BacteremiaPhase 2/3NCT00122642
Alcohol Locks for the Prevention of Tunneled Catheter-related Infections
A Phase 2/3 study testing Alcohol-lock in people with Bacteremia, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
In modern-day medicine, the use of central venous catheters has become unavoidable. However, their use does not come without risk. It puts patients in danger of infectious complications (catheter-related infections [CRI]), the most important of which is catheter-related bloodstream infection (CRBSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- What is being tested?
- Alcohol-lock
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2005to Sep 2009
- Phase
- Phase 2/3
- 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
- Patient at least 18 years old
- Admitted to the haematology department
- Had a tunnelled central venous catheter inserted in the preceding 72 hours
Who cannot join
- Known allergy to alcohol or active use of metronidazole (or related 2-nitroimidazole compounds) or disulfiram (Antabuse)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Daily Alcohol Locks for the Prevention of Tunneled Catheter Infection in Patients With Haematological Disease. Randomised Placebo Controlled Trial
In modern-day medicine, the use of central venous catheters has become unavoidable. However, their use does not come without risk. It puts patients in danger of infectious complications (catheter-related infections [CRI]), the most important of which is catheter-related bloodstream infection (CRBSI). CRBSI is associated with a significant increase in hospital stay and, therefore, cost of patient management, morbidity, and probably also mortality. There still is an urgent need for effective, cheap and easy to implement measures to prevent CRI that are without risk of developing antibiotic resistance.
During use, bacteria can colonize the inner surface of the catheter. This endoluminal route of infection can be prevented to some extent when an antibiotic solution is instilled in the catheter for a long enough time and on a regular basis. However, to avoid resistance from occurring, the use of antibiotics for infection prevention should remain exceptional.
Read more
The use of a non-toxic antiseptic might be a better alternative. Recently, the use of an alcohol lock solution was suggested as a promising way to prevent CRBSI and the compatibility of polyurethane and silicone catheters submerged in an alcohol solution was publicized with no biomechanical or structural changes detected after 9 weeks of immersion. The major advantage of an alcohol lock solution would be the broad antimicrobial spectrum without the risk of compromising future antibiotic treatment as, in contrast to the use of an antibiotic lock, the development of antibiotic resistance is not of concern. Furthermore it would be cheap and universally available.
In this randomised study, the efficacy of a 70% alcohol lock solution for the prevention of CRBSI will be compared with placebo when applied for 15 minutes per day.
Read the detailed description
In modern-day medicine, the use of intravascular catheters has become unavoidable. In the United States, hospitals and clinics purchase more than 150 million intravascular devices each year of which more than 5 million are central venous catheters. However, their use does not come without risk. It puts patients in danger of mechanical, thrombotic and infectious complications (catheter-related infections [CRI]), the most important of which is catheter-related bloodstream infection (CRBSI). CRBSI is associated with a significant increase in hospital stay and, therefore, cost of patient management, morbidity and probably also mortality. The increase in expenses was estimated to be 15,965 US dollars per patient with a CRBSI in 1994 and even 56,167 US dollars in another more recent study.
It is clear that the prevention of CRI is of utmost importance and will help to decrease patient suffering as well as cost of patient management. Extensive and detailed evidence-based recommendations for the prevention of CRI were recently published. However, many topics remain unresolved and there still is an urgent need for effective, cheap and easy to implement preventive measures that are without risk of developing antibiotic resistance.
Catheters can become colonized with microorganisms through exoluminal (catheter insertion site) or endoluminal (hub and infusates) routes. It has been shown that, the longer a catheter remains in place, the more important the endoluminal route becomes. The endoluminal route of infection can be prevented to some extent when an antibiotic solution is instilled in the catheter for a long enough time and on a regular basis. However, to avoid resistance from occurring, the use of antibiotics in such a lock for infection prevention should remain exceptional. Although there is evidence to support the concept, methodologically appropriate clinical data on the use of antiseptic solutions for this purpose are still awaited.
