Holistic Treatment for Injection-Related Infections

(IRIS Trial)

Not yet recruiting at 1 trial location

Overseen By Alisha Atri

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: None specified

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

Compensation: Varies

Number of Visits: 1

Duration: 6-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for people who inject drugs and experience injection-related infections, such as abscesses or infective endocarditis. The IRIS Program provides a combined care model that includes treatment for infections and substance use, peer support, and assistance with navigating healthcare systems. It targets individuals in Hamilton, Ontario, who have used injection drugs in the past three months and are currently dealing with or suspect they have an injection-related infection. Participants receive holistic and compassionate care in a low-barrier, one-stop setting, facilitating treatment completion and reducing emergency visits and hospital stays. As an unphased trial, this study offers participants access to innovative care approaches that could significantly improve their health outcomes.

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 prior data suggests that the IRIS program is safe for participants?

Research has shown that combining care for infectious diseases with treatment for substance use can be safe and effective for people who inject drugs. One study found that these programs increased participants' use of healthcare services and completion of antibiotic treatments, leading to better health outcomes.

Another study demonstrated that integrated care can reduce hospital visits and improve adherence to treatment plans. This suggests that the IRIS Program, which offers a one-stop approach with peer support and care coordination, may be well-received and beneficial. Although specific safety data for the IRIS Program is not available, findings from similar programs suggest it should be a safe option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IRIS Program because it offers a comprehensive, one-stop approach for treating injection-related infections. Unlike conventional treatments that might focus solely on medication or wound care, the IRIS Program integrates diagnosis and treatment with substance use support, peer support, and care coordination. This holistic and low-barrier model aims to tackle the root causes of infections, making it easier for participants to access and benefit from multi-faceted care. By combining medical treatment with support systems, it has the potential to improve both health outcomes and quality of life for individuals.

What evidence suggests that the IRIS program is effective for injection-related infections?

Research has shown that the IRIS Program, which participants in this trial will receive, provides care for both infections and substance use, improving health for people who inject drugs. One study found that a team addressing both infectious diseases and substance use disorders led to better healthcare use, more patients starting medication for opioid addiction, and more people completing their antibiotics. Another source noted that care models like IRIS can reduce hospital stays and related costs for those with severe infections from injections. These findings suggest that the IRIS Program could effectively address both infections and substance use issues, potentially improving overall treatment success. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9830545/

Integrated Infectious Disease and Substance Use Disorder ... An integrated ID/SUD team was associated with improvements in healthcare utilization, MOUD initiation, and antibiotic completion for PWID with infections.

2. withpower.com withpower.com/trial/phase-infections-2024-0f877

Holistic Treatment for Injection-Related Infections (IRIS Trial) The IRIS medical study, being run by McMaster University, needs participants to evaluate whether IRIS Program will have tolerable side effects & efficacy ...

3. clinicaltrial.be clinicaltrial.be/en/details/418907?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

The Injection-Related InfectionS (IRIS) Program - Clinica... The investigators will use an interrupted time series analysis to evaluate the impact of the intervention on rates of treatment completion, ...

4. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-023-00363-4

Implementation of an integrated infectious disease and ... Hospitalizations for severe injection drug use-related infections (SIRIs) are characterized by high costs, frequent patient-directed discharge,

5. academic.oup.com academic.oup.com/ofid/article/9/2/ofab633/6499353

Patients With Serious Injection Drug Use–Related Infections ... For PWID with a PDD on oral antibiotics, 7.6% had documented nonadherence to antibiotics, 67% had documented adherence, and 23% were lost to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8801224/

Patients With Serious Injection Drug Use–Related ... Persons who inject drugs (PWID) are frequently admitted for serious injection-related infections (SIRIs). Outcomes and adherence to oral antibiotics for PWID ...

7. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-024-01129-0

Assessment of harm reduction receipt and infectious diseases ... Injection drug use (IDU) may lead to negative health outcomes and increased healthcare utilization. In US Veterans (USV) with opioid use ...

8. academic.oup.com academic.oup.com/ofid/article/12/5/ofaf257/8121584

Incidence, Patient-Directed Discharge, Readmission, and ... This study aimed to describe population-level trends in hospitalization for bacterial and fungal injecting-related infections and related outcomes among persons ...