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Concentration of Antimicrobials in Catheter-lock Solutions (CONAN)

Primary Purpose

Catheter-Related Infections, Bacteremia.

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Vancomycin antimicrobial-lock solution

Teicoplanin antimicrobial-lock solution

Linezolid antimicrobial-lock solution

Daptomycin antimicrobial-lock solution

Tigecycline antimicrobial-lock solution

About this trial

This is an interventional treatment trial for Catheter-Related Infections focused on measuring Antibiotic-lock technique., In vivo antimicrobial concentration., Antimicrobial bioactivity.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Intravenous access port recently inserted (≤ 3 days of insertion).
Intravenous access port inserted more than 3 days before informed consent form signing patient. In this case, a blood sample from the catheter will be drawn for blood culture before administration of the antibiotic lock solution.
Informed Consent Form Signed.

Exclusion Criteria:

Patients with confirmed or suspected local or systemic infection related to the catheter.
Reported allergy or intolerance to the antibiotic employed for study lock solutions.
Patients receiving oral, intravenous or intramuscular antibiotic treatment at the moment of inclusion in the clinical trial.
Patients receiving oral, intravenous or subcutaneous anticoagulant treatment, in a higher dose than the one used for venous thrombosis prophylaxis at the moment of inclusion in the clinical trial.
Patients younger than 18 years old.
Pregnant women or women in nursing period.
Personal incapacity to subscribe the informed consent to participate in the clinical trial.

Patient Replacement Criteria:

All patients and/or their legal representatives will be inform that they can leave the clinical trial in whenever they wish to do it, without prejudice to their medical attention.

Also, according to the criteria of the principal investigator, a patient could be separated from the clinical trial. The reasons to separate a patient from the study and replace him/her are:

Severe adverse reaction that could threat the life of the patient.
Resolution of the patient or from his/her legal representative to abandon the study.
No attend to the extraction visit date.
Development of clinical inconveniences that may indicate to abandon the study in behalf of the patient.
While antibiotic lock solution is within the port, manipulation or use of the port for administration of any kind of medication or fluid.
Impossibility to extract 4 ml of the antibiotic lock solution from the port.
Impossibility to extract 5 ml of peripheral blood sample at the moment of extraction of the antibiotic lock solution.
Use of any of the prohibited medications during the antibiotic lock solution is inside the port.
Intentionally wish of the patient in abandoning the study before or after antibiotic lock solution has been administered, or while the antibiotic lock solution is inside the port.

All patients who abandon the study or would be separated from the study for the exposed reasons, will be replaced for new candidates who fulfil the inclusion criteria and have signed the informed consent form.

Sites / Locations

Clinica Universidad de Navarra

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Vancomycin antimicrobial-lock

Teicoplanin antimicrobial-lock

Linezolid antimicrobial-lock

Daptomycin antimicrobial-lock

Tigecycline antimicrobial-lock

Arm Description

Vancomycin antimicrobial-lock solution. Dosage: 2 mg/mL. Dosage form: liquid in syringe. Frequency: 1. Duration: from 1 to 10 days according to HPLC corrected by urea gradient.

Teicoplanin antimicrobial-lock solution. Dosage: 10 mg/mL. Dosage form: liquid in syringe. Frequency: 1. Duration: from 1 to 10 days according to HPLC corrected by urea gradient.

Linezolid antimicrobial-lock solution. Dosage: 1.8 mg/mL. Dosage form: liquid in syringe. Frequency: 1. Duration: from 1 to 10 days according to HPLC corrected by urea gradient.

Daptomycin antimicrobial-lock solution. Dosage: 5 mg/mL. Dosage form: liquid in syringe. Frequency: 1. Duration: from 1 to 10 days according to HPLC corrected by urea gradient.

Tigecycline antimicrobial-lock solution. Dosage: 4.5 mg/mL. Dosage form: liquid in syringe. Frequency: 1. Duration: from 1 to 10 days according to HPLC corrected by urea gradient.

Outcomes

Primary Outcome Measures

Antimicrobial concentration of catheter-lock solutions at the end of port indwelling time.

Secondary Outcome Measures

Bioactivity of antimicrobials in lock solutions at the end of port indwelling time.

