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Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution

NCT02577718 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-11-06

Study results available
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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

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

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Novel Anti-Infective Technologies, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-06-22
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02577718 on ClinicalTrials.gov