Catheter-Related InfectionsPhase 4CONANNCT01592032
Concentration of Antimicrobials in Catheter-lock Solutions
A Phase 4 study testing Vancomycin antimicrobial-lock solution, Teicoplanin antimicrobial-lock solution and Linezolid antimicrobial-lock solution in people with Catheter-Related Infections and Bacteremia., run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections, Bacteremia.
- What is being tested?
- Vancomycin antimicrobial-lock solution, Teicoplanin antimicrobial-lock solution and Linezolid antimicrobial-lock solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSpain
- Study dates
- May 2012to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concentration and Antibiotic Activity in Antibiotic Lock Solutions
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.
Read more
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.
Read the 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.
- Conditions
- Catheter-Related Infections, Bacteremia.
- Being tested
- Vancomycin antimicrobial-lock solution, Teicoplanin antimicrobial-lock solution, Linezolid antimicrobial-lock solution, Daptomycin antimicrobial-lock solution, Tigecycline antimicrobial-lock solution
- Keywords
- Antibiotic-lock technique., In vivo antimicrobial concentration., Antimicrobial bioactivity.
- Medical subject headings
- Catheter-Related Infections, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin antimicrobial-lock solutionDrug
Also called vancomycin: vancomicina sala 500 mg vial., sodium heparin 1%, 5000 IU/5ml., sodium chloride 0,9% 10 ml vial.
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.
Teicoplanin antimicrobial-lock solutionDrug
Also called teicoplanin: targocid 200 mg vial., sodium heparin 1%, 5000 IU/5ml., sodium chloride 0,9% 10 ml vial.
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.
Linezolid antimicrobial-lock solutionDrug
Also called linezolid: zyloxid 2 mg/ml, 300 ml vial., sodium heparin 1%, 5000 IU/5ml., sodium chloride 0,9% 10 ml vial.
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.
Daptomycin antimicrobial-lock solutionDrug
Also called daptomycin: cubicin 350 mg vial., sodium heparin 1%, 5000 IU/5ml., lactated ringer´s solution 500 ml viaflo.
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.
Tigecycline antimicrobial-lock solutionDrug
Also called tigecycline: tygacil 50 mg vial., sodium chloride 0,9% 10 ml vial., sodium heparin 1%, 5000 IU/5ml.
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.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin antimicrobial-lock | Experimental | 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. Receives: Drug: Vancomycin antimicrobial-lock solution |
| Teicoplanin antimicrobial-lock | Experimental | 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. Receives: Drug: Teicoplanin antimicrobial-lock solution |
| Linezolid antimicrobial-lock | Experimental | 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. Receives: Drug: Linezolid antimicrobial-lock solution |
| Daptomycin antimicrobial-lock | Experimental | 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. Receives: Drug: Daptomycin antimicrobial-lock solution |
| Tigecycline antimicrobial-lock | Experimental | 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. Receives: Drug: Tigecycline antimicrobial-lock solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial concentration of catheter-lock solutions at the end of port indwelling time.
Measured: 1 to 10 days
Secondary outcomes (2)
Bioactivity of antimicrobials in lock solutions at the end of port indwelling time.
Measured: 1 to 10 days
Anticoagulant activity of antimicrobial-lock solutions at the end of port indwelling time.
Measured: 1 to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2015
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarrra Hospital (Clinica Universitaria)
- Responsible party
- Principal investigator, José Luis del Pozo, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- JOSE L DEL POZO, MD. Ph. D., Principal investigator, Clinica Universidad de NavarraCESAR E BUSTOS, MD., Study chair, Clinica Universidad de NavarraAITZIBER AGUINAGA, Pharm. D., Study chair, Clinica Universidad de NavarraJOSE R YUSTE, MD. Ph.D., Study chair, Clinica Universidad de NavarraJOSE R AZANZA, MD. Ph.D., Study chair, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592032
- Sponsor's protocol ID
- CAS110775
- Other IDs
- 2010-023814-29
- Acronym
- CONAN
- Status last verified
- Feb 2015
- First submitted
- 24 Apr 2012
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Del Pozo JL, Rodil R, Aguinaga A, Yuste JR, Bustos C, Montero A, Espinosa G, Garcia-Fernandez N. Daptomycin lock therapy for grampositive long-term catheter-related bloodstream infections. Int J Clin Pract. 2012 Mar;66(3):305-8. doi: 10.1111/j.1742-1241.2011.02830.x.
PubMed 22340450Del Pozo JL, Garcia Cenoz M, Hernaez S, Martinez A, Serrera A, Aguinaga A, Alonso M, Leiva J. Effectiveness of teicoplanin versus vancomycin lock therapy in the treatment of port-related coagulase-negative staphylococci bacteraemia: a prospective case-series analysis. Int J Antimicrob Agents. 2009 Nov;34(5):482-5. doi: 10.1016/j.ijantimicag.2009.06.020. Epub 2009 Aug 26.
PubMed 19713086del Pozo JL. Role of antibiotic lock therapy for the treatment of catheter-related bloodstream infections. Int J Artif Organs. 2009 Sep;32(9):678-88. doi: 10.1177/039139880903200918.
PubMed 19882553Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.
PubMed 19489710del Pozo JL, Patel R. The challenge of treating biofilm-associated bacterial infections. Clin Pharmacol Ther. 2007 Aug;82(2):204-9. doi: 10.1038/sj.clpt.6100247. Epub 2007 May 30.
PubMed 17538551Sherertz RJ, Boger MS, Collins CA, Mason L, Raad II. Comparative in vitro efficacies of various catheter lock solutions. Antimicrob Agents Chemother. 2006 May;50(5):1865-8. doi: 10.1128/AAC.50.5.1865-1868.2006.
PubMed 16641463Fennell JP, O'Donohoe M, Cormican M, Lynch M. Linezolid lock prophylaxis of central venous catheter infection. J Med Microbiol. 2008 Apr;57(Pt 4):534-535. doi: 10.1099/jmm.0.47665-0.
PubMed 18349379LaPlante KL, Mermel LA. In vitro activity of daptomycin and vancomycin lock solutions on staphylococcal biofilms in a central venous catheter model. Nephrol Dial Transplant. 2007 Aug;22(8):2239-46. doi: 10.1093/ndt/gfm141. Epub 2007 Apr 1.
PubMed 17403700Del Pozo JL, Alonso M, Serrera A, Hernaez S, Aguinaga A, Leiva J. Effectiveness of the antibiotic lock therapy for the treatment of port-related enterococci, Gram-negative, or Gram-positive bacilli bloodstream infections. Diagn Microbiol Infect Dis. 2009 Feb;63(2):208-12. doi: 10.1016/j.diagmicrobio.2008.10.004. Epub 2008 Nov 21.
PubMed 19026506Raad I, Hanna H, Jiang Y, Dvorak T, Reitzel R, Chaiban G, Sherertz R, Hachem R. Comparative activities of daptomycin, linezolid, and tigecycline against catheter-related methicillin-resistant Staphylococcus bacteremic isolates embedded in biofilm. Antimicrob Agents Chemother. 2007 May;51(5):1656-60. doi: 10.1128/AAC.00350-06. Epub 2007 Mar 12.
PubMed 17353249Robinson JL, Tawfik G, Saxinger L, Stang L, Etches W, Lee B. Stability of heparin and physical compatibility of heparin/antibiotic solutions in concentrations appropriate for antibiotic lock therapy. J Antimicrob Chemother. 2005 Nov;56(5):951-3. doi: 10.1093/jac/dki311. Epub 2005 Sep 9.
PubMed 16155063Labthavikul P, Petersen PJ, Bradford PA. In vitro activity of tigecycline against Staphylococcus epidermidis growing in an adherent-cell biofilm model. Antimicrob Agents Chemother. 2003 Dec;47(12):3967-9. doi: 10.1128/AAC.47.12.3967-3969.2003.
PubMed 14638511Bustos C, Yuste JR, Aguinaga A, Parra A, Carmona-Torre F, Azanza JR, Lacasa C, Del Pozo JL. Timing of Antimicrobial Lock Replacement for Gram-Positive Port Infections: Results of a Randomized Trial. Antibiotics (Basel). 2026 Feb 2;15(2):157. doi: 10.3390/antibiotics15020157.
PubMed 41750455
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentration and Antibiotic Activity in Antibiotic Lock Solutions
- ClinicalTrials.gov ID
- NCT01592032
- Acronym / sponsor ID
- CONAN / CAS110775
- Conditions
- Catheter-Related Infections, Bacteremia.
- Keywords
- Antibiotic-lock technique., In vivo antimicrobial concentration., Antimicrobial bioactivity.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- University of Navarrra Hospital (Clinica Universitaria)
- Study start
- May 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 4 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Vancomycin antimicrobial-lock | Experimental | Drug: Vancomycin antimicrobial-lock solutionVancomycin 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 | Experimental | Drug: Teicoplanin antimicrobial-lock solutionTeicoplanin 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 | Experimental | Drug: Linezolid antimicrobial-lock solutionLinezolid 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 | Experimental | Drug: Daptomycin antimicrobial-lock solutionDaptomycin 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 | Experimental | Drug: Tigecycline antimicrobial-lock solutionTigecycline 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin antimicrobial-lock solutionAlso: vancomycin: vancomicina sala 500 mg vial., sodium heparin 1%, 5000 IU/5ml., sodium chloride 0,9% 10 ml vial.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. | Drug | Vancomycin antimicrobial-lock |
| Teicoplanin antimicrobial-lock solutionAlso: teicoplanin: targocid 200 mg vial., sodium heparin 1%, 5000 IU/5ml., sodium chloride 0,9% 10 ml vial.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. | Drug | Teicoplanin antimicrobial-lock |
| Linezolid antimicrobial-lock solutionAlso: linezolid: zyloxid 2 mg/ml, 300 ml vial., sodium heparin 1%, 5000 IU/5ml., sodium chloride 0,9% 10 ml vial.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. | Drug | Linezolid antimicrobial-lock |
| Daptomycin antimicrobial-lock solutionAlso: daptomycin: cubicin 350 mg vial., sodium heparin 1%, 5000 IU/5ml., lactated ringer´s solution 500 ml viaflo.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. | Drug | Daptomycin antimicrobial-lock |
| Tigecycline antimicrobial-lock solutionAlso: tigecycline: tygacil 50 mg vial., sodium chloride 0,9% 10 ml vial., sodium heparin 1%, 5000 IU/5ml.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. | Drug | Tigecycline antimicrobial-lock |
Primary outcome
Antimicrobial concentration of catheter-lock solutions at the end of port indwelling time.
Time frame: 1 to 10 days
2 secondary outcomes
Bioactivity of antimicrobials in lock solutions at the end of port indwelling time.
Time frame: 1 to 10 days
Anticoagulant activity of antimicrobial-lock solutions at the end of port indwelling time.
Time frame: 1 to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
- Results publication: PubMed 22340450Del Pozo JL, Rodil R, Aguinaga A, Yuste JR, Bustos C, Montero A, Espinosa G, Garcia-Fernandez N. Daptomycin lock therapy for grampositive long-term catheter-related bloodstream infections. Int J Clin Pract. 2012 Mar;66(3):305-8. doi: 10.1111/j.1742-1241.2011.02830.x.
- Results publication: PubMed 19713086Del Pozo JL, Garcia Cenoz M, Hernaez S, Martinez A, Serrera A, Aguinaga A, Alonso M, Leiva J. Effectiveness of teicoplanin versus vancomycin lock therapy in the treatment of port-related coagulase-negative staphylococci bacteraemia: a prospective case-series analysis. Int J Antimicrob Agents. 2009 Nov;34(5):482-5. doi: 10.1016/j.ijantimicag.2009.06.020. Epub 2009 Aug 26.
