Infection, Catheter-RelatedPhase 3E-LockPedNCT03253887
Ethanol-lock Therapy for the Prevention of Non-tunneled Catheter-related Infection in Pediatric Patients
A Phase 3 study testing Ethanol-lock in people with Infection, Catheter-Related and Central Line-associated Bloodstream Infection (CLABSI), run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
Central venous catheter (CVC) infection is a common complication in pediatric patients, resulting in prolonged length of stay in hospital, requiring antibiotics, invasive procedures and increase morbidity and mortality. Given the repercussion of this complication, measures that minimize its should be stimulated. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Infection, Catheter-Related, Central Line-associated Bloodstream Infection (CLABSI), Pediatric
- What is being tested?
- Ethanol-lock
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Apr 2017
- Phase
- Phase 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric surgery patients;
- Weight: 2 Kg or more;
- Using non-tunneled double-lumen polyurethane central venous catheter;
- CVC inserted at operation room, Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU);
- CVC adequately positioned (checked by radioscopy ou radiography);
- CVC implanted within a maximum of 24 hours.
Who cannot join
- Patients whose catheters had been inserted under emergency situations;
- Patients in a critical condition (those requiring continuous fluid/drug infusion through both lumens);
- Patients with a history of hypersensitivity or allergic reactions to ethanol were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Integral Prof Fernando Figueira
Recife, Pernambuco, 50070-550
About this study
Official title: Effectiveness of Ethanol-Lock Therapy for the Prevention of Non-Tunneled Catheter-Related Bloodstream Infection in Pediatric Patients: A Randomised Controlled Trial
Central venous catheter (CVC) infection is a common complication in pediatric patients, resulting in prolonged length of stay in hospital, requiring antibiotics, invasive procedures and increase morbidity and mortality. Given the repercussion of this complication, measures that minimize its should be stimulated. The purpose of this study is to evaluate the effects of intraluminal alcoholization (ethanol lock therapy) on prevention of infection of short-term central venous catheters in pediatric patients.
Read the detailed description
The patients was divided into two groups, where one received alcoholization (ethanol lock therapy group) and the other not (control group). The variables evaluated were: CLABSI, etiological agents, adverse events and the mechanical effects of ethanol on the catheter (breakage and obstruction). To determine the association between the independent variable and the dependent variables, the chi-square test of association (Pearson) and Fisher's exact test were used. The Risk Ratio (RR) was calculated as a relative risk measure, with its 95% confidence interval (95% CI). The significance level of 5% was adopted. The sample size calculation was performed in the OpenEpi software version 2.3.1. And a long-term catheter clinical trial was used to calculate the sample size, which demonstrated a 9% central venous catheter infection frequency in the ethanol group and 37% in the control group, so that the sample size was 80 patients (40 in each group), considering a power of 80%, an alpha error of 5% and 10% of post-randomization losses.
- Conditions
- Infection, Catheter-Related, Central Line-associated Bloodstream Infection (CLABSI), Pediatric
- Being tested
- Ethanol-lock
- Keywords
- Central Venous Catheters, Child, ethanol therapy, CLABSI
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol-lockDrug
Also called Ethanol 70%, Alcohol 70%
This group received daily alcohol 70% (ethanol-lock) received intraluminal ethanol at a volume sufficient to fill the catheter lumen, ranged from 0.1 to 0.3 ml, with the volume being previously established. ELT was maintained for two full hours in each catheter lumen, with the lumen remaining locked during this period. The same procedure was then carried out with the other lumen. Prior to and following ELT, flushing was performed using 5-10 ml of 0.9% saline solution.
| Study group | Role | What they receive |
|---|---|---|
| Ethanol-lock therapy (ELT) Group | Experimental | This group received daily alcohol 70% (ethanol-lock) with intraluminal alcoholization of both lumens of the central venous catheters Receives: Drug: Ethanol-lock |
| Control Group | No intervention | This group did not receive the ethanol-lock, being only followed daily and treated according to the standard protocol in operation at this healthcare unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them
Measure of Central line associated bloodstream infection (CLABSI) rate per 1000 catheter-days compared between the groups, according to CDC's National Healthcare Safety Network (CDC/NHSN) 2015 definitions.
