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Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution

Primary Purpose

Catheter-Associated Infections, Catheter-Related Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nitroglycerin-citrate-ethanol (NiCE)
Sponsored by
Novel Anti-Infective Technologies, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter-Associated Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inpatients who have a long term central venous catheter (CVC)-and the CVC has been in place for at least 14 days and is expected to remain in place at least for 30 days after enrollment
  • The CVC consists of a 5.0 French size, dual-lumen, peripherally inserted central catheter
  • Patients who are willing and capable to provide Informed Consent
  • Patients who are willing and capable to follow the instructions required to complete the study
  • Females (of child bearing potential) and males (of child bearing potential) must be abstinent or agree to use birth control during the study.

Exclusion Criteria:

  • Patients who have an antimicrobial CVC.
  • Patients who have a short term CVC that have been placed in ICU (mainly rigid wall CVCs placed for acute care in ICU).
  • Patients who are hypotensive with a systolic blood pressure reading of <110 mmHg at any time over the 3 days prior to study entry
  • Patients who are not awake, not alert, or who cannot express pain or discomfort related to the catheter locks
  • Patients with an existing local or systemic infection as defined by evidence of fever (a body temperature > 38.0o C with two readings taken at least 10 minutes apart or one body temperature > 38.3o) and any of the following within 24 hours of enrollment: Pulse rate > 100 beats/min.; Respiratory rate > 20/min.; WBC count >12,000/mm3, <4,000/mm3 or differential count showing >10% band forms. Patient will still be eligible for the study if the participant's white blood cell count (WBC) is outside normal limits due to chemotherapy treatment or underlying conditions. Systolic blood pressure <90 mm Hg.
  • Signs and symptoms of localized catheter-related infection (tenderness and/or pain, erythema, swelling, purulent exudates within 2 cm of entry site)
  • Patients with an occluded (partially or totally) catheter defined as inability to either withdraw blood or instill 3cc of fluid without resistance through any catheter lumen
  • Patients with multiple co-existing central venous catheters at the time of enrollment will not be enrolled.
  • Patients in whom the lock solution application will interfere with routine treatment of the underlying disease
  • Patients with a known history of allergic reaction to ethanol, nitroglycerin, or citrate.
  • Female patients who are pregnant or breast feeding
  • Patients who are on disulfiram, metronidazole or are dependent on alcohol
  • Patients receiving phosphodiesterase type 5 (PDE-5) inhibitors (such as sildenafil, tadalafil, vardenafil).

Sites / Locations

  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nitroglycerin-Citrate-Ethanol (NiCE)

Arm Description

Antimicrobial Nitroglycerin-Citrate-Ethanol catheter lock solution was administered for 2 hours then flushed

Outcomes

Primary Outcome Measures

Number of Participants With Drug-Related Hypotension
Drug-related hypotension is defined as a significant drop in measured blood pressure (BP) that exceeds the normal BP variability of a patient by 30%, that is associated with clinical signs and symptoms (dizziness and syncope) and is unexplained by factors other than the lock solution (such as other antihypertensive drugs, sepsis, bleeding). BP variability will be based on the standard deviation (SD) of a patient's blood pressure measured in the 3 days preceding participation in this trial and will be calculated at the time of trial entry.

Secondary Outcome Measures

Incidence of Catheter-Associated Infections
Catheter-Associated Infections will be measured by microbiological culture defined as either Catheter-Related Bloodstream Infection (CRBSI) as defined by the Infectious Diseases Society of America (IDSA), particularly in neutropenic patients, or Central Line-Associated Bloodstream Infection (CLABSI) as defined by the Centers for Disease Control and Prevention (CDC), particularly in non-neutropenic patients

