecting drugs and also struggle with substance use disorders. The main goal is to find out if this integrated approach can help patients live longer and reduce the number of times they have to return to the hospital. If you are over 18 years old, currently in a hospital for a severe injection-related infection, and have used injected drugs in the past year, you might be eligible to participate in this trial.

If you join the study, you will receive care from a dedicated team that focuses on both your infection and substance use issues. Researchers will compare your health outcomes with those of patients receiving standard treatment. Participation will involve providing informed consent and attending follow-up visits to track your recovery. It’s important to remember that individuals with serious cognitive impairments, those currently in jail, or those unable to give consent will not be eligible for the study. This trial aims to improve care for people facing both severe infections and addiction challenges.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Be admitted to a participating hospital at the time of randomization
  • Be 18 years of age or older
  • Currently be experiencing a severe injection-related infection/SIRI or suspected SIRI
  • Have an indication of injecting drugs in the prior year
  • Provide informed consent
  • Ability to communicate in English
  • Provide sufficient locator information
  • Sign a HIPAA form and/or EHR release to facilitate record abstraction
  • Report being willing to return for follow-up visits
  • Exclusion Criteria:
  • All individuals meeting any of the exclusion criteria will be excluded from study participation. Specifically, individuals will be excluded from participation if they:
  • have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
  • (or their legal guardian/representative) are unable or unwilling to give written informed consent
  • are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities
  • are terminated via site principal investigator decision with agreement from one of the study lead investigators.

About Columbia University

Columbia University, a prestigious Ivy League institution located in New York City, is a leading sponsor of clinical trials dedicated to advancing medical research and improving patient care. With a robust network of research facilities and a commitment to innovation, Columbia University collaborates with a diverse range of healthcare professionals and researchers to explore groundbreaking therapies and treatment methodologies. The university's clinical trials encompass various fields, including oncology, neurology, and public health, aiming to translate scientific discoveries into effective clinical applications. Columbia University is dedicated to maintaining the highest ethical standards and regulatory compliance, ensuring the safety and well-being of trial participants while contributing to the global body of medical knowledge.

Locations

Philadelphia, Pennsylvania, United States

Birmingham, Alabama, United States

Birmingham, Alabama, United States

Tampa, Florida, United States

Salt Lake City, Utah, United States

Albuquerque, New Mexico, United States

Philadelphia, Pennsylvania, United States

Miami, Florida, United States

Patients applied

0 patients applied

Trial Officials

Lisa R Metsch, PhD

Principal Investigator

Columbia University

David P Serota, MD, MSc

Principal Investigator

University of Miami

Daniel J Feaster, PhD

Principal Investigator

University of Miami

Carlos del Rio, MD

Principal Investigator

Emory University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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