Catheter-related Bloodstream InfectionNCT06707480
Expanded Access Program for Patients at Risk for Catheter-related Infections Who Are Not Eligible for DefenCath® Clinical Trials
A study testing Taurolidine and Heparin in people with Catheter-related Bloodstream Infection, run by CorMedix Therapeutics.
Trial summary
The EAP for DefenCath is designed to provide access to a broader population of adult and pediatric patients using catheters for various serious medical conditions. A key aspect of this EAP is its focus on individuals who, due to their unique clinical circumstances, are either ineligible for participation in ongoing… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Catheter-related Bloodstream Infection
- What is being tested?
- Taurolidine and Heparin
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Adult Patients: Male or female patients ≥18 years of age at the time of eligibility assessment, who are able and willing to provide informed consent.
- If the patient is unable to provide consent due to health status or mental capacity, a legally authorized representative (LAR) must provide written informed consent. Should the patient regain capacity, they must reconsent using the same consent form.
- Pediatric Patients: Male or female patients under 18 years of age at the time of eligibility assessment, with informed consent provided by an LAR if the patient is too young to consent or assent; patients capable of understanding the program may provide assent or full consent as appropriate.
- Patients receiving treatment through a catheter for serious medical conditions, including but not limited to hematologic and oncologic disorders, tumor-lysis syndrome, HD, TPN, peritoneal dialysis, intractable peritonitis, sickle-cell anemia and others. The catheter must be a permanent line made of silicone or polyurethane, in place for at least 7 days prior to enrollment. The specific type of catheter, e.g., peritoneal, tunneled, port-a-caths (ports), or peripherally inserted central catheter (PICC), must be documented.
- Patients who are able and willing to be trained, or have a caregiver, parent, or guardian capable of being trained, on the proper instillation and aspiration of DefenCath.
- Patients who have a minimum of a 4-hour CLS dwelling time.
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- If female and of childbearing potential, the patient must have a negative pregnancy test at the screening visit (i.e., the subject is not pregnant); not be lactating; and use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or hormonal contraceptive (oral, implant, ring, patch) for the duration of the program. (NOTE: The subject must have used the chosen method of birth control for at least 1 month/cycle prior to enrollment into the EAP).
- Male patients who are sexually active with a female partner of childbearing potential must agree to use male condoms with spermicide, even if the male patient has undergone a successful vasectomy (males with vasectomy can use condoms without spermicide), from Day 1 until at least 30 days after the last DefenCath CLS installation.
- Patients who agree to adhere to all program procedures and follow-up requirements.
- Patients must have received approval from Supplier or its designee following the submission of the Treating Physician's request.
Who cannot join
- Patients with visible evidence of compromised skin integrity present at the catheter exit site or catheter exit site infection.
- Patients with a temporary, non-tunneled catheter.
- Patients who are eligible to participate in the ongoing clinical trials with DefenCath.
- Patients who are eligible to use DefenCath as per country approved label.
- Patients that have received thrombolytic treatment (e.g., tissue-type plasminogen activator [tPA]-Cathflo), not as a part of the institution's standard of care for patency management, in the current catheter within 30 days of enrolment into the EAP.
- Patients with a clinically significant medical condition that, in the opinion of the Treating Physician, pose a high risk of adverse outcomes or could compromise their safety during the EAP.
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- Patients using any type of antimicrobial-coated or heparin-coated catheter.
- Patients with documented chronic bleeding diathesis, active or recurrent bleeding within 1 month prior to randomization.
- Patients with a congenitally lethal condition, a life expectancy of less than 3 months as determined by the Treating Physician.
- Patients with documented history of an atrial thrombus or known hypercoagulable state.
- Patients with known allergies or absolute contraindications to citrate, taurolidine, or heparin or a history of heparin-induced thrombocytopenia.
- Patients, or their immediate family members, who are the Treating Physician, sub-investigator, research assistant, pharmacist, site coordinator, or any other personnel directly involved in the conduct of the access program at the program site.
About this study
Official title: Expanded Access Program To Provide Access To Defencath® For Adult And Pediatric Patients Using A Catheter To Prevent Central Line-Associated Bloodstream Infections (CLABSIs)
The EAP for DefenCath is designed to provide access to a broader population of adult and pediatric patients using catheters for various serious medical conditions. A key aspect of this EAP is its focus on individuals who, due to their unique clinical circumstances, are either ineligible for participation in ongoing clinical trials or do not meet the criteria outlined in the current approved FDA label for DefenCath.
- Conditions
- Catheter-related Bloodstream Infection
- Being tested
- Taurolidine and Heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taurolidine and HeparinDrug
Also called DefenCath®
Catheter Lock Solution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-related Bloodstream InfectionStudies of the same condition, open and under way.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- CorMedix Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707480
- Sponsor's protocol ID
- EAP-CLABSI
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program To Provide Access To Defencath® For Adult And Pediatric Patients Using A Catheter To Prevent Central Line-Associated Bloodstream Infections (CLABSIs)
- ClinicalTrials.gov ID
- NCT06707480
- Acronym / sponsor ID
- EAP-CLABSI
- Conditions
- Catheter-related Bloodstream Infection
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- CorMedix TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 27 Nov 2024 (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.
The EAP for DefenCath is designed to provide access to a broader population of adult and pediatric patients using catheters for various serious medical conditions. A key aspect of this EAP is its focus on individuals who, due to their unique clinical circumstances, are either ineligible for participation in ongoing clinical trials or do not meet the criteria outlined in the current approved FDA label for DefenCath.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Adult Patients: Male or female patients ≥18 years of age at the time of eligibility assessment, who are able and willing to provide informed consent.
- If the patient is unable to provide consent due to health status or mental capacity, a legally authorized representative (LAR) must provide written informed consent. Should the patient regain capacity, they must reconsent using the same consent form.
- Pediatric Patients: Male or female patients under 18 years of age at the time of eligibility assessment, with informed consent provided by an LAR if the patient is too young to consent or assent; patients capable of understanding the program may provide assent or full consent as appropriate.
- Patients receiving treatment through a catheter for serious medical conditions, including but not limited to hematologic and oncologic disorders, tumor-lysis syndrome, HD, TPN, peritoneal dialysis, intractable peritonitis, sickle-cell anemia and others. The catheter must be a permanent line made of silicone or polyurethane, in place for at least 7 days prior to enrollment. The specific type of catheter, e.g., peritoneal, tunneled, port-a-caths (ports), or peripherally inserted central catheter (PICC), must be documented.
- Patients who are able and willing to be trained, or have a caregiver, parent, or guardian capable of being trained, on the proper instillation and aspiration of DefenCath.
Key exclusion criteria (12 listed)
- Patients with visible evidence of compromised skin integrity present at the catheter exit site or catheter exit site infection.
- Patients with a temporary, non-tunneled catheter.
- Patients who are eligible to participate in the ongoing clinical trials with DefenCath.
- Patients who are eligible to use DefenCath as per country approved label.
- Patients that have received thrombolytic treatment (e.g., tissue-type plasminogen activator [tPA]-Cathflo), not as a part of the institution's standard of care for patency management, in the current catheter within 30 days of enrolment into the EAP.
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 |
|---|---|---|
| Taurolidine and HeparinAlso: DefenCath®Catheter Lock Solution | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Taurolidine and Heparin in people with Catheter-related Bloodstream Infection, run by CorMedix Therapeutics.
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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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.
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 1 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.