Injection Site InfectionCTN0121NCT05688423
Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients
A study testing SIRI Team and Treatment as Usual in people with Injection Site Infection and Substance Use Disorders, run by Columbia University at 6 sites in United States.
Trial summary
The goal of this clinical trial is to test the effectiveness of an integrated infectious disease/substance use disorder (SUD) clinical team intervention approach in patients hospitalized with severe injection-related infections (SIRI) who use drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injection Site Infection, Substance Use Disorders
- What is being tested?
- SIRI Team and Treatment as Usual
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 6 sitesUnited States
- Study dates
- 5 Jan 2024to 3 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87106
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Miami - Jackson Memorial Hospital
Miami, Florida, 33136
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah Hospital
Salt Lake City, Utah, 84132
Tampa General Hospital
Tampa, Florida, 33601
About this study
The goal of this clinical trial is to test the effectiveness of an integrated infectious disease/substance use disorder (SUD) clinical team intervention approach in patients hospitalized with severe injection-related infections (SIRI) who use drugs. The main question this study aims to answer is whether this intervention approach will be associated with lower mortality and fewer hospital readmissions. Participants will participate in the integrated SUD/ID care team intervention (SIRI Team). Researchers will compare this intervention to treatment as usual (TUA) to see if there are any differences in health outcomes.
Read the detailed description
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. The SIRI Team intervention will be grounded in a harm reduction approach. The intervention duration is approximately 4 months. Participants will complete follow-up visits at 4-, 8-, and 12-months post-randomization.
- Conditions
- Injection Site Infection, Substance Use Disorders
- Being tested
- SIRI Team, Treatment as Usual
- Keywords
- substance use disorders, severe injection-related infections, randomized controlled trial, hospital-based care, harm reduction
- Medical subject headings
- Substance-Related Disorders, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRI TeamBehavioural
Participants randomized to the intervention will receive integrated ID and SUD care (SIRI Team) both during the hospitalization and after hospital discharge for 4 months post-randomization. The intervention is based upon six general principles for treating PWID with infectious complications and is informed by harm reduction.
- Medications for SUD as integral to management of infectious complications
- Integration of ID and SUD care
- Longitudinal care with familiar providers
- Multidisciplinary care and care coordination
- Tailored antibiotic options and care settings
- Harm reduction
Treatment as UsualBehavioural
Participants assigned to the TAU group will receive the standard treatment for their severe injection-related infection and substance use disorder at each hospital. While TAU may differ between sites, it is typically comprised of a patient being cared for primarily by a hospital medicine physician (hospitalist) with consultation by infectious diseases (ID) and either psychiatry or addiction medicine physician. If the ID or addiction teams believe post-hospitalization follow up is indicated, each service will follow local protocols for arranging post-discharge continuation of care.
| Study group | Role | What they receive |
|---|---|---|
| SIRI Team | Experimental | 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. Receives: Behavioral: SIRI Team |
| Treatment as Usual | Active comparator | Treatment as Usual (TAU) will consist of the current healthcare landscape at each participating hospital site. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and Hospital Readmissions
Binary: A participant is alive with no hospital readmission 4 months post-randomization vs. a participant has died or been readmitted to the hospital within 4 months post-randomization
Measured: 4 months post-randomization
Secondary outcomes (9)
Initiation of treatment before hospital discharge
Binary: If patient initiated any of the treatments listed in protocol vs. if they did not engage
Measured: Course of hospital visit (expected to be within 1 month of randomization)
Receipt of post-discharge treatment
Binary: If patient initiated any of the treatments listed in protocol vs. if they did not engage
Measured: This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
Completion of planned antibiotic course for the index infection
Binary: If patient completed planned antibiotic course for the index infection vs. if they did not complete antibiotic course
Measured: Course of antibiotic treatment (Length varies by severity of infection); Assessed at the 4 month follow-up time
Patient-directed discharge from index hospitalization
Binary: Patient discharges themselves from the hospital prior to the attending physician's orders to discharge vs. does not discharge themselves
Measured: Course of hospital visit (expected to be within 1 month of randomization)
Post-discharge hospital visits
Count: # of post-discharge hospital visits using repeated measures across all 3 follow-up visits
Measured: This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
New or recurrent acute bacterial or fungal infection post-index hospitalization
Binary: Participant has a recurrent or persistent acute bacterial or fungal infection during the period of assessment vs. does not have a recurrent or persistent acute bacterial or fungal infection
Measured: This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
Substance use severity
Continuous: Assessed via Drug Abuse Screening Test (DAST-10) scale; Range of scores [0 - 10], higher scores indicate worse outcome
Measured: The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
Alcohol use severity
Continuous: Assessed via Alcohol Use Disorders Identification Test (AUDIT) scale; Range of scores [0 - 40], higher scores indicate worse outcome
Measured: The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
All-cause mortality
Binary: Mortality from all causes at any of the follow-up timepoints vs. alive at all timepoints
Measured: At each of the follow-up times (4, 8 and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start5 Jan 2024
- Primary completion3 Apr 2027 (estimated)
- Study completion3 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injection Site InfectionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will recruit patients at bedside in the hospital setting at approximately six hospitals and randomly assign approximately 480 inpatients in 1:1 ratio to the SIRI Team vs. TAU. Randomization will be stratified by 1) hospital site, 2) primary drug (opioid versus non-opioid), and 3) admission to intensive care unit (ICU) as part of the index hospitalization (ICU versus non-ICU) as a proxy for severity of infection.
