Targeting Vascular INflammation in Patients With Community-Acquired Pneumonia

ConditionsInflammation Community Acquired Pneumonia (CAP)Inflammation Plaque, Atherosclerotic

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorOttawa Heart Institute Research Corporation

About 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 does not accept healthy volunteers

Qualifiers

Hospitalization with CAP (defined as pulmonary infiltration using chest imaging, in addition to other clinical symptoms including fever, cough, and sputum)

age > 18 years;

given informed consent.

Disqualifiers

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).

active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));

pregnancy (all women of child bearing potential will have a negative BHCG test;

breastfeeding;

Trial design

Design model

Parallel

Treatments tested in this trial

Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]
Drug
Participants randomized to the treatment arm will receive Vascepa 1000mg twice a day for 6 months.
Placebo
Drug
Placebo twice daily

Treatment groups

168 Participants

are divided into 2 treatment groups

Group A: TreatmentExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

The change over 6 months in the FDG uptake TBR as a marker of arterial plaque inflammation between the icosapent ethyl and placebo groups

Time frame

6 months

Secondary outcomes

The change in inflammation, measured on FDG PET, in the pulmonary tissue.

The change in background-corrected measure of total metabolic activity (total pulmonary glycolytic activity) will be measured.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Heart Institute Research Corporation

Lead sponsor

Source ClinicalTrials.gov

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