CompletedNot Applicable

Clinical Study Evaluating the Efficacy and Safety of Colchicine in Adult Patients With Sepsis

Egypt46 participantsStarted 2023-11-01

Plain-language summary

Inflammatory markers are found to be an important contributor in sepsis. We evaluate the effect of colchicine on inflammatory processes and its possible protective effect against oxidative stress and organ dysfunction in adult patients suffering from sepsis.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Inclusion criteria: * Adult age ≥18 years old. * Both male and female sex. * Patients diagnosed with sepsis regardless its etiology according to the definitions of 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 * Pregnancy and breast-feeding women. * History of allergy or intolerance to Colchicine. * Patient with malignancies. * Uncontrolled hemorrhage. * Burn. * Patients on immunosuppressant or biological therapies. * Concomitant use of P-glycoprotein (P-gp) inhibitor such as: Verapamil, and Amiodarone or strong CYP3A4 inhibitor such as: Clarithromycin, Ritonavir and Ketoconazole.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change in the measured biological marker Serum Tumor necrosis factor-alpha (TNF-α) .

Timeframe: 10 Months

change in the measured biological marker Serum Malondialdehyde (MDA).

Timeframe: 10 Months

Trial details

NCT IDNCT07074990

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-30

View on ClinicalTrials.gov More Sepsis at Intensive Care Unit trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.