Recently, the use of an alcohol lock solution was suggested as a promising way to prevent CRBSI and the compatibility of polyurethane and silicone catheters submerged in an alcohol solution was publicized with no biomechanical or structural changes detected after 9 weeks of immersion. The major advantage of an alcohol lock solution would be the broad antimicrobial spectrum without the risk of compromising future antibiotic treatment as, in contrast to the use of an antibiotic lock, the development of antibiotic resistance is not of concern. Furthermore it would be cheap and universally available.
In this randomised study the efficacy of a 70% alcohol lock solution for the prevention of CRBSI will be compared with placebo when applied for 15 minutes per day.
- Conditions
- Bacteremia
- Being tested
- Alcohol-lock, placebo-lock
- Keywords
- catheterization, Catheters, Indwelling
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol-lockProcedure or surgery
The intervention is the instillation of ethanol 70% solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.
placebo-lockDrug
The intervention is the instillation of placebo solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The intervention is the instillation of ethanol 70% solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes for patients not in the hospital. Receives: Procedure: Alcohol-lock |
| 2 | Placebo comparator | The intervention is the instillation of placebo solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital. Receives: Drug: placebo-lock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoluminal catheter related bacteremia
Measured: at time of catheter removal
Secondary outcomes (5)
All catheter-related bacteremias with differential time to positivity (DTTP) > 2 hours
Measured: at time of catheter removal
Catheter survival time
Measured: at time of catheter removal
Vancomycin and linezolid use
Measured: at time of catheter removal
Incidence of positive catheter tip cultures
Measured: at time of catheter removal
Incidence of bacteremia/fungemia (catheter-related or not)
Measured: at time of catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Nuts Ohra
- Investigators
- Bart JA Rijnders, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122642
- Sponsor's protocol ID
- AL-01
- Other IDs
- SNO-T-07-57
- Status last verified
- Sep 2009
- First submitted
- 19 Jul 2005
- Last updated
- 25 Sep 2009
- Results posted
- No
Publications
Mermel LA, Farr BM, Sherertz RJ, Raad II, O'Grady N, Harris JS, Craven DE; Infectious Diseases Society of America; American College of Critical Care Medicine; Society for Healthcare Epidemiology of America. Guidelines for the management of intravascular catheter-related infections. Clin Infect Dis. 2001 May 1;32(9):1249-72. doi: 10.1086/320001. Epub 2001 Apr 3. No abstract available.
PubMed 11303260Digiovine B, Chenoweth C, Watts C, Higgins M. The attributable mortality and costs of primary nosocomial bloodstream infections in the intensive care unit. Am J Respir Crit Care Med. 1999 Sep;160(3):976-81. doi: 10.1164/ajrccm.160.3.9808145.
PubMed 10471627Rello J, Ochagavia A, Sabanes E, Roque M, Mariscal D, Reynaga E, Valles J. Evaluation of outcome of intravenous catheter-related infections in critically ill patients. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1027-30. doi: 10.1164/ajrccm.162.3.9911093.
PubMed 10988125Renaud B, Brun-Buisson C; ICU-Bacteremia Study Group. Outcomes of primary and catheter-related bacteremia. A cohort and case-control study in critically ill patients. Am J Respir Crit Care Med. 2001 Jun;163(7):1584-90. doi: 10.1164/ajrccm.163.7.9912080.
PubMed 11401878Dimick JB, Pelz RK, Consunji R, Swoboda SM, Hendrix CW, Lipsett PA. Increased resource use associated with catheter-related bloodstream infection in the surgical intensive care unit. Arch Surg. 2001 Feb;136(2):229-34. doi: 10.1001/archsurg.136.2.229.
PubMed 11177147O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002 Aug 9;51(RR-10):1-29.
PubMed 12233868Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement. J Infect Dis. 1993 Aug;168(2):400-7. doi: 10.1093/infdis/168.2.400.
PubMed 8335977Carratala J, Niubo J, Fernandez-Sevilla A, Juve E, Castellsague X, Berlanga J, Linares J, Gudiol F. Randomized, double-blind trial of an antibiotic-lock technique for prevention of gram-positive central venous catheter-related infection in neutropenic patients with cancer. Antimicrob Agents Chemother. 1999 Sep;43(9):2200-4. doi: 10.1128/AAC.43.9.2200.
