Expanded Access Program for Patients At Risk for Catheter-related Infections Who Are Not Eligible⦠(NCT06707480) | Clinical Trial Compass
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Expanded Access Program for Patients At Risk for Catheter-related Infections Who Are Not Eligible for DefenCathĀ® Clinical Trials
Plain-language 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 clinical trials or do not meet the criteria outlined in the current approved FDA label for DefenCath.
Who can participate
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Inclusion Criteria:
* Adult Patients: Male or female patients ā„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.
* If female andā¦