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New care model aims to save lives of drug users with severe infections

NCT ID NCT05688423

Disease control Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special care team that combines treatment for severe injection-related infections and substance use disorders can improve outcomes. 480 hospitalized adults who inject drugs will either receive this integrated care or usual treatment. The main goal is to see if the integrated approach lowers death rates and hospital readmissions within 4 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Integrated care team (behavioral intervention combining infectious disease and substance use disorder treatment)
What this could lead to
If successful, this approach could reduce deaths and hospital readmissions for people with severe injection-related infections and substance use disorders.
What could go wrong
This is a single study with 480 participants, and results may not apply to all hospitals or patients. The intervention is complex and may be hard to replicate widely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 480 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Harm Reduction substance-related disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Injection site infection Substance use disorders

Contacts and locations

Locations

  • Tampa General Hospital

    Tampa, Florida, 33601, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Miami - Jackson Memorial Hospital

    Miami, Florida, 33136, United States

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87106, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Utah Hospital

    Salt Lake City, Utah, 84132, United States

More trials for these conditions

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