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

NCT01539343 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-04-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Antimicrobial Solution

Antimicrobial solution, consisting of minocycline in combination with 30mg/ml of 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.

Sponsors & Collaborators

  • Triax

    collaborator UNKNOWN

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Ann-Marie Chaftari, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01539343 on ClinicalTrials.gov