Vascepa for Community-Acquired Pneumonia

(TIN-CAP Trial)

Overseen By Poppy MacPhee, BScN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ottawa Heart Institute Research Corporation

Must not be taking: Prednisone, Methotrexate

Disqualifiers: Cancer, Inflammatory conditions, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

168 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. However, if you are on systemic anti-inflammatory therapy (like prednisone or methotrexate), you may not be eligible to participate.

How is the drug Icosapent Ethyl unique in treating community-acquired pneumonia?

Icosapent Ethyl, known for its use in reducing cardiovascular risk, is unique for community-acquired pneumonia as it may offer anti-inflammatory benefits, unlike standard treatments that primarily focus on antibiotics. This could provide a novel approach by potentially reducing inflammation in the lungs. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this clinical trial is to learn if icosapent ethyl (Vascepa) works to lessen the amount of inflammation in adults diagnosed with Community-Acquired Pneumonia (CAP). The main question it aims to answer is: What is the effect of taking Vascepa on inflammation in the arteries in patients with CAP? Researchers will compare the drug Vascepa to a placebo (a look-alike submstance that contains no drug) to see if Vascepa works to reduce inflammation in patients with CAP. Participants wil: * take Vacscepa or a placebo twice a day for 6 months * Visit the clinic 3 times (baseline, 30 days, and 6 months) for checkups and tests

Eligibility Criteria

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

I am over 18 years old.

I was hospitalized for pneumonia, confirmed by chest imaging and symptoms like fever and cough.

Patients who have given informed consent

Exclusion Criteria

Patients with dye allergy will not undergo CTA but will have PET/CT

Pregnant patients (all women of childbearing potential will have a negative BHCG test)

I have an active inflammatory condition or am on systemic anti-inflammatory therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take Vascepa or a placebo twice a day for 6 months

6 months

3 visits (in-person at baseline, 30 days, and 6 months)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Icosapent Ethyl
• Placebo

Trial Overview The trial is testing Icosapent Ethyl (Vascepa), comparing it to a placebo to see if it can reduce arterial inflammation in CAP patients. Participants will take either Vascepa or the placebo twice daily for six months and attend three clinic visits for evaluation.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Participants randomized to this arm will receive Vascepa for 6 months.

Group II: Placebo Placebo Group 1 Intervention

Participants randomized to this arm will receive placebo for 6 months.

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

References

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

Inhaled corticosteroids and systemic inflammatory response in community-acquired pneumonia: a prospective clinical study. [2022]

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

Effects of inhaled corticosteroids on pneumonia severity and antimicrobial resistance. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Current management of patients hospitalized with community-acquired pneumonia across Europe: outcomes from REACH. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The effect of inhaled corticosteroids in the outcomes of community-acquired pneumonia: ICCAP study (TURKCAP Database). [2021]

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

Advances in the prevention, management, and treatment of community-acquired pneumonia. [2018]