Measured: Period from 48 hours after catheter insertion to 24 hours after catheter removal
Secondary outcomes (3)
main etiological agents involved in central line associated bloodstream infection (CLABSI) events
The organisms responsable for each CLABSI event: gram negatives, gram positives or fungus. Identified by one or more blood specimens by a culture or non-culture based microbiologic testing method and the organism(s) identified in blood is not related to an infection at another site
Measured: Considering that blood specimens were collected 48 hours after catheter insertion and up to 24 hours after catheter removal, from July 2016 to April 2017.
Incidence of Treatment-Emergent Adverse Events
Number of episodes of adverse events (dizziness, headache, dyspnea, chest pain, alcohol taste, facial flushing, nausea, vomiting, pruritus, sneezing, slurred speech, irritability)
Measured: During the use of ethanol-lock therapy
Incidence of mechanical effects of ethanol-lock on the catheter (catheter breakage and obstruction)
Evaluate mechanical effects of ethanol-lock on the catheter, by the number of participants with catheter breakage or catheter obstruction in each group
Measured: During the use of ethanol-lock therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study startMar 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Infection, Catheter-RelatedStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It's a randomized controlled clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Collaborators
- Bellisa Caldas Lopes, Thuanne Beatriz Silva Tenório, Rodrigo Melo Gallindo, Paulo Sérgio Gomes Nogueira Borges, Lara Barreto Machado
- Responsible party
- Principal investigator, Flavia orange, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- Bellisa C Lopes, Master, Principal investigator, Instituto de Medicina Integral Prof Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253887
- Sponsor's protocol ID
- 55008116.8.0000.5201
- Acronym
- E-LockPed
- Status last verified
- Oct 2019
- First submitted
- 28 Mar 2017
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flynn PM. Diagnosis and management of central venous catheter-related bloodstream infections in pediatric patients. Pediatr Infect Dis J. 2009 Nov;28(11):1016-7. doi: 10.1097/INF.0b013e3181bf7bfc. No abstract available.
PubMed 19859018Ullman AJ, Cooke ML, Mitchell M, Lin F, New K, Long DA, Mihala G, Rickard CM. Dressings and securement devices for central venous catheters (CVC). Cochrane Database Syst Rev. 2015 Sep 10;2015(9):CD010367. doi: 10.1002/14651858.CD010367.pub2.
PubMed 26358142Rosado V, Romanelli RM, Camargos PA. Risk factors and preventive measures for catheter-related bloodstream infections. J Pediatr (Rio J). 2011 Nov-Dec;87(6):469-77. doi: 10.2223/JPED.2134.
PubMed 22170387Subha Rao SD, Joseph MP, Lavi R, Macaden R. Infections related to vascular catheters in a pediatric intensive care unit. Indian Pediatr. 2005 Jul;42(7):667-72.
PubMed 16085967Cruzeiro PC, Camargos PA, Miranda ME. Central venous catheter placement in children: a prospective study of complications in a Brazilian public hospital. Pediatr Surg Int. 2006 Jun;22(6):536-40. doi: 10.1007/s00383-006-1671-2. Epub 2006 May 5.
PubMed 16736225Huang EY, Chen C, Abdullah F, Aspelund G, Barnhart DC, Calkins CM, Cowles RA, Downard CD, Goldin AB, Lee SL, St Peter SD, Arca MJ; 2011 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Strategies for the prevention of central venous catheter infections: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2011 Oct;46(10):2000-11. doi: 10.1016/j.jpedsurg.2011.06.017.
PubMed 22008341Webster J, Gillies D, O'Riordan E, Sherriff KL, Rickard CM. WITHDRAWN: Gauze and tape and transparent polyurethane dressings for central venous catheters. Cochrane Database Syst Rev. 2016 May 4;2016(5):CD003827. doi: 10.1002/14651858.CD003827.pub3.
