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

NCT07074990 | Completed DMC

• 1 other identifier: colchicine in sepsis
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis at Intensive Care Unit

Keywords

Sepsis, Inflammation, Colchicine, Serum Tumor necrosis factor-alpha (TNF-α),Serum Malondialdehyde (MDA),Sequential Organ Failure Assessment (SOFA) score

Outcome Measures

Primary Outcomes (2)

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

  decrease in (TNF-α) level means improvement from sepsis and better outcome

  10 Months

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

  decrease in Serum Malondialdehyde (MDA) level means improvement from sepsis and better outcome.

  10 Months

Secondary Outcomes (1)

• change in Sequential Organ Failure Assessment (SOFA) score

  10 Months

Study Arms (2)

Group 1 (Control group)

PLACEBO COMPARATOR

Drug: conventional sepsis therapy alone

Group 2 (Colchicine group)

ACTIVE COMPARATOR

Drug: colchicine 500 mcg oral twice daily plus conventional sepsis therapy.

Interventions

conventional sepsis therapy alone DRUG

fluid resuscitation a minimum of 30 mL/kg of intravenous (IV) crystalloid fluid administered during the initial 3 hours of resuscitation, along with empiric antibiotic therapy aimed at the suspected pathogens and infection sites, ideally starting within the first hour.

Group 1 (Control group)

colchicine 500 mcg oral twice daily plus conventional sepsis therapy. DRUG

colchicine 500 mcg oral twice daily plus conventional sepsis therapy for 5 days.

Group 2 (Colchicine group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult age ≥18 years old.
• Both male and female sex.
• Patients diagnosed with sepsis regardless its etiology according to the definitions of SSC .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Pharmacy - Tanta University

Tanta, Tanta, 31111, Egypt

Location

MeSH Terms

Conditions

Sepsis; Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: randomized, double-blind, and controlled parallel design

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: November 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)