Intravascular-catheter ColonizationPhase 4CLEAN3NCT03757143
Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol, Combined or Not With Use of a Bundle of New Devices, for Prevention of Intravascular-catheter Colonization and Catheter Failure
A Phase 4 study testing Povidone-Iodine-Alcohol, Chlorhexidine-Alcohol and Insyte Autoguard BC Winged in people with Intravascular-catheter Colonization and Catheter Failure, run by Poitiers University Hospital at 1 site in France.
Trial summary
Short peripheral intravenous catheters (PVC) are the most frequently used invasive medical devices in hospitals. Unfortunately, PVCs often fail before the end of treatment due to the occurrence of complications, which can be mechanical, vascular or infectious. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravascular-catheter Colonization, Catheter Failure
- What is being tested?
- Povidone-Iodine-Alcohol, Chlorhexidine-Alcohol and Insyte Autoguard BC Winged
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2019to 27 Sep 2019
- 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
- Adult (age ≥ 18 years) patients,
- Having clinical indication for placement of a single PVC for at least 48 hours (no minimum port access during the study duration),
- Willing and able to provide informed consent.
Who cannot join
- Known allergies to CHG, PVI, isopropanol or ethanol,
- Participation to another clinical trial aimed at reducing PVC complications,
- Suspicion of bloodstream infection at catheter insertion,
- Skin injury a catheter insertion site increasing the risk of catheter infection,
- PVC inserted extremely urgently, making it impossible to comply with the protocol,
- Intravascular catheter in place within the last 2 days, or within the last 2 weeks and with local signs of catheter complication,
Show all 13Show fewer
- Difficult catheter insertion suspected (obesity, known IV drug users, non-visible venous network after placement of a tourniquet...),
- Patients already enrolled in this study,
- Terminal or moribund patient not expected to live more than one week,
- Patients not benefiting from a Social Security scheme or not benefiting from it through a third party,
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
- Pregnant or breastfeeding women
- Women at age to procreate and not using effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skin Antisepsis With Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol, Combined or Not With Use of a Bundle of New Devices, for Prevention of Intravascular-catheter Colonization and Catheter Failure: An Open Label, Single Center, Randomized Controlled, Two-by-two Factorial Trial
Short peripheral intravenous catheters (PVC) are the most frequently used invasive medical devices in hospitals. Unfortunately, PVCs often fail before the end of treatment due to the occurrence of complications, which can be mechanical, vascular or infectious. Complications lead to infusion failure and device replacement, which results in interrupted therapy, pain associated with resiting and increased health care costs for resources and staff time. Catheter related bloodstream infections (CR-BSIs) prolong hospitalization and increase treatment costs and mortality.
Prevention of these complications is based on the respect of hygiene rules and the use of bio-compatible catheters. The choice of the antiseptic solution for skin disinfection is key. Similarly, the use of new technologies such as catheters designed to minimize blood exposure, zero-reflux needleless-connectors, disinfecting caps, and flushing PVCs before and after each medication administration to maintain catheter patency are of theoretical interest, but little scientific data support their use in routine.
Read more
The primary objectives of this study are, first, to demonstrate that skin preparation with 2% chlorhexidine (CHG)-70% isopropanol decreases the risk of PVC colonization compared to skin preparation with 5% povidone iodine (PVI)-69% ethanol. Second, to demonstrate that use of a bundle of technologies including a new PVC, zero-reflux needless-connectors, disinfecting caps, and single-use prefilled flush syringes extends the time between catheter insertion and catheter failure.
The secondary objectives are to compare between the four study group incidence of phlebitis, accidental catheter removal, infiltration, catheter occlusion, CR-BSI, local infection, all-cause bloodstream infections, catheter colonization, duration of catheter remaining in place without complication, length of hospital stay, safety and patient satisfaction.
The CLEAN 3 study is an open-label, single centre, investigator-initiated, randomised, four-parallel group, two-by-two factorial trial. Patients requiring PVC for an expected 48 h will be randomised in one of four groups according to skin disinfection method and type of devices used. Randomization will be carried out through a secure web-based randomization system. Inclusions are expected to begin in January 2019 and continue until July 2019, once the number of catheters required has been reached.
Patients will be enrolled at the Emergency department of the Poitiers University Hospital before being hospitalised in one of five wards (neurology, neurology, pneumology, internal medicine and downstream emergency unit).
- Being tested
- Povidone-Iodine-Alcohol, Chlorhexidine-Alcohol, Insyte Autoguard BC Winged, Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringes
- Keywords
- Skin antisepsis, Chlorhexidine, Povidone Iodine, Intravascular-catheter colonization, Catheter failure, Bundle of new devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-Iodine-AlcoholDrug
Povidone-Iodine-Alcohol will be used to disinfect the skin
Chlorhexidine-AlcoholDrug
Chlorhexidine-Alcohol will be used to disinfect the skin
Insyte Autoguard BC WingedDevice
Pose of Insyte Autoguard BC Winged
Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringesDevice
Pose of Nexiva single port catheