Holistic Treatment for Injection-Related Infections

(IRIS Trial)

Recruiting at 1 trial location

Overseen By Alisha Atri

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6-12 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the IRIS Program treatment for injection-related infections?

The research on integrated outpatient treatment for opioid use disorder and injection-related infections shows that combining addiction treatment with antibiotic therapy can be effective. This approach includes addiction consultation, medication for addiction, and outpatient antibiotic treatment, which has been successfully implemented in a pilot study. ^{1 2 3 4 5}

How is the IRIS Program treatment different from other treatments for injection-related infections?

The IRIS Program is unique because it combines addiction treatment with nurse-administered intravenous antibiotics in a residential setting, potentially reducing hospital costs and improving management for people who inject drugs. ^{1 2 4 5 6}

What is the purpose of this trial?

People who inject drugs are at risk of injection-related infections, like abscesses or infective endocarditis. The Injection-Related InfectionS (IRIS) program hopes to improve treatment for participants by providing a low-barrier, one-stop shop model for people who inject drugs who experience injection-related infections to access more holistic and compassionate care. IRIS is a non-randomized clinical trial, meaning that it offers a specific program to eligible patients. This program offers care for substance use and infectious disease with additional peer support and systems navigation, if interested. The investigators anticipate enrolling 80 participants in the intervention and will follow participants throughout the infection treatment period (estimated 6-12 weeks). The investigators will collect information at the time of enrolment, at the 6-month mark, and monthly via electronic medical chart review. The investigators will use an interrupted time series analysis to evaluate the impact of the intervention on rates of treatment completion, emergency department visits, hospitalizations, and death, before versus after the intervention.

Eligibility Criteria

The IRIS program is for individuals in Hamilton, Ontario who use injection drugs and have an infection related to this, like abscesses or heart valve infections. Participants must be 16 or older and able to give informed consent.

Inclusion Criteria

Able to provide informed consent

I have or might have an infection from an injection, including skin, bone, heart infections, Hepatitis C, or HIV.

I am 16 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a low-barrier, one-stop shop model of care for injection-related infections, including diagnosis, treatment, substance use care, peer support, and care coordination

6-12 weeks

Monthly visits via electronic medical chart review

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at the 6-month mark

6 months

1 visit at 6 months

Treatment Details

Interventions

• IRIS Program

Trial Overview This trial tests a holistic care approach for people with drug-related infections. It provides substance use treatment, infectious disease care, peer support, and help navigating the system without randomizing participants.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

Participants in the IRIS program will be offered a one-stop, low-barrier combined care model to address their injection-related infections. Specific program components include: (1) Diagnosis and treatment of injection-related infections; (2) Substance use treatment (3) Peer support; and (4) Care coordination/systems navigation.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Keeping Six

Collaborator

Trials

1

Recruited

80+

YWCA Hamilton

Collaborator

Trials

1

Recruited

80+

HAMSMaRT

Collaborator

Trials

1

Recruited

80+

Findings from Research

A novel integrated care model for patients with opioid use disorder (OUD) and severe injection-related infections (SIRI) allows for the combination of addiction treatment and outpatient parenteral antimicrobial therapy (OPAT), which is typically not offered to these patients due to concerns about their drug use.

This pilot study highlights the potential for improved management of OUD and SIRI by providing buprenorphine induction during hospitalization and continuing care in an outpatient setting, suggesting a promising approach to address both addiction and infection treatment simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated outpatient treatment of opioid use disorder and injection-related infections: A description of a new care model. Fanucchi, LC., Walsh, SL., Thornton, AC., et al.[2020]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Hospitalisation with injection-related infections: Validation of diagnostic codes to monitor admission trends at a tertiary care hospital in Melbourne, Australia. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Acute injection-related infections requiring hospitalisation among people who inject drugs: Clinical features, microbiology and management. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Integrated outpatient treatment of opioid use disorder and injection-related infections: A description of a new care model. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Residential addiction treatment for injection drug users requiring intravenous antibiotics: a cost-reduction strategy. [2013]

5. England pubmed.ncbi.nlm.nih.gov

"I know my body better than anyone else": a qualitative study of perspectives of people with lived experience on antimicrobial treatment decisions for injection drug use-associated infections. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Injection drug users: hospital care and charges. [2022]