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

NCT01539343 | Completed Phase 2

• 2 other identifiers: 2011-1019NCI-2012-00302
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Infection

Keywords

Infection; Catheter-related bloodstream infection; CRBSI; Antimicrobial Lock Therapy; ALT; Central Line Associated Bloodstream Infection; CLABSI; Central Venous Catheter; CVC; Quantitative blood cultures; QBC

Outcome Measures

Primary Outcomes (1)

• Adverse Event Rate

  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.

  7 days

Secondary Outcomes (1)

• Resolution Efficacy of CLABSI

  1 month after treatment

Study Arms (1)

Antimicrobial Lock Solution

EXPERIMENTAL

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

Interventions

Antimicrobial Solution DRUG

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.

Antimicrobial Lock Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older
• Patients with indwelling CVC that have been in place for at least 14 days with documented CLABSI as defined by CDC \[62\]. In neutropenic patients (defined as an absolute neutrophil count (ANC) \< 500 cells/mm3) with CLABSI, to confirm that CVC is the source of the bacteremia, we will use the definitions of catheter-related bloodstream infection (CRBSI) based on the mgmt guidelines of intravascular catheter related infections published by IDSA \[10\]. This includes the evidence that points to the CVC as the culprit: a) Paired quantitative blood cultures (QBC), whereby QBC are drawn through the CVC and peripheral vein and the blood cultures from the CVC reveal 3-fold greater number of colonies than the peripherally drawn QBC. b) Differential time to positivity, where blood cultures simultaneously drawn from the CVC and peripheral vein are positive for the same organism, and the catheter-drawn blood culture turns positive at least 2 hours earlier than the peripherally drawn blood culture.
• Female patients must be non-lactating and at no risk for pregnancy for one of the following reasons: a) Postmenopausal for at least one year b) Post-hysterectomy and/or post-bilateral ovariectomy and/or other surgical sterilization c) If of childbearing potential, having a negative urine or serum human chorionic gonadotropin (hCG) pregnancy test within 5 days prior to study enrollment and be using a highly effective method of birth control throughout the course of the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study.
• Patients with short term non-tunneled catheters will be enrolled only if CVC cannot be removed or exchanged (patient refuses to have CVC removed, CVC needed and no other vascular access available, patient is thrombocytopenic (platelet count below 20,000) that will prohibit inserting a new CVC at a different site).

You may not qualify if:

• Patients allergic to tetracycline antibiotics or calcium EDTA
• Patients on disulfiram or disulfiram like drugs
• Patients with severe sepsis, septic shock, hypotension or who are considered otherwise unstable
• Presence of prosthetic valve
• Presence of signs of metastatic deep-seated infection such as osteomyelitis or septic pulmonary infarcts or endocarditis (as evidenced by vegetations on an echocardiogram), or septic thrombosis
• Patients with tunnel or catheter exit site infection or infusion port pocket abscess as manifested by purulence at the exit site or inflammation with erythema or induration of \>1 cm in diameter.
• Patients with Candida line infection
• Patients who have been previously entered on the study

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Triax: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Raad I, Chaftari AM, Zakhour R, Jordan M, Al Hamal Z, Jiang Y, Yousif A, Garoge K, Mulanovich V, Viola GM, Kanj S, Pravinkumar E, Rosenblatt J, Hachem R. Successful Salvage of Central Venous Catheters in Patients with Catheter-Related or Central Line-Associated Bloodstream Infections by Using a Catheter Lock Solution Consisting of Minocycline, EDTA, and 25% Ethanol. Antimicrob Agents Chemother. 2016 May 23;60(6):3426-32. doi: 10.1128/AAC.02565-15. Print 2016 Jun.

  PMID: 27001822 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Infections

Study Officials

• Ann-Marie Chaftari, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: February 27, 2012
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 18, 2016

Record last verified: 2016-04

Locations

US (1)