SepsisPhase 2NCT07572552
Clinical Study Evaluating the Efficacy and Safety of Fenofibrates Versus Silymarin in Adult Patients With Sepsis
A Phase 2 study testing Fenofibrate and Silymarin in people with Sepsis, run by Tanta University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Fenofibrate and Silymarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
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.
- Conditions
- Sepsis
- Being tested
- Fenofibrate, Silymarin
- Keywords
- Sepsis, fenofibrate, silymarin
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
fenofibrate (145 mg) once daily plus conventional sepsis therapy for 7 days.
SilymarinDrug
silymarin does ranged between (980 - 1120 mg) daily, in divided doses plus conventional sepsis therapy for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Fenofibrate group | Experimental | Not described Receives: Drug: Fenofibrate |
| Silymarin group | Experimental | Not described Receives: Drug: Silymarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the measured biological markers (TNF-α, MDA, and IL-10)
change in the measured biological markers (TNF-α, MDA, and IL-10)
Measured: after seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study startMay 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed El Attar, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572552
- Sponsor's protocol ID
- 36265MD41030/1/26
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy and Safety of Fenofibrates Versus Silymarin in Adult Patients With Sepsis
- ClinicalTrials.gov ID
- NCT07572552
- Acronym / sponsor ID
- 36265MD41030/1/26
- Conditions
- Sepsis
- Keywords
- Sepsis, fenofibrate, silymarin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Fenofibrate group | Experimental | Drug: Fenofibrate |
| Silymarin group | Experimental | Drug: Silymarin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenofibratefenofibrate (145 mg) once daily plus conventional sepsis therapy for 7 days. | Drug | Fenofibrate group |
| Silymarinsilymarin does ranged between (980 - 1120 mg) daily, in divided doses plus conventional sepsis therapy for 7 days. | Drug | Silymarin group |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
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Streptococcus Agalactiae Infection, Neonatal Sepsis
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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fenofibrate and Silymarin in people with Sepsis, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the measured biological markers (TNF-α, MDA, and IL-10) (time frame: after seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.