Full Information

First Posted
October 13, 2015
Last Updated
October 2, 2017
Sponsor
Novel Anti-Infective Technologies, LLC
Collaborators
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02577718
Brief Title
Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 22, 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novel Anti-Infective Technologies, LLC
Collaborators
M.D. Anderson Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Associated Infections, Catheter-Related Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nitroglycerin-Citrate-Ethanol (NiCE)
Arm Type
Experimental
Arm Description
Antimicrobial Nitroglycerin-Citrate-Ethanol catheter lock solution was administered for 2 hours then flushed
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin-citrate-ethanol (NiCE)
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With Drug-Related Hypotension
Description
Drug-related hypotension is defined as a significant drop in measured blood pressure (BP) that exceeds the normal BP variability of a patient by 30%, that is associated with clinical signs and symptoms (dizziness and syncope) and is unexplained by factors other than the lock solution (such as other antihypertensive drugs, sepsis, bleeding). BP variability will be based on the standard deviation (SD) of a patient's blood pressure measured in the 3 days preceding participation in this trial and will be calculated at the time of trial entry.
Time Frame
From date of randomization until date of first Drug-Related Hypotension within 10 minutes of each flush, assessed up to 60 days
Secondary Outcome Measure Information:
Title
Incidence of Catheter-Associated Infections
Description
Catheter-Associated Infections will be measured by microbiological culture defined as either Catheter-Related Bloodstream Infection (CRBSI) as defined by the Infectious Diseases Society of America (IDSA), particularly in neutropenic patients, or Central Line-Associated Bloodstream Infection (CLABSI) as defined by the Centers for Disease Control and Prevention (CDC), particularly in non-neutropenic patients
Time Frame
60 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inpatients who have a long term central venous catheter (CVC)-and the CVC has been in place for at least 14 days and is expected to remain in place at least for 30 days after enrollment The CVC consists of a 5.0 French size, dual-lumen, peripherally inserted central catheter Patients who are willing and capable to provide Informed Consent Patients who are willing and capable to follow the instructions required to complete the study Females (of child bearing potential) and males (of child bearing potential) must be abstinent or agree to use birth control during the study. Exclusion Criteria: Patients who have an antimicrobial CVC. Patients who have a short term CVC that have been placed in ICU (mainly rigid wall CVCs placed for acute care in ICU). Patients who are hypotensive with a systolic blood pressure reading of <110 mmHg at any time over the 3 days prior to study entry Patients who are not awake, not alert, or who cannot express pain or discomfort related to the catheter locks Patients with an existing local or systemic infection as defined by evidence of fever (a body temperature > 38.0o C with two readings taken at least 10 minutes apart or one body temperature > 38.3o) and any of the following within 24 hours of enrollment: Pulse rate > 100 beats/min.; Respiratory rate > 20/min.; WBC count >12,000/mm3, <4,000/mm3 or differential count showing >10% band forms. Patient will still be eligible for the study if the participant's white blood cell count (WBC) is outside normal limits due to chemotherapy treatment or underlying conditions. Systolic blood pressure <90 mm Hg. Signs and symptoms of localized catheter-related infection (tenderness and/or pain, erythema, swelling, purulent exudates within 2 cm of entry site) Patients with an occluded (partially or totally) catheter defined as inability to either withdraw blood or instill 3cc of fluid without resistance through any catheter lumen Patients with multiple co-existing central venous catheters at the time of enrollment will not be enrolled. Patients in whom the lock solution application will interfere with routine treatment of the underlying disease Patients with a known history of allergic reaction to ethanol, nitroglycerin, or citrate. Female patients who are pregnant or breast feeding Patients who are on disulfiram, metronidazole or are dependent on alcohol Patients receiving phosphodiesterase type 5 (PDE-5) inhibitors (such as sildenafil, tadalafil, vardenafil).
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28416559
Citation
Chaftari AM, Hachem R, Szvalb A, Taremi M, Granwehr B, Viola GM, Amin S, Assaf A, Numan Y, Shah P, Gasitashvili K, Natividad E, Jiang Y, Slack R, Reitzel R, Rosenblatt J, Mouhayar E, Raad I. A Novel Nonantibiotic Nitroglycerin-Based Catheter Lock Solution for Prevention of Intraluminal Central Venous Catheter Infections in Cancer Patients. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00091-17. doi: 10.1128/AAC.00091-17. Print 2017 Jul. Erratum In: Antimicrob Agents Chemother. 2017 Jul 25;61(8):
Results Reference
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Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution

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