PubMed 27144903Costello JM, Morrow DF, Graham DA, Potter-Bynoe G, Sandora TJ, Laussen PC. Systematic intervention to reduce central line-associated bloodstream infection rates in a pediatric cardiac intensive care unit. Pediatrics. 2008 May;121(5):915-23. doi: 10.1542/peds.2007-1577.
PubMed 18450894Wolf J, Shenep JL, Clifford V, Curtis N, Flynn PM. Ethanol lock therapy in pediatric hematology and oncology. Pediatr Blood Cancer. 2013 Jan;60(1):18-25. doi: 10.1002/pbc.24249. Epub 2012 Aug 21.
PubMed 22911535Shenep LE, Shenep MA, Cheatham W, Hoffman JM, Hale A, Williams BF, Perkins R, Hewitt CB, Hayden RT, Shenep JL. Efficacy of intravascular catheter lock solutions containing preservatives in the prevention of microbial colonization. J Hosp Infect. 2011 Dec;79(4):317-22. doi: 10.1016/j.jhin.2011.07.010. Epub 2011 Sep 25.
PubMed 21945067Wales PW, Kosar C, Carricato M, de Silva N, Lang K, Avitzur Y. Ethanol lock therapy to reduce the incidence of catheter-related bloodstream infections in home parenteral nutrition patients with intestinal failure: preliminary experience. J Pediatr Surg. 2011 May;46(5):951-6. doi: 10.1016/j.jpedsurg.2011.02.036.
PubMed 21616259Sanders J, Pithie A, Ganly P, Surgenor L, Wilson R, Merriman E, Loudon G, Judkins R, Chambers S. A prospective double-blind randomized trial comparing intraluminal ethanol with heparinized saline for the prevention of catheter-associated bloodstream infection in immunosuppressed haematology patients. J Antimicrob Chemother. 2008 Oct;62(4):809-15. doi: 10.1093/jac/dkn284. Epub 2008 Jul 11.
PubMed 18621987Chambers ST, Peddie B, Pithie A. Ethanol disinfection of plastic-adherent micro-organisms. J Hosp Infect. 2006 Jun;63(2):193-6. doi: 10.1016/j.jhin.2006.01.009. Epub 2006 Apr 4.
PubMed 16600429Abu-El-Haija M, Schultz J, Rahhal RM. Effects of 70% ethanol locks on rates of central line infection, thrombosis, breakage, and replacement in pediatric intestinal failure. J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):703-8. doi: 10.1097/MPG.0000000000000354.
PubMed 24590214Crnich CJ, Halfmann JA, Crone WC, Maki DG. The effects of prolonged ethanol exposure on the mechanical properties of polyurethane and silicone catheters used for intravascular access. Infect Control Hosp Epidemiol. 2005 Aug;26(8):708-14. doi: 10.1086/502607.
PubMed 16156328
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ethanol-Lock Therapy for the Prevention of Non-Tunneled Catheter-Related Bloodstream Infection in Pediatric Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03253887
- Acronym / sponsor ID
- E-LockPed / 55008116.8.0000.5201
- Conditions
- Infection, Catheter-Related, Central Line-associated Bloodstream Infection (CLABSI), Pediatric
- Keywords
- Central Venous Catheters, Child, ethanol therapy, CLABSI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Collaborators
- Bellisa Caldas Lopes, Thuanne Beatriz Silva Tenório, Rodrigo Melo Gallindo, Paulo Sérgio Gomes Nogueira Borges, Lara Barreto Machado
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 Aug 2017 (actual)
- 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.
Central venous catheter (CVC) infection is a common complication in pediatric patients, resulting in prolonged length of stay in hospital, requiring antibiotics, invasive procedures and increase morbidity and mortality. Given the repercussion of this complication, measures that minimize its should be stimulated. The purpose of this study is to evaluate the effects of intraluminal alcoholization (ethanol lock therapy) on prevention of infection of short-term central venous catheters in pediatric patients.
Detailed description
The patients was divided into two groups, where one received alcoholization (ethanol lock therapy group) and the other not (control group). The variables evaluated were: CLABSI, etiological agents, adverse events and the mechanical effects of ethanol on the catheter (breakage and obstruction). To determine the association between the independent variable and the dependent variables, the chi-square test of association (Pearson) and Fisher's exact test were used. The Risk Ratio (RR) was calculated as a relative risk measure, with its 95% confidence interval (95% CI). The significance level of 5% was adopted. The sample size calculation was performed in the OpenEpi software version 2.3.1. And a long-term catheter clinical trial was used to calculate the sample size, which demonstrated a 9% central venous catheter infection frequency in the ethanol group and 37% in the control group, so that the sample size was 80 patients (40 in each group), considering a power of 80%, an alpha error of 5% and 10% of post-randomization losses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It's a randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Ethanol-lock therapy (ELT) Group | Experimental | Drug: Ethanol-lockThis group received daily alcohol 70% (ethanol-lock) with intraluminal alcoholization of both lumens of the central venous catheters |
| Control Group | No intervention | –This group did not receive the ethanol-lock, being only followed daily and treated according to the standard protocol in operation at this healthcare unit. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Pediatric surgery patients;
- Weight: 2 Kg or more;
- Using non-tunneled double-lumen polyurethane central venous catheter;
- CVC inserted at operation room, Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU);
- CVC adequately positioned (checked by radioscopy ou radiography);
Key exclusion criteria (3 listed)
- Patients whose catheters had been inserted under emergency situations;
- Patients in a critical condition (those requiring continuous fluid/drug infusion through both lumens);
- Patients with a history of hypersensitivity or allergic reactions to ethanol were excluded from the study.
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 |
|---|---|---|
| Ethanol-lockAlso: Ethanol 70%, Alcohol 70%This group received daily alcohol 70% (ethanol-lock) received intraluminal ethanol at a volume sufficient to fill the catheter lumen, ranged from 0.1 to 0.3 ml, with the volume being previously established. ELT was maintained for two full hours in each catheter lumen, with the lumen remaining locked during this period. The same procedure was then carried out with the other lumen. Prior to and following ELT, flushing was performed using 5-10 ml of 0.9% saline solution. | Drug | Ethanol-lock therapy (ELT) Group |
Primary outcome
Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them
Time frame: Period from 48 hours after catheter insertion to 24 hours after catheter removal
Measure of Central line associated bloodstream infection (CLABSI) rate per 1000 catheter-days compared between the groups, according to CDC's National Healthcare Safety Network (CDC/NHSN) 2015 definitions.
3 secondary outcomes
main etiological agents involved in central line associated bloodstream infection (CLABSI) events
Time frame: Considering that blood specimens were collected 48 hours after catheter insertion and up to 24 hours after catheter removal, from July 2016 to April 2017.
Incidence of Treatment-Emergent Adverse Events
Time frame: During the use of ethanol-lock therapy
Incidence of mechanical effects of ethanol-lock on the catheter (catheter breakage and obstruction)
Time frame: During the use of ethanol-lock therapy
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 1 Nov 2019.
- Background: PubMed 19859018Flynn PM. Diagnosis and management of central venous catheter-related bloodstream infections in pediatric patients. Pediatr Infect Dis J. 2009 Nov;28(11):1016-7. doi: 10.1097/INF.0b013e3181bf7bfc. No abstract available.
- Background: PubMed 26358142Ullman AJ, Cooke ML, Mitchell M, Lin F, New K, Long DA, Mihala G, Rickard CM. Dressings and securement devices for central venous catheters (CVC). Cochrane Database Syst Rev. 2015 Sep 10;2015(9):CD010367. doi: 10.1002/14651858.CD010367.pub2.