Anticoagulant activity of antimicrobial-lock solutions at the end of port indwelling time.

Full Information

NCT ID

NCT01592032

First Posted

April 24, 2012

Last Updated

February 18, 2015

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

University of Navarrra Hospital (Clinica Universitaria)

1. Study Identification

Unique Protocol Identification Number

NCT01592032

Brief Title

Concentration of Antimicrobials in Catheter-lock Solutions

Acronym

CONAN

Official Title

Concentration and Antibiotic Activity in Antibiotic Lock Solutions

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

University of Navarrra Hospital (Clinica Universitaria)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The antibiotic lock technique (ALT) is used as local treatment for Catheter-Related Bacteremia (CRB). It consists in the administration of a concentrated antimicrobial solution with a calculated volume to fill the lumen of the catheter. The lock solution is indwelled within the catheter for a defined period of hours or days before been removed. Currently, the Infectious Diseases Society of America (IDSA) Guidelines for treatment and management of CRB, recommends to change the antibiotic solution every 24 hours. The investigators expect to determine the stability of the concentration of vancomycin, teicoplanin, linezolid, daptomycin and tigecycline used in lock solutions, and thus to assay the optimal timeframe that the concentration of antibiotic used in lock solution keeps its in vivo antimicrobial activity. Study Hypothesis: An antibiotic lock solution maintains in vivo concentration and antimicrobial activity for at least 10 days after its infusion inside a subcutaneous port catheter.

Detailed Description

Primary Objective: Assess the antimicrobial concentration of catheter-lock solutions at the end of port indwelling time. Secondary Objectives: 1) Assess bioactivity of antimicrobials in lock solutions at the end of port indwelling time. 2) Assess anticoagulant activity of antimicrobial-lock solutions at the end of port indwelling time. Methods: Randomized, open, block allocation according to time of indwelling of the antimicrobial-lock within the ports, unicentric, clinical trial in patients older than 18 years old with a venous port implanted at Clínica Universidad de Navarra. Intevention: Randomization of 5 patients into one of five antimicrobial-lock solution arms for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. Any study arm can be stopped at any time from day 1 to day 10, in case of antimicrobial concentration would be less than 1 mg/mL. At the end of each antimicrobial lock time frame of ports (1, 3, 5, 7 and 10 days), the antimicrobial concentration will be determined by high performance liquid chromatography (HPLC) and corrected by urea gradient. The cut-off for the median antimicrobial concentration is 1 mg/mL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Catheter-Related Infections, Bacteremia.

Keywords

Antibiotic-lock technique., In vivo antimicrobial concentration., Antimicrobial bioactivity.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vancomycin antimicrobial-lock

Arm Type

Experimental

Arm Description

Vancomycin antimicrobial-lock solution. Dosage: 2 mg/mL. Dosage form: liquid in syringe. Frequency: 1. Duration: from 1 to 10 days according to HPLC corrected by urea gradient.

Arm Title

Teicoplanin antimicrobial-lock

Arm Type

Experimental

Arm Description

Teicoplanin antimicrobial-lock solution. Dosage: 10 mg/mL. Dosage form: liquid in syringe. Frequency: 1. Duration: from 1 to 10 days according to HPLC corrected by urea gradient.

Arm Title

Linezolid antimicrobial-lock

Arm Type

Experimental

Arm Description

Linezolid antimicrobial-lock solution. Dosage: 1.8 mg/mL. Dosage form: liquid in syringe. Frequency: 1. Duration: from 1 to 10 days according to HPLC corrected by urea gradient.

Arm Title

Daptomycin antimicrobial-lock

Arm Type

Experimental

Arm Description

Daptomycin antimicrobial-lock solution. Dosage: 5 mg/mL. Dosage form: liquid in syringe. Frequency: 1. Duration: from 1 to 10 days according to HPLC corrected by urea gradient.

Arm Title

Tigecycline antimicrobial-lock

Arm Type

Experimental

Arm Description

Tigecycline antimicrobial-lock solution. Dosage: 4.5 mg/mL. Dosage form: liquid in syringe. Frequency: 1. Duration: from 1 to 10 days according to HPLC corrected by urea gradient.

