Antimicrobial Catheter Lock Solution for the Treatment of Central Line Associated Bloodstream Infection (CLABSI)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Adverse Event Rate [ Time Frame: 7 days ] [ Designated as safety issue: No ]Adverse events include symptoms of discomfort and pain associated with antimicrobial lock therapy (ALT) as well as mechanical complications. Evaluation of symptoms of discomfort related to the ALT including pain, feelings of discomfort, irritation, headache, facial redness or flushing, feeling of drowsiness, nausea, alcohol taste, dyspnea, arrhythmias. Participants given a 0 to 10 numeric discomfort scale. Toxicity due to persistent bacteremia monitored at 7 days.
- Resolution Efficacy of CLABSI [ Time Frame: 1 month after treatment ] [ Designated as safety issue: No ]Clinical assessment pertaining to central line associated bloodstream infection (CLABSI) performed within one month from end of treatment with lock therapy. Following criteria represent infectious failure to respond: Persistent signs and symptoms associated with CLABSI (fever) after 72 hours of initiation of active systemic antimicrobial therapy. Persistent bacteremia. Relapse of bacteremia during follow-up. Development of related deep seated infections during follow-up. Infection related death during acute illness, relapse or development of related deep seated complications.
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Antimicrobial Lock Solution
Participants receive the HEAL antimicrobial solution for 2 hours once daily for a minimum of 5 consecutive days. Participants also receive the lock therapy once weekly for two additional weeks. Principle ingredients include minocycline, calcium disodium ethylenediaminetetraacetate (CaEDTA) and ethanol.
Drug: Antimicrobial Solution
Antimicrobial solution, consisting of minocycline in combination with a chelator (EDTA) in 25% ethanol solution (HEAL solution), instilled in central venous catheter (CVC) catheter for 2 hours once daily for a minimum of 5 consecutive days. Lock therapy also received once weekly for two additional weeks.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539343
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Fisch, MD, MPH||M.D. Anderson Cancer Center|