Catheter-Associated InfectionsPhase 1/2NCT02577718
Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution
A Phase 1/2 study testing Nitroglycerin-citrate-ethanol (NiCE) in people with Catheter-Associated Infections and Catheter-Related Infections, run by Novel Anti-Infective Technologies, LLC at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Associated Infections, Catheter-Related Infections
- What is being tested?
- Nitroglycerin-citrate-ethanol (NiCE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Oct 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Nitroglycerin-citrate-ethanol (NiCE)
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroglycerin-citrate-ethanol (NiCE)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Nitroglycerin-Citrate-Ethanol (NiCE) | Experimental | Antimicrobial Nitroglycerin-Citrate-Ethanol catheter lock solution was administered for 2 hours then flushed Receives: Drug: Nitroglycerin-citrate-ethanol (NiCE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization until date of first Drug-Related Hypotension within 10 minutes of each flush, assessed up to 60 days
Secondary outcomes (1)
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
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion22 Jun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter-Associated InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novel Anti-Infective Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577718
- Sponsor's protocol ID
- NiCE
- Status last verified
- Oct 2017
- First submitted
- 13 Oct 2015
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 28416559
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02577718
- Acronym / sponsor ID
- NiCE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novel Anti-Infective Technologies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Nov 2015
- Primary completion
- 22 Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitroglycerin-Citrate-Ethanol (NiCE) | Experimental | Drug: Nitroglycerin-citrate-ethanol (NiCE)Antimicrobial Nitroglycerin-Citrate-Ethanol catheter lock solution was administered for 2 hours then flushed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Nitroglycerin-Citrate-Ethanol (NiCE) |
Primary outcome
Number of Participants With Drug-Related Hypotension
Time frame: From date of randomization until date of first Drug-Related Hypotension within 10 minutes of each flush, assessed up to 60 days
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.
1 secondary outcome
Incidence of Catheter-Associated Infections
Time frame: 60 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28416559Chaftari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitroglycerin-citrate-ethanol (NiCE) in people with Catheter-Associated Infections and Catheter-Related Infections, run by Novel Anti-Infective Technologies, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Drug-Related Hypotension (time frame: From date of randomization until date of first Drug-Related Hypotension within 10 minutes of each flush, assessed up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02577718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.