PubMed 10471564Schwartz C, Henrickson KJ, Roghmann K, Powell K. Prevention of bacteremia attributed to luminal colonization of tunneled central venous catheters with vancomycin-susceptible organisms. J Clin Oncol. 1990 Sep;8(9):1591-7. doi: 10.1200/JCO.1990.8.9.1591.
PubMed 2202792Dogra GK, Herson H, Hutchison B, Irish AB, Heath CH, Golledge C, Luxton G, Moody H. Prevention of tunneled hemodialysis catheter-related infections using catheter-restricted filling with gentamicin and citrate: a randomized controlled study. J Am Soc Nephrol. 2002 Aug;13(8):2133-9. doi: 10.1097/01.asn.0000022890.29656.22.
PubMed 12138146Henrickson KJ, Axtell RA, Hoover SM, Kuhn SM, Pritchett J, Kehl SC, Klein JP. Prevention of central venous catheter-related infections and thrombotic events in immunocompromised children by the use of vancomycin/ciprofloxacin/heparin flush solution: A randomized, multicenter, double-blind trial. J Clin Oncol. 2000 Mar;18(6):1269-78. doi: 10.1200/JCO.2000.18.6.1269.
PubMed 10715297Chatzinikolaou I, Zipf TF, Hanna H, Umphrey J, Roberts WM, Sherertz R, Hachem R, Raad I. Minocycline-ethylenediaminetetraacetate lock solution for the prevention of implantable port infections in children with cancer. Clin Infect Dis. 2003 Jan 1;36(1):116-9. doi: 10.1086/344952. Epub 2002 Dec 11.
PubMed 12491212Allon M. Prophylaxis against dialysis catheter-related bacteremia with a novel antimicrobial lock solution. Clin Infect Dis. 2003 Jun 15;36(12):1539-44. doi: 10.1086/375234. Epub 2003 Jun 6.
PubMed 12802753Maki DG, Crnich CJ, Safdar N. Successful use of a 25% Alcohol Lock Solution for Prevention of Recurrent CVC-Related Bloodstream Infection in a patient on Home TNA. 42nd ICAAC Abstracts, American Society for Microbiology, September 27 - 30, 2002, San Diego, CA, page 320 . 2002.
A.Aiyangar, W.C.Crone, C.J.Crnich DGM. Effect of Ethanol on the Mechanical Properties of Polyurethane Catheters. Proceedings of the 2002 SEM Annual Conference and Exposition on Experimental and Applied Mechanics . 2002.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Daily Alcohol Locks for the Prevention of Tunneled Catheter Infection in Patients With Haematological Disease. Randomised Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00122642
- Acronym / sponsor ID
- AL-01
- Conditions
- Bacteremia
- Keywords
- catheterization, Catheters, Indwelling
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Stichting Nuts Ohra
- Study start
- Aug 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Jul 2005 (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.
In modern-day medicine, the use of central venous catheters has become unavoidable. However, their use does not come without risk. It puts patients in danger of infectious complications (catheter-related infections [CRI]), the most important of which is catheter-related bloodstream infection (CRBSI). CRBSI is associated with a significant increase in hospital stay and, therefore, cost of patient management, morbidity, and probably also mortality. There still is an urgent need for effective, cheap and easy to implement measures to prevent CRI that are without risk of developing antibiotic resistance.
During use, bacteria can colonize the inner surface of the catheter. This endoluminal route of infection can be prevented to some extent when an antibiotic solution is instilled in the catheter for a long enough time and on a regular basis. However, to avoid resistance from occurring, the use of antibiotics for infection prevention should remain exceptional.
The use of a non-toxic antiseptic might be a better alternative. Recently, the use of an alcohol lock solution was suggested as a promising way to prevent CRBSI and the compatibility of polyurethane and silicone catheters submerged in an alcohol solution was publicized with no biomechanical or structural changes detected after 9 weeks of immersion. The major advantage of an alcohol lock solution would be the broad antimicrobial spectrum without the risk of compromising future antibiotic treatment as, in contrast to the use of an antibiotic lock, the development of antibiotic resistance is not of concern. Furthermore it would be cheap and universally available.
