Sepsis at Intensive Care UnitNCT07074990
Clinical Study Evaluating the Efficacy and Safety of Colchicine in Adult Patients With Sepsis
A study testing conventional sepsis therapy alone and colchicine 500 mcg oral twice daily plus conventional sepsis therapy. in people with Sepsis at Intensive Care Unit, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis at Intensive Care Unit
- What is being tested?
- conventional sepsis therapy alone and colchicine 500 mcg oral twice daily plus conventional sepsis therapy.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 sex.
- Patients diagnosed with sepsis regardless its etiology according to the definitions of 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
- Pregnancy and breast-feeding women.
- History of allergy or intolerance to Colchicine.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating the Efficacy and Safety of Colchicine in Adult Patients With Sepsis.
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.
Read the 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.
- Conditions
- Sepsis at Intensive Care Unit
- Being tested
- conventional sepsis therapy alone, colchicine 500 mcg oral twice daily plus conventional sepsis therapy.
- Keywords
- Sepsis, Inflammation, Colchicine, Serum Tumor necrosis factor-alpha (TNF-α),Serum Malondialdehyde (MDA),Sequential Organ Failure Assessment (SOFA) score
- Medical subject headings
- Sepsis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional sepsis therapy aloneDrug
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.
colchicine 500 mcg oral twice daily plus conventional sepsis therapy.Drug
colchicine 500 mcg oral twice daily plus conventional sepsis therapy for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control group) | Placebo comparator | Not described Receives: Drug: conventional sepsis therapy alone |
| Group 2 (Colchicine group) | Active comparator | Not described Receives: Drug: colchicine 500 mcg oral twice daily plus conventional sepsis therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 Months
change in the measured biological marker Serum Malondialdehyde (MDA).
decrease in Serum Malondialdehyde (MDA) level means improvement from sepsis and better outcome.
Measured: 10 Months
Secondary outcomes (1)
change in Sequential Organ Failure Assessment (SOFA) score
decrease in Sequential Organ Failure Assessment (SOFA) score means improvement of organ dysfunction and improvement in sepsis ( better outcome)
Measured: 10 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Nov 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis at Intensive Care UnitStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, and controlled parallel design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Hamza Ismail Elmohr, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074990
- Sponsor's protocol ID
- colchicine in sepsis
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: scientific paper
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy and Safety of Colchicine in Adult Patients With Sepsis.
- ClinicalTrials.gov ID
- NCT07074990
- Acronym / sponsor ID
- colchicine in 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 20 Jul 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, and controlled parallel design
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (11 listed)
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 |
|---|---|---|
| conventional sepsis therapy alonefluid 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. | Drug | Group 1 (Control group) |
| colchicine 500 mcg oral twice daily plus conventional sepsis therapy.colchicine 500 mcg oral twice daily plus conventional sepsis therapy for 5 days. | Drug | Group 2 (Colchicine group) |
Primary outcome
change in the measured biological marker Serum Tumor necrosis factor-alpha (TNF-α) .
Time frame: 10 Months
decrease in (TNF-α) level means improvement from sepsis and better outcome
change in the measured biological marker Serum Malondialdehyde (MDA).
Time frame: 10 Months
decrease in Serum Malondialdehyde (MDA) level means improvement from sepsis and better outcome.
1 secondary outcome
change in Sequential Organ Failure Assessment (SOFA) score
Time frame: 10 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Yes. scientific paper
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional sepsis therapy alone and colchicine 500 mcg oral twice daily plus conventional sepsis therapy. in people with Sepsis at Intensive Care Unit, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 marker Serum Tumor necrosis factor-alpha (TNF-α) . (time frame: 10 Months). The study lists 2 primary outcomes in all. 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 23 Jul 2025.