Clinical trial NCT06710080: Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia
Official title: Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia (TIN_CAP): a Multi-centre, Prospective, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Inflammation
Community Acquired Pneumonia (CAP)
Inflammation Plaque, Atherosclerotic
Keywords: Community-Acquired Infection
Plaque, atherosclerotic
Inflammation
Eicosapentaenoic Acid
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: TIN CAP is a multi centre, prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the use of icosapent ethyl (Vascepa) on vascular inflammation in patients with CAP using FDG-PET/CT imaging and measurement of circulating biomarkers. The current proposal uses a randomized design to:

1. measure the effect of icosapent ethyl vs. placebo on reducing arterial inflammation over a 6-month treatment period, with primary analysis at 6-months;
2. the correlation between imaging and blood biomarkers over time relative to the drug response.

Eligibility criteria: Inclusion Criteria:

Patients who have:

1. Hospitalization with CAP (defined as pulmonary infiltration using chest imaging, in addition to other clinical symptoms including fever, cough, and sputum)
2. age \> 18 years;
3. given informed consent.

Exclusion Criteria:

Patients who have:

1. history of cancer within the last 3 years (other than a successfully treated cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix).
2. active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));
3. pregnancy (all women of child bearing potential will have a negative BHCG test;
4. breastfeeding;
5. Women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception.
6. Allergies to icosapent ethyl
7. allergies to fish or shellfish
8. glomerular filtration rate (GFR) \<50 ml/min/1.72m2 (excluded from CTA portion)
9. unable to give informed consent;

Exclusion for CTA portion of the protocol:

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

Primary outcomes:
measure: The change over 6 months in the FDG uptake TBR as a marker of arterial plaque inflammation between the icosapent ethyl and placebo groups
timeFrame: 6 months
Secondary outcomes:
measure: The change in inflammation, measured on FDG PET, in the pulmonary tissue.
timeFrame: 6 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
References: