TaurolidineNCT07366372
Efficacy of Taurolidine Containing Lock Solution for Prevention of Central Venous Catheter Infection in ICU Patients
A study testing Saline, Tigecycline and heparin and Taurolidine-citrate-heparin in people with Taurolidine and Lock Solution, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to assess effectiveness of a taurolidine based lock solution in preventing the infections of central venous catheter (CVC) in intensive care unit (ICU) cases. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Taurolidine, Lock Solution, Prevention
- What is being tested?
- Saline, Tigecycline and heparin and Taurolidine-citrate-heparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Nov 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 21 years.
- Both genders.
- Patients admitted to the intensive care unit (ICU) requiring central venous catheter insertion.
Who cannot join
- Cases with active infections, hemorrhage or bleeding disorders, infections within insertion place.
- History of allergy to taurolidine, tigecycline, heparin, and citrate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Taurolidine Containing Lock Solution for Prevention of Central Venous Catheter Infection in ICU Patients
This study aimed to assess effectiveness of a taurolidine based lock solution in preventing the infections of central venous catheter (CVC) in intensive care unit (ICU) cases.
Read the detailed description
The central venous catheter (CVC) is highly frequent in the intensive care unit (ICU), with an average use rate between 32% and 80% among adult ICU patients. The utilization of CVC in ICUs has escalated over the past decade, accompanied by a corresponding increase in problems related to their usage.
Taurolidine is a nontoxic substance having antibacterial impacts counter to mutually gram-positive and -negative bacteria, additionally to fungus. It decreases biofilm development and doesn't develop resistance to antibiotics, since it serves as an antiseptic rather than an antibiotic Consequently, it may function as a locking mechanism.
- Conditions
- Taurolidine, Lock Solution, Prevention, Central Venous Catheter Infection, Intensive Care Unit
- Being tested
- Saline, Tigecycline and heparin, Taurolidine-citrate-heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Central venous catheters (CVCs) were locked with 2ml saline as a control group.
Tigecycline and heparinDrug
Central venous catheters (CVCs) were locked with 2ml of a solution comprising tigecycline 5mg/ml and heparin 500 IU/ml.
Taurolidine-citrate-heparinDrug
Central venous catheters (CVCs) were locked with 2ml of a solution containing taurolidine-citrate-heparin (1.35% taurolidine, 4% citrate, and 500 IU/ml heparin).
| Study group | Role | What they receive |
|---|---|---|
| Group I | Placebo comparator | Central venous catheters (CVCs) were locked with 2ml saline as a control group. Receives: Drug: Saline |
| Group II | Experimental | Central venous catheters (CVCs) were locked with 2ml of a solution comprising tigecycline 5mg/ml and heparin 500 IU/ml. Receives: Drug: Tigecycline and heparin |
| Group III | Experimental | Central venous catheters (CVCs) were locked with 2ml of a solution containing taurolidine-citrate-heparin (1.35% taurolidine, 4% citrate, and 500 IU/ml heparin). Receives: Drug: Taurolidine-citrate-heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive bacterial growth
Positive bacterial growth of a swab was recorded.
Measured: 30 days after the procedure
Secondary outcomes (4)
Assessment of catheter-related bloodstream infection
Assessment of catheter-related bloodstream infection was recorded.
Measured: 30 days after the procedure
Assessment of central venous catheter infection
Assessment of central venous catheter (CVC) infection was recorded.
Measured: 30 days after the procedure
Lenght of intensive care unit stay
Lenght of intensive care unit (ICU) stay was recorded.
Measured: 30 days after the procedure
Incidence of mortality
Incidence of mortality was recorded.
Measured: 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 May 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TaurolidineStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Kelany Zakaria Ibrahim, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366372
- Sponsor's protocol ID
- 36264MD73/4/23
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Taurolidine Containing Lock Solution for Prevention of Central Venous Catheter Infection in ICU Patients
- ClinicalTrials.gov ID
- NCT07366372
- Acronym / sponsor ID
- 36264MD73/4/23
- Conditions
- Taurolidine, Lock Solution, Prevention, Central Venous Catheter Infection, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 26 Jan 2026 (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.
This study aimed to assess effectiveness of a taurolidine based lock solution in preventing the infections of central venous catheter (CVC) in intensive care unit (ICU) cases.
Detailed description
The central venous catheter (CVC) is highly frequent in the intensive care unit (ICU), with an average use rate between 32% and 80% among adult ICU patients. The utilization of CVC in ICUs has escalated over the past decade, accompanied by a corresponding increase in problems related to their usage.
Taurolidine is a nontoxic substance having antibacterial impacts counter to mutually gram-positive and -negative bacteria, additionally to fungus. It decreases biofilm development and doesn't develop resistance to antibiotics, since it serves as an antiseptic rather than an antibiotic Consequently, it may function as a locking mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Placebo comparator | Drug: SalineCentral venous catheters (CVCs) were locked with 2ml saline as a control group. |
| Group II | Experimental | Drug: Tigecycline and heparinCentral venous catheters (CVCs) were locked with 2ml of a solution comprising tigecycline 5mg/ml and heparin 500 IU/ml. |
| Group III | Experimental | Drug: Taurolidine-citrate-heparinCentral venous catheters (CVCs) were locked with 2ml of a solution containing taurolidine-citrate-heparin (1.35% taurolidine, 4% citrate, and 500 IU/ml heparin). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 21 years.
- Both genders.
- Patients admitted to the intensive care unit (ICU) requiring central venous catheter insertion.
Key exclusion criteria (2 listed)
- Cases with active infections, hemorrhage or bleeding disorders, infections within insertion place.
- History of allergy to taurolidine, tigecycline, heparin, and citrate.
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 |
|---|---|---|
| SalineCentral venous catheters (CVCs) were locked with 2ml saline as a control group. | Drug | Group I |
| Tigecycline and heparinCentral venous catheters (CVCs) were locked with 2ml of a solution comprising tigecycline 5mg/ml and heparin 500 IU/ml. | Drug | Group II |
| Taurolidine-citrate-heparinCentral venous catheters (CVCs) were locked with 2ml of a solution containing taurolidine-citrate-heparin (1.35% taurolidine, 4% citrate, and 500 IU/ml heparin). | Drug | Group III |
Primary outcome
Positive bacterial growth
Time frame: 30 days after the procedure
Positive bacterial growth of a swab was recorded.
4 secondary outcomes
Assessment of catheter-related bloodstream infection
Time frame: 30 days after the procedure
Assessment of central venous catheter infection
Time frame: 30 days after the procedure
Lenght of intensive care unit stay
Time frame: 30 days after the procedure
Incidence of mortality
Time frame: 30 days after the procedure
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 26 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Taurolidine
Not yet recruiting
Neonatal Catheter Lock for Infection Prevention
CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection
Recruiting
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
Children, Medical Device
Active, not recruitingObservational study
Use of a Taurolidine Containing Antimicrobial Wash to Reduce Prosthetic Device Infection After Trauma Surgery
Osteosynthesis, Infection Prevention
Not yet recruitingObservational study
Survey of Practices Regarding the Use of Taurolidine Lock Solutions in Patients With Insertion of a Peripherally Inserted Central Catheter (PICC) in a Vascular Access Unit
Taurolidine Lock Solution
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 Saline, Tigecycline and heparin and Taurolidine-citrate-heparin in people with Taurolidine and Lock Solution, 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 2 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 26 Jan 2026. 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?
Positive bacterial growth (time frame: 30 days after the procedure). 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 26 Jan 2026.