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

Not Applicable

Completed

• Conditions: Sepsis at Intensive Care Unit
• Interventions: Drug: conventional sepsis therapy alone; Drug: colchicine 500 mcg oral twice daily plus conventional sepsis therapy.

• Registration Number: NCT07074990
• Lead Sponsor: Tanta University

Brief 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.

Detailed Description

Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis and septic shock are major healthcare problems, impacting millions of people around the world each year and killing between one in three and one in six of those it affects. Early identification and appropriate management in the initial hours after the development of sepsis improve outcomes .

Large quantities of proinflammatory cytokines released in patients with sepsis may spill into the bloodstream, contributing to the progression of a local infection to sepsis. These include tumor necrosis factor alpha (TNF-α), interleukin-1 (IL-1) and, interleukin-6 (IL-6), all of them can cause fever, hypotension, leukocytosis, induction of other proinflammatory cytokines, and the simultaneous activation of coagulation and fibrinolysis.

Taken together of all the aspects of the pathogenesis of sepsis, treatment modalities with anti-inflammatory effects could be considered for the successful treatment of sepsis. The available treatment strategies for management of sepsis include the use of fluid resuscitation and Empiric antibiotic therapy .

However, the limited success of antimicrobial in reducing the high mortality associated with sepsis and septic shock, increasing antibiotic resistance and medicine-resistant hemodynamic changes and our improved understandings of the pathogenesis of sepsis have resulted in further research on new treatment modalities in addition to classical treatments .

In particular, the identification of endotoxin-induced TNF-α and IL-1 production during sepsis as a major mediator of host damage, which culminates in potentially irreversible multi-organ dysfunction and shock, has led to the experimental use of a variety of interventions .

In this condition, novel agents must be developed or old drugs could be re-purposed to provide greater therapeutic outcome with fewer side effects at a minimum cost. Considering these facts, compounds from natural products may be considered as a promising and fruitful strategy for the treatment of sepsis.

Colchicine is a tricyclic, lipid-soluble alkaloid extracted from the plant of the Lily family Colchicum autumnale. The therapeutic use of colchicine has been well documented in gout and familial Mediterranean fever. it has also been used in other diseases including Behcet's disease, pericarditis, coronary artery disease and other inflammatory and fibrotic conditions .

Hypothesis: In this context, the outcomes of the previous animal studies and pilot study can provide a proof of concept for the implication of colchicine in clinical settings in order to improve the outcome in patients with sepsis and its efficacy in management of sepsis may depend on its anti-inflammatory and antioxidant effects.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Control group)	conventional sepsis therapy alone	-
Group 2 (Colchicine group)	colchicine 500 mcg oral twice daily plus conventional sepsis therapy.	-

Primary Outcome Measures

Name	Time	Method
change in the measured biological marker Serum Tumor necrosis factor-alpha (TNF-α) .	10 Months	decrease in (TNF-α) level means improvement from sepsis and better outcome
change in the measured biological marker Serum Malondialdehyde (MDA).	10 Months	decrease in Serum Malondialdehyde (MDA) level means improvement from sepsis and better outcome.

Secondary Outcome Measures

Name	Time	Method
change in Sequential Organ Failure Assessment (SOFA) score	10 Months	decrease in Sequential Organ Failure Assessment (SOFA) score means improvement of organ dysfunction and improvement in sepsis ( better outcome)

Trial Locations

Locations (1)

Faculty of Pharmacy - Tanta University; 🇪🇬 Tanta, Egypt