Intervention Type

Drug

Intervention Name(s)

Vancomycin antimicrobial-lock solution

Other Intervention Name(s)

vancomycin: vancomicina sala 500 mg vial., sodium heparin 1%, 5000 IU/5ml., sodium chloride 0,9% 10 ml vial.

Intervention Description

Randomization of 5 patients into vancomycin antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.

Intervention Type

Drug

Intervention Name(s)

Teicoplanin antimicrobial-lock solution

Other Intervention Name(s)

teicoplanin: targocid 200 mg vial., sodium heparin 1%, 5000 IU/5ml., sodium chloride 0,9% 10 ml vial.

Intervention Description

Randomization of 5 patients into teicoplanin antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.

Intervention Type

Drug

Intervention Name(s)

Linezolid antimicrobial-lock solution

Other Intervention Name(s)

linezolid: zyloxid 2 mg/ml, 300 ml vial., sodium heparin 1%, 5000 IU/5ml., sodium chloride 0,9% 10 ml vial.

Intervention Description

Randomization of 5 patients into linezolid antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.

Intervention Type

Drug

Intervention Name(s)

Daptomycin antimicrobial-lock solution

Other Intervention Name(s)

daptomycin: cubicin 350 mg vial., sodium heparin 1%, 5000 IU/5ml., lactated ringer´s solution 500 ml viaflo.

Intervention Description

Randomization of 5 patients into daptomycin antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.

Intervention Type

Drug

Intervention Name(s)

Tigecycline antimicrobial-lock solution

Other Intervention Name(s)

tigecycline: tygacil 50 mg vial., sodium chloride 0,9% 10 ml vial., sodium heparin 1%, 5000 IU/5ml.

Intervention Description

Randomization of 5 patients into tigecycline antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.

Primary Outcome Measure Information:

Title

Antimicrobial concentration of catheter-lock solutions at the end of port indwelling time.

Time Frame

1 to 10 days

Secondary Outcome Measure Information:

Title

Bioactivity of antimicrobials in lock solutions at the end of port indwelling time.

Time Frame

1 to 10 days

Title

Anticoagulant activity of antimicrobial-lock solutions at the end of port indwelling time.

Time Frame

1 to 10 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Intravenous access port recently inserted (≤ 3 days of insertion). Intravenous access port inserted more than 3 days before informed consent form signing patient. In this case, a blood sample from the catheter will be drawn for blood culture before administration of the antibiotic lock solution. Informed Consent Form Signed. Exclusion Criteria: Patients with confirmed or suspected local or systemic infection related to the catheter. Reported allergy or intolerance to the antibiotic employed for study lock solutions. Patients receiving oral, intravenous or intramuscular antibiotic treatment at the moment of inclusion in the clinical trial. Patients receiving oral, intravenous or subcutaneous anticoagulant treatment, in a higher dose than the one used for venous thrombosis prophylaxis at the moment of inclusion in the clinical trial. Patients younger than 18 years old. Pregnant women or women in nursing period. Personal incapacity to subscribe the informed consent to participate in the clinical trial. Patient Replacement Criteria: All patients and/or their legal representatives will be inform that they can leave the clinical trial in whenever they wish to do it, without prejudice to their medical attention. Also, according to the criteria of the principal investigator, a patient could be separated from the clinical trial. The reasons to separate a patient from the study and replace him/her are: Severe adverse reaction that could threat the life of the patient. Resolution of the patient or from his/her legal representative to abandon the study. No attend to the extraction visit date. Development of clinical inconveniences that may indicate to abandon the study in behalf of the patient. While antibiotic lock solution is within the port, manipulation or use of the port for administration of any kind of medication or fluid. Impossibility to extract 4 ml of the antibiotic lock solution from the port. Impossibility to extract 5 ml of peripheral blood sample at the moment of extraction of the antibiotic lock solution. Use of any of the prohibited medications during the antibiotic lock solution is inside the port. Intentionally wish of the patient in abandoning the study before or after antibiotic lock solution has been administered, or while the antibiotic lock solution is inside the port. All patients who abandon the study or would be separated from the study for the exposed reasons, will be replaced for new candidates who fulfil the inclusion criteria and have signed the informed consent form.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JOSE L DEL POZO, MD. Ph. D.

Organizational Affiliation