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NCT Number: NCT07572552

Clinical Study Evaluating the Efficacy and Safety of Fenofibrates Versus Silymarin in Adult Patients With Sepsis

Sepsis is a life-threatening condition defined by organ dysfunction resulting from the body's dysregulated response to an infection (1). It begins with widespread inflammation and cellular damage, which quickly escalates into total circulatory failure and the breakdown of essential organ systems, including the lungs, kidneys, digestive tract, and brain.

This study aims at evaluating the safety and efficacy of fenofibrate versus silymarin for adult patients with sepsis.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult age ≥18 years old. Both male and female patients. Patients diagnosed with sepsis regardless of its etiology, according to the definitions of the Surviving Sepsis Campaign (SSC)

Exclusion criteria

  • Late septic shock at presentation with multiple organ failure. Serious gastrointestinal disease. Preexisting end-stage liver disease. Preexisting end-stage renal disease. Pregnant and breastfeeding women. History of allergy or intolerance to fenofibrate or silymarin. Patients with malignancies. Uncontrolled hemorrhage. Patients on immunosuppressant or biological therapies.

Treatment and study plan

fenofibrate

Drug

fenofibrate (145 mg) once daily plus conventional sepsis therapy for 7 days.

Silymarin

Drug

silymarin does ranged between (980 - 1120 mg) daily, in divided doses plus conventional sepsis therapy for 7 days.

Primary outcomes

  1. change in the measured biological markers (TNF-α, MDA, and IL-10)

    Time frame: after seven days

    change in the measured biological markers (TNF-α, MDA, and IL-10)

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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