← Back to Search

SIRI Team for Injection Site Infection (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

CTN0121 Trial 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.Check my eligibility

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.See study design

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.

CTN0121 Trial 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.

CTN0121 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mortality and Hospital Readmissions

Secondary outcome measures

Alcohol use severity

All-cause mortality

Completion of planned antibiotic course for the index infection

+6 more

CTN0121 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

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,446,779 Total Patients Enrolled

University of MiamiOTHER

902 Previous Clinical Trials

409,596 Total Patients Enrolled

Emory UniversityOTHER

1,640 Previous Clinical Trials

2,560,177 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential candidates able to apply for participation in this ongoing trial?

"Indeed, the information provided on clinicaltrials.gov confirms that this particular clinical trial is actively seeking eligible participants. The initial posting of the trial occurred on January 5th, 2024, and it was most recently updated on January 25th, 2024."

Answered by AI

Across how many different sites is this clinical trial currently being conducted?

"At present, there are six active enrollment sites for this study. These locations include Birmingham, Miami, Albuquerque, and an additional three undisclosed sites. It is advised to choose the nearest site to minimize travel requirements for potential participants."

Answered by AI

What is the current number of participants being recruited for this clinical investigation?

"To successfully conduct this study, a total of 480 eligible participants who meet the trial's inclusion criteria are needed. The Emmes Company, LLC will oversee the trial and it will take place at multiple locations, including the University of Alabama at Birmingham in Birmingham, Alabama and the University of Miami - Jackson Memorial Hospital in Miami, New mexico."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Lisa Metsch 2024. "Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05688423.

All > Infectious Disease