- Results publication: PubMed 19882553del Pozo JL. Role of antibiotic lock therapy for the treatment of catheter-related bloodstream infections. Int J Artif Organs. 2009 Sep;32(9):678-88. doi: 10.1177/039139880903200918.
- Results publication: PubMed 19489710Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.
- Results publication: PubMed 17538551del Pozo JL, Patel R. The challenge of treating biofilm-associated bacterial infections. Clin Pharmacol Ther. 2007 Aug;82(2):204-9. doi: 10.1038/sj.clpt.6100247. Epub 2007 May 30.
- Results publication: PubMed 16641463Sherertz RJ, Boger MS, Collins CA, Mason L, Raad II. Comparative in vitro efficacies of various catheter lock solutions. Antimicrob Agents Chemother. 2006 May;50(5):1865-8. doi: 10.1128/AAC.50.5.1865-1868.2006.
- Results publication: PubMed 18349379Fennell JP, O'Donohoe M, Cormican M, Lynch M. Linezolid lock prophylaxis of central venous catheter infection. J Med Microbiol. 2008 Apr;57(Pt 4):534-535. doi: 10.1099/jmm.0.47665-0.
- Results publication: PubMed 17403700LaPlante KL, Mermel LA. In vitro activity of daptomycin and vancomycin lock solutions on staphylococcal biofilms in a central venous catheter model. Nephrol Dial Transplant. 2007 Aug;22(8):2239-46. doi: 10.1093/ndt/gfm141. Epub 2007 Apr 1.
- Results publication: PubMed 19026506Del Pozo JL, Alonso M, Serrera A, Hernaez S, Aguinaga A, Leiva J. Effectiveness of the antibiotic lock therapy for the treatment of port-related enterococci, Gram-negative, or Gram-positive bacilli bloodstream infections. Diagn Microbiol Infect Dis. 2009 Feb;63(2):208-12. doi: 10.1016/j.diagmicrobio.2008.10.004. Epub 2008 Nov 21.
- Results publication: PubMed 17353249Raad I, Hanna H, Jiang Y, Dvorak T, Reitzel R, Chaiban G, Sherertz R, Hachem R. Comparative activities of daptomycin, linezolid, and tigecycline against catheter-related methicillin-resistant Staphylococcus bacteremic isolates embedded in biofilm. Antimicrob Agents Chemother. 2007 May;51(5):1656-60. doi: 10.1128/AAC.00350-06. Epub 2007 Mar 12.
- Results publication: PubMed 16155063Robinson JL, Tawfik G, Saxinger L, Stang L, Etches W, Lee B. Stability of heparin and physical compatibility of heparin/antibiotic solutions in concentrations appropriate for antibiotic lock therapy. J Antimicrob Chemother. 2005 Nov;56(5):951-3. doi: 10.1093/jac/dki311. Epub 2005 Sep 9.
- Results publication: PubMed 14638511Labthavikul P, Petersen PJ, Bradford PA. In vitro activity of tigecycline against Staphylococcus epidermidis growing in an adherent-cell biofilm model. Antimicrob Agents Chemother. 2003 Dec;47(12):3967-9. doi: 10.1128/AAC.47.12.3967-3969.2003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSE L DEL POZO, MD. Ph. D. principal investigator
Clinica Universidad de Navarra
CESAR E BUSTOS, MD. study chair
Clinica Universidad de Navarra
AITZIBER AGUINAGA, Pharm. D. study chair
Clinica Universidad de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin antimicrobial-lock solution, Teicoplanin antimicrobial-lock solution and Linezolid antimicrobial-lock solution in people with Catheter-Related Infections and Bacteremia., run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial concentration of catheter-lock solutions at the end of port indwelling time. (time frame: 1 to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01592032, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2015.