Vascepa for Community-Acquired Pneumonia
(TIN-CAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Vascepa (Icosapent Ethyl), a medication, can reduce inflammation in the arteries of adults with community-acquired pneumonia (a lung infection). Researchers aim to determine if Vascepa is more effective at reducing inflammation than a placebo, which contains no active ingredients. Participants will take either Vascepa or the placebo twice daily for six months and attend three clinic visits for checkups. This trial may suit adults hospitalized with community-acquired pneumonia who experience symptoms like fever and cough. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on systemic anti-inflammatory therapy (like prednisone or methotrexate), you may not be eligible to participate.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that icosapent ethyl, also known as Vascepa, is generally safe for people. Studies have found it to be well-tolerated, even for conditions like heart disease. For instance, one study found it reduced heart-related problems without major safety issues. Another study with COVID-19 pneumonia patients showed that icosapent ethyl was safely used as part of their treatment.
While these findings suggest the treatment is safe, participants should discuss any potential risks with their doctor.12345Why do researchers think this study treatment might be promising for pneumonia?
Unlike standard treatments for community-acquired pneumonia, which typically involve antibiotics and supportive care, Vascepa (Icosapent Ethyl) offers a novel approach by using a purified omega-3 fatty acid. Researchers are excited because it potentially reduces inflammation and improves immune response, offering a different mechanism of action compared to traditional antibiotics. This could be especially beneficial for patients who need alternative or additional support beyond what antibiotics can provide.
What evidence suggests that Vascepa might be an effective treatment for Community-Acquired Pneumonia?
Research has shown that icosapent ethyl, also known as Vascepa, can help reduce inflammation, which is important in conditions like community-acquired pneumonia (CAP). One study demonstrated that patients with inflammation-related conditions experienced a noticeable decrease in inflammation markers after taking Vascepa. Specifically, levels of markers like creatinine and CRP decreased, indicating improvement. Additionally, Vascepa has been shown to lower the risk of heart problems, suggesting wider anti-inflammatory benefits. In this trial, participants will receive either Vascepa or a placebo for 6 months to evaluate its potential to reduce inflammation in patients with CAP.12367
Are You a Good Fit for This Trial?
This trial is for adults with Community-Acquired Pneumonia (CAP) who are interested in testing a treatment aimed at reducing artery inflammation. Specific eligibility details aren't provided, but typically participants must meet certain health criteria and not have conditions that could interfere with the study or their safety.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take Vascepa or a placebo twice a day for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Icosapent Ethyl
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Heart Institute Research Corporation
Lead Sponsor