- Background: PubMed 22170387Rosado V, Romanelli RM, Camargos PA. Risk factors and preventive measures for catheter-related bloodstream infections. J Pediatr (Rio J). 2011 Nov-Dec;87(6):469-77. doi: 10.2223/JPED.2134.
- Background: PubMed 16085967Subha Rao SD, Joseph MP, Lavi R, Macaden R. Infections related to vascular catheters in a pediatric intensive care unit. Indian Pediatr. 2005 Jul;42(7):667-72.
- Background: PubMed 16736225Cruzeiro PC, Camargos PA, Miranda ME. Central venous catheter placement in children: a prospective study of complications in a Brazilian public hospital. Pediatr Surg Int. 2006 Jun;22(6):536-40. doi: 10.1007/s00383-006-1671-2. Epub 2006 May 5.
- Background: PubMed 22008341Huang EY, Chen C, Abdullah F, Aspelund G, Barnhart DC, Calkins CM, Cowles RA, Downard CD, Goldin AB, Lee SL, St Peter SD, Arca MJ; 2011 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Strategies for the prevention of central venous catheter infections: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2011 Oct;46(10):2000-11. doi: 10.1016/j.jpedsurg.2011.06.017.
- Background: PubMed 27144903Webster J, Gillies D, O'Riordan E, Sherriff KL, Rickard CM. WITHDRAWN: Gauze and tape and transparent polyurethane dressings for central venous catheters. Cochrane Database Syst Rev. 2016 May 4;2016(5):CD003827. doi: 10.1002/14651858.CD003827.pub3.
- Background: PubMed 18450894Costello JM, Morrow DF, Graham DA, Potter-Bynoe G, Sandora TJ, Laussen PC. Systematic intervention to reduce central line-associated bloodstream infection rates in a pediatric cardiac intensive care unit. Pediatrics. 2008 May;121(5):915-23. doi: 10.1542/peds.2007-1577.
- Background: PubMed 22911535Wolf J, Shenep JL, Clifford V, Curtis N, Flynn PM. Ethanol lock therapy in pediatric hematology and oncology. Pediatr Blood Cancer. 2013 Jan;60(1):18-25. doi: 10.1002/pbc.24249. Epub 2012 Aug 21.
- Background: PubMed 21945067Shenep LE, Shenep MA, Cheatham W, Hoffman JM, Hale A, Williams BF, Perkins R, Hewitt CB, Hayden RT, Shenep JL. Efficacy of intravascular catheter lock solutions containing preservatives in the prevention of microbial colonization. J Hosp Infect. 2011 Dec;79(4):317-22. doi: 10.1016/j.jhin.2011.07.010. Epub 2011 Sep 25.
- Background: PubMed 21616259Wales PW, Kosar C, Carricato M, de Silva N, Lang K, Avitzur Y. Ethanol lock therapy to reduce the incidence of catheter-related bloodstream infections in home parenteral nutrition patients with intestinal failure: preliminary experience. J Pediatr Surg. 2011 May;46(5):951-6. doi: 10.1016/j.jpedsurg.2011.02.036.
- Background: PubMed 18621987Sanders J, Pithie A, Ganly P, Surgenor L, Wilson R, Merriman E, Loudon G, Judkins R, Chambers S. A prospective double-blind randomized trial comparing intraluminal ethanol with heparinized saline for the prevention of catheter-associated bloodstream infection in immunosuppressed haematology patients. J Antimicrob Chemother. 2008 Oct;62(4):809-15. doi: 10.1093/jac/dkn284. Epub 2008 Jul 11.
- Individual participant dataSharing planned: No
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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.
Bellisa C Lopes, Master principal investigator
Instituto de Medicina Integral Prof Fernando Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ethanol-lock in people with Infection, Catheter-Related and Central Line-associated Bloodstream Infection (CLABSI), run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
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 6 inclusion and 3 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 1 Nov 2019. 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 Brazil. 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 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?
Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them (time frame: Period from 48 hours after catheter insertion to 24 hours after 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 NCT03253887, which also lists 21 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 1 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.