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This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD for kidney failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DefenCath® | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (taurolidine and heparin) catheter lock solution | Drug | for central venous catheter instillation use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first clinical diagnosis of Catheter-related Bloodstream Infections (CRBSI) | To demonstrate the effectiveness of DefenCath as a catheter lock solution (CLS) for prevention of CRBSI in pediatric participants receiving chronic hemodialysis (HD) through a central venous catheter (CVC) for the treatment of kidney failure. | Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months) |
| Descriptive analysis characterizing the relative rates of deaths, AEs, and SAEs | To demonstrate safety of DefenCath as a CLS in pediatric participants receiving chronic HD through a CVC for the treatment of kidney failure | Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to catheter removal due to CRBSI | To evaluate the catheter removal due to CRBSI in pediatric participants who are receiving chronic HD through a CVC for kidney failure. | Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months) |
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Inclusion Criteria:
Combined (containing estrogen and progestogen) hormonal birth control (oral, intravaginal, injectable, or transdermal) associated with inhibition of ovulation initiated at least 30 days before dose administration.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liz Hurlburt | Contact | 9085179500 | lhurlburt@cormedix.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama/University of Alabama | Recruiting | Birmingham | Alabama | 35233 | United States |
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| Standard of Care | Drug | Site specific standard of care |
|
| Phoenix Children's Hospital | Recruiting | Phoenix | Arizona | 85016 | United States |
|
| Stanford | Recruiting | Palo Alto | California | 94304 | United States |
|
| Nemours Children's Hospital - DE | Recruiting | Wilmington | Delaware | 19803 | United States |
|
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| Cook Children's Health Care System | Recruiting | Fort Worth | Texas | 76104 | United States |
|
| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C012566 | taurolidine |
| D006493 | Heparin |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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