In this randomised study, the efficacy of a 70% alcohol lock solution for the prevention of CRBSI will be compared with placebo when applied for 15 minutes per day.
Detailed description
In modern-day medicine, the use of intravascular catheters has become unavoidable. In the United States, hospitals and clinics purchase more than 150 million intravascular devices each year of which more than 5 million are central venous catheters. However, their use does not come without risk. It puts patients in danger of mechanical, thrombotic and infectious complications (catheter-related infections [CRI]), the most important of which is catheter-related bloodstream infection (CRBSI). CRBSI is associated with a significant increase in hospital stay and, therefore, cost of patient management, morbidity and probably also mortality. The increase in expenses was estimated to be 15,965 US dollars per patient with a CRBSI in 1994 and even 56,167 US dollars in another more recent study.
It is clear that the prevention of CRI is of utmost importance and will help to decrease patient suffering as well as cost of patient management. Extensive and detailed evidence-based recommendations for the prevention of CRI were recently published. However, many topics remain unresolved and there still is an urgent need for effective, cheap and easy to implement preventive measures that are without risk of developing antibiotic resistance.
Catheters can become colonized with microorganisms through exoluminal (catheter insertion site) or endoluminal (hub and infusates) routes. It has been shown that, the longer a catheter remains in place, the more important the endoluminal route becomes. The endoluminal route of infection can be prevented to some extent when an antibiotic solution is instilled in the catheter for a long enough time and on a regular basis. However, to avoid resistance from occurring, the use of antibiotics in such a lock for infection prevention should remain exceptional. Although there is evidence to support the concept, methodologically appropriate clinical data on the use of antiseptic solutions for this purpose are still awaited.
Recently, the use of an alcohol lock solution was suggested as a promising way to prevent CRBSI and the compatibility of polyurethane and silicone catheters submerged in an alcohol solution was publicized with no biomechanical or structural changes detected after 9 weeks of immersion. The major advantage of an alcohol lock solution would be the broad antimicrobial spectrum without the risk of compromising future antibiotic treatment as, in contrast to the use of an antibiotic lock, the development of antibiotic resistance is not of concern. Furthermore it would be cheap and universally available.
In this randomised study the efficacy of a 70% alcohol lock solution for the prevention of CRBSI will be compared with placebo when applied for 15 minutes per day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Alcohol-lockThe intervention is the instillation of ethanol 70% solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes for patients not in the hospital. |
| 2 | Placebo comparator | Drug: placebo-lockThe intervention is the instillation of placebo solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient at least 18 years old
- Admitted to the haematology department
- Had a tunnelled central venous catheter inserted in the preceding 72 hours
Key exclusion criteria (1 listed)
- Known allergy to alcohol or active use of metronidazole (or related 2-nitroimidazole compounds) or disulfiram (Antabuse)
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 |
|---|---|---|
| Alcohol-lockThe intervention is the instillation of ethanol 70% solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital. | Procedure or surgery | 1 |
| placebo-lockThe intervention is the instillation of placebo solution in the catheter lumen (or lumina) for 15minutes per day during hospital stay and for 15minutes per week for patients not in the hospital. | Drug | 2 |
Primary outcome
Endoluminal catheter related bacteremia
Time frame: at time of catheter removal
5 secondary outcomes
All catheter-related bacteremias with differential time to positivity (DTTP) > 2 hours
Time frame: at time of catheter removal
Catheter survival time
Time frame: at time of catheter removal
Vancomycin and linezolid use
Time frame: at time of catheter removal
Incidence of positive catheter tip cultures
Time frame: at time of catheter removal
Incidence of bacteremia/fungemia (catheter-related or not)
Time frame: at time of catheter removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
- Background: PubMed 11303260Mermel LA, Farr BM, Sherertz RJ, Raad II, O'Grady N, Harris JS, Craven DE; Infectious Diseases Society of America; American College of Critical Care Medicine; Society for Healthcare Epidemiology of America. Guidelines for the management of intravascular catheter-related infections. Clin Infect Dis. 2001 May 1;32(9):1249-72. doi: 10.1086/320001. Epub 2001 Apr 3. No abstract available.