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, Emory University, National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Responsible party
- Principal investigator, Lisa Metsch, Columbia University
- Investigators
- Lisa R Metsch, PhD, Principal investigator, Columbia UniversityDavid P Serota, MD, MSc, Principal investigator, University of MiamiDaniel J Feaster, PhD, Principal investigator, University of MiamiCarlos del Rio, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688423
- Sponsor's protocol ID
- 20221134
- Other IDs
- UG1DA013720
- Acronym
- CTN0121
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2022
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information about the study and the de-identified study data will be available at https://datashare.nida.nih.gov/ within 18 months of the date the data are locked, as per the procedures of the National Drug Abuse Treatment Clinical Trials Network.
Publications
Serota DP, Feaster DJ, Bartholomew TS, Kapadia SN, Gooden LK, Murphy SM, Malik S, Chueng TA, Hernandez S, Rodriguez AE, Alonso E, Horigian VE, Walker R, Matheson T, Moran LM, Nelson CM, Parish C, Tookes HE, Rio CD, Metsch LR. Integrated infectious disease and substance use disorder treatment for severe injection-related infections: protocol for the randomized controlled HI-SIRI trial. Addict Sci Clin Pract. 2026 Feb 21;21(1):28. doi: 10.1186/s13722-026-00654-6.
PubMed 41723493
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients
- ClinicalTrials.gov ID
- NCT05688423
- Acronym / sponsor ID
- CTN0121 / 20221134
- Conditions
- Injection Site Infection, Substance Use Disorders
- Keywords
- substance use disorders, severe injection-related infections, randomized controlled trial, hospital-based care, harm reduction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Miami, Emory University, National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 3 Apr 2027 (estimated)
- Study completion
- 3 Apr 2027 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test the effectiveness of an integrated infectious disease/substance use disorder (SUD) clinical team intervention approach in patients hospitalized with severe injection-related infections (SIRI) who use drugs. The main question this study aims to answer is whether this intervention approach will be associated with lower mortality and fewer hospital readmissions. Participants will participate in the integrated SUD/ID care team intervention (SIRI Team). Researchers will compare this intervention to treatment as usual (TUA) to see if there are any differences in health outcomes.
Detailed description
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. The SIRI Team intervention will be grounded in a harm reduction approach. The intervention duration is approximately 4 months. Participants will complete follow-up visits at 4-, 8-, and 12-months post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will recruit patients at bedside in the hospital setting at approximately six hospitals and randomly assign approximately 480 inpatients in 1:1 ratio to the SIRI Team vs. TAU. Randomization will be stratified by 1) hospital site, 2) primary drug (opioid versus non-opioid), and 3) admission to intensive care unit (ICU) as part of the index hospitalization (ICU versus non-ICU) as a proxy for severity of infection.
| Arm | Type | Receives |
|---|---|---|
| SIRI Team | Experimental | Behavioral: SIRI TeamThe 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. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualTreatment as Usual (TAU) will consist of the current healthcare landscape at each participating hospital site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIRI TeamParticipants randomized to the intervention will receive integrated ID and SUD care (SIRI Team) both during the hospitalization and after hospital discharge for 4 months post-randomization. The intervention is based upon six general principles for treating PWID with infectious complications and is informed by harm reduction. 1. Medications for SUD as integral to management of infectious complications 2. Integration of ID and SUD care 3. Longitudinal care with familiar providers 4. Multidisciplinary care and care coordination 5. Tailored antibiotic options and care settings 6. Harm reduction | Behavioural | SIRI Team |
| Treatment as UsualParticipants assigned to the TAU group will receive the standard treatment for their severe injection-related infection and substance use disorder at each hospital. While TAU may differ between sites, it is typically comprised of a patient being cared for primarily by a hospital medicine physician (hospitalist) with consultation by infectious diseases (ID) and either psychiatry or addiction medicine physician. If the ID or addiction teams believe post-hospitalization follow up is indicated, each service will follow local protocols for arranging post-discharge continuation of care. | Behavioural | Treatment as Usual |
Primary outcome
Mortality and Hospital Readmissions
Time frame: 4 months post-randomization
Binary: A participant is alive with no hospital readmission 4 months post-randomization vs. a participant has died or been readmitted to the hospital within 4 months post-randomization
9 secondary outcomes
Initiation of treatment before hospital discharge
Time frame: Course of hospital visit (expected to be within 1 month of randomization)
Receipt of post-discharge treatment
Time frame: This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
Completion of planned antibiotic course for the index infection
Time frame: Course of antibiotic treatment (Length varies by severity of infection); Assessed at the 4 month follow-up time
Patient-directed discharge from index hospitalization
Time frame: Course of hospital visit (expected to be within 1 month of randomization)
Post-discharge hospital visits
Time frame: This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
New or recurrent acute bacterial or fungal infection post-index hospitalization
Time frame: This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
Substance use severity
Time frame: The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
Alcohol use severity
Time frame: The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.
All-cause mortality
Time frame: At each of the follow-up times (4, 8 and 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Derived from this study: PubMed 41723493Serota DP, Feaster DJ, Bartholomew TS, Kapadia SN, Gooden LK, Murphy SM, Malik S, Chueng TA, Hernandez S, Rodriguez AE, Alonso E, Horigian VE, Walker R, Matheson T, Moran LM, Nelson CM, Parish C, Tookes HE, Rio CD, Metsch LR. Integrated infectious disease and substance use disorder treatment for severe injection-related infections: protocol for the randomized controlled HI-SIRI trial. Addict Sci Clin Pract. 2026 Feb 21;21(1):28. doi: 10.1186/s13722-026-00654-6.
- Individual participant dataSharing planned: Yes. Information about the study and the de-identified study data will be available at https://datashare.nida.nih.gov/ within 18 months of the date the data are locked, as per the procedures of the National Drug Abuse Treatment Clinical Trials Network.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIRI Team and Treatment as Usual in people with Injection Site Infection and Substance Use Disorders, run by Columbia University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality and Hospital Readmissions (time frame: 4 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05688423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.