Antimicrobial Catheter Lock Solution for the Treatment of Central Line Associated Bloodstream Infection (CLABSI)

Infection Clinical Trial

Official title: Phase II Pilot Study to Estimate the Adverse Events Associated With the Lock Solution When Used to Salvage Central Venous Catheter (CVC) in the Setting of a Central Line Associated Bloodstream Infection (CLABSI)

Status Completed

Clinical Trial Summary

A CVC is a sterile flexible tube that allows a drug to flow from a bottle or bag directly into a patient's bloodstream. CVCs may cause infections when bacteria gets into the catheter and enters the bloodstream. They also have a risk of becoming clogged. When this occurs, the CVC usually needs to be replaced.

The goal of this clinical research study is to learn if an antimicrobial catheter lock solution can make it possible for the CVC to stay in place while treating an infection with antibiotics. The safety of the solution will also be tested.

Your outcome will be compared to the outcome of patients who had the same type of infection but had their CVC removed.

The antimicrobial catheter lock solution is made up of 3 chemicals:

Minocycline and ethanol are designed to disinfect the CVC. Disodium ethylenediaminetetraacetate is designed to prevent the CVC from clogging.

Clinical Trial Description

Study Drug Administration (Lock Solution):

If you are found to be eligible to take part in this study, the infection will be treated with antibiotics according to the standard of care. You will also receive the antimicrobial catheter lock solution through the CVC 2 hours per day for at least 5 days within the first week. In addition, you will receive the lock therapy for 2 additional days that could either be given on the following next 2 days or within the next 2 weeks. After locking the catheter for 2 hours, the HEAL lock will be cleared out, and the catheter will be flushed with normal saline and then locked with heparin or normal saline until the next time it needs to be used.

Study Visits:

On the first day after you receive the antimicrobial catheter lock solution, you will be checked for side effects such as pain, burning, discomfort, drowsiness, headache, facial redness, shortness of breath, and/or irregular heartbeat . After the last dose of receiving the catheter lock solution, you will be asked if you have experienced any side effects after receiving the catheter lock solution.

One (1) time each day while you are in the hospital, you will be checked for signs of infection and your vital signs (heart rate, breathing rate, blood pressure, and temperature) will be measured.

Every 2 days, blood (about 2 tablespoons) will be drawn to check for infection. This will continue until the blood draws no longer show signs of infection.

Every week, blood (about one teaspoon) will be drawn to check that your liver is function well.

Length of Study Participation:

You may receive the antimicrobial catheter lock solution for up to 7 days (over the course of 3 weeks). You will no longer be able to receive it if intolerable side effects occur or the infection does not go away after 7 days.

End of Treatment Visit:

• You will need to return to MD Anderson for your end of treatment visit within 7 days (+/- 3 days) after your last dose of study drug.

• At this visit, you will be asked about any symptoms or illnesses that you may have had since your last visit. You will be checked for signs of infection and your vital signs will be measured.

• Blood (about 2 tablespoons) will be drawn to check for infection. You will be asked about any antimicrobial drugs or therapies that you may be taking until the end of your treatment.

Follow-Up Visit:

You will have a follow-up visit about 1 month after receiving the last dose of antimicrobial catheter lock solution. At this visit, you will be checked for signs of infection and your vital signs will be measured. If the doctor thinks it is needed, blood (about 2 tablespoons) will be drawn to check for infection. You will be asked about any antimicrobial drugs that you may be taking until the end of your treatment.

This is an investigational study. The study lock solution is made up of minocycline, disodium ethylenediaminetetraacetate, and ethanol. Each of these are commercially available and FDA approved for other uses:

• Minocycline - for the treatment of cellulitis, acne, respiratory and urinary tract infections, gonococcal, chlamydial or ureaplasma urealyticum infections, cutaneous nocardiosis, and syphilis.

• Disodium ethylenediaminetetraacetate - for the treatment of lead poisoning

• Ethanol - for cleaning your hands

It is investigational to give minocycline, disodium ethylenediaminetetraacetate, and ethanol in combination as an antimicrobial lock solution.

Up to 30 patients will take part in this study. All will be enrolled at MD Anderson. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection

• NCT number: NCT01539343
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Completion date: April 2016