- Background: PubMed 10471627Digiovine B, Chenoweth C, Watts C, Higgins M. The attributable mortality and costs of primary nosocomial bloodstream infections in the intensive care unit. Am J Respir Crit Care Med. 1999 Sep;160(3):976-81. doi: 10.1164/ajrccm.160.3.9808145.
- Background: PubMed 10988125Rello J, Ochagavia A, Sabanes E, Roque M, Mariscal D, Reynaga E, Valles J. Evaluation of outcome of intravenous catheter-related infections in critically ill patients. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1027-30. doi: 10.1164/ajrccm.162.3.9911093.
- Background: PubMed 11401878Renaud B, Brun-Buisson C; ICU-Bacteremia Study Group. Outcomes of primary and catheter-related bacteremia. A cohort and case-control study in critically ill patients. Am J Respir Crit Care Med. 2001 Jun;163(7):1584-90. doi: 10.1164/ajrccm.163.7.9912080.
- Background: PubMed 11177147Dimick JB, Pelz RK, Consunji R, Swoboda SM, Hendrix CW, Lipsett PA. Increased resource use associated with catheter-related bloodstream infection in the surgical intensive care unit. Arch Surg. 2001 Feb;136(2):229-34. doi: 10.1001/archsurg.136.2.229.
- Background: PubMed 12233868O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002 Aug 9;51(RR-10):1-29.
- Background: PubMed 8335977Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement. J Infect Dis. 1993 Aug;168(2):400-7. doi: 10.1093/infdis/168.2.400.
- Background: PubMed 10471564Carratala J, Niubo J, Fernandez-Sevilla A, Juve E, Castellsague X, Berlanga J, Linares J, Gudiol F. Randomized, double-blind trial of an antibiotic-lock technique for prevention of gram-positive central venous catheter-related infection in neutropenic patients with cancer. Antimicrob Agents Chemother. 1999 Sep;43(9):2200-4. doi: 10.1128/AAC.43.9.2200.
- Background: PubMed 2202792Schwartz C, Henrickson KJ, Roghmann K, Powell K. Prevention of bacteremia attributed to luminal colonization of tunneled central venous catheters with vancomycin-susceptible organisms. J Clin Oncol. 1990 Sep;8(9):1591-7. doi: 10.1200/JCO.1990.8.9.1591.
- Background: PubMed 12138146Dogra GK, Herson H, Hutchison B, Irish AB, Heath CH, Golledge C, Luxton G, Moody H. Prevention of tunneled hemodialysis catheter-related infections using catheter-restricted filling with gentamicin and citrate: a randomized controlled study. J Am Soc Nephrol. 2002 Aug;13(8):2133-9. doi: 10.1097/01.asn.0000022890.29656.22.
- Background: PubMed 10715297Henrickson KJ, Axtell RA, Hoover SM, Kuhn SM, Pritchett J, Kehl SC, Klein JP. Prevention of central venous catheter-related infections and thrombotic events in immunocompromised children by the use of vancomycin/ciprofloxacin/heparin flush solution: A randomized, multicenter, double-blind trial. J Clin Oncol. 2000 Mar;18(6):1269-78. doi: 10.1200/JCO.2000.18.6.1269.
- Background: PubMed 12491212Chatzinikolaou I, Zipf TF, Hanna H, Umphrey J, Roberts WM, Sherertz R, Hachem R, Raad I. Minocycline-ethylenediaminetetraacetate lock solution for the prevention of implantable port infections in children with cancer. Clin Infect Dis. 2003 Jan 1;36(1):116-9. doi: 10.1086/344952. Epub 2002 Dec 11.
Related trials for Bacteremia
RecruitingObservational study
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Bacteria Infection Mechanism
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
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.
Bart JA Rijnders, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alcohol-lock in people with Bacteremia, run by Erasmus Medical Center at 1 site in Netherlands.
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 1 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: finished, as of the sponsor's last update on 25 Sep 2009. 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Endoluminal catheter related bacteremia (time frame: at time of catheter removal). 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 NCT00122642, which also lists 16 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 25 Sep 2009.