Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-25 @ 4:37 PM
Study NCT ID:
NCT02577718
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution
Sponsor:
Novel Anti-Infective Technologies, LLC
Organization:
Study Overview
Official Title:
Phase 1/2 Study to Evaluate the Safety and Effectiveness of Novel Non-Antibiotic, Non-Heparin Nitroglycerin Based Catheter Lock Solution Used for the Prevention of Intraluminal Central Venous Catheter (CVC) Infections in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this Phase I/II pilot study is to evaluate the safety and effectiveness of a non- antibiotic chelator based lock solution that contains nitroglycerin in combination with sodium citrate and ethanol (NiCE lock solution) for prevention of central line associated bloodstream infection (CLABSI).
* The primary objective of this study is to evaluate the safety and estimate the rate of adverse events associated with the NiCE lock solution.
* The second primary objective is to estimate the rate of CLABSI in patients receiving the NiCE lock solution.
* The primary objective of this study is to evaluate the safety and estimate the rate of adverse events associated with the NiCE lock solution.
* The second primary objective is to estimate the rate of CLABSI in patients receiving the NiCE lock solution.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: