Clinical trial · Interventional
Clinical Study Evaluating the Efficacy and Safety of Colchicine in Adult Patients With Sepsis
Clinical Study Evaluating the Efficacy and Safety of Colchicine in Adult Patients With Sepsis.
NCT07074990CI-TRIAL-00092520completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sepsis at Intensive Care Unit | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| colchicine 500 mcg oral twice daily plus conventional sepsis therapy. | Drug | — | UNRESOLVED |
| conventional sepsis therapy alone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Group 1 (Control group)
- interventionNames
- Drug: conventional sepsis therapy alone
- type
- ACTIVE_COMPARATOR
- label
- Group 2 (Colchicine group)
- interventionNames
- Drug: colchicine 500 mcg oral twice daily plus conventional sepsis therapy.
Primary outcomes (2)
- measure
- change in the measured biological marker Serum Tumor necrosis factor-alpha (TNF-α) .
- timeFrame
- 10 Months
- description
- decrease in (TNF-α) level means improvement from sepsis and better outcome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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.
References
Publications (0)
Data not yet available
No reference posted for this study.