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Integrated Care for Infections from Drug Use (CTN0121 Trial)

N/A

Recruiting

Led By Lisa R Metsch, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently be experiencing a severe injection-related infection/SIRI

Be 18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at each of the follow-up times (4, 8 and 12 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial wants to see if a new way of treating patients with severe infections caused by drug use is effective. They will compare this new treatment approach to the usual treatment to see if it helps reduce deaths

Who is the study for?

This trial is for adults over 18 who are hospitalized with severe infections from injecting drugs and have used injection drugs in the past year. They must understand English or Spanish, agree to share health records, and be willing to come back for follow-up visits.

What is being tested?

The study tests a new care approach combining infectious disease and substance use disorder treatments (SIRI Team) against the usual treatment methods. It aims to see if this integrated care reduces death rates and hospital readmissions.

What are the potential side effects?

Since this trial compares different types of healthcare management rather than medications, specific side effects aren't listed like they would be for drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently suffering from a severe infection due to an injection.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at each of the follow-up times (4, 8 and 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at each of the follow-up times (4, 8 and 12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at each of the follow-up times (4, 8 and 12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mortality and Hospital Readmissions

Secondary study objectives

Alcohol use severity

All-cause mortality

Completion of planned antibiotic course for the index infection

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SIRI TeamExperimental Treatment1 Intervention

The study intervention ("SIRI Team") consists of a hospital-based multidisciplinary (ID/SUD consult) team that will provide intensive, integrated care for participants' ID and SUD both during the hospital stay and post-discharge for up to four months post-randomization. The SIRI Team will provide low barrier access to medications and harm reduction services for SUD; streamline ID/SUD treatment; provide longitudinal care with familiar providers; leverage different areas of expertise between physicians, advance practice providers, and patient navigators; and create patient-centered treatment plans, tailored to the individual, and informed by each patient's social circumstances, substance use, and personal goals/desires.

Group II: Treatment as UsualActive Control1 Intervention

Treatment as Usual (TAU) will consist of the current healthcare landscape at each participating hospital site.

0 / 2Eligibility criteria met