NCT02577718

Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Novel Anti-Infective Technologies, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Catheter-Associated Infections
• Catheter-Related Infections

Interventions

Type	Name	Description
DRUG	Nitroglycerin-citrate-ethanol (NiCE)	Lock solution instilled in catheter lumens for 2 hours then flushed. Administration for up to 30 days, daily as in-patient or once weekly as out-patient

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-06-22
• Completion: 2016-10-01
• First posted: 2015-10-16
• Last updated: 2017-11-06
• Results posted: 2017-11-06

Locations

1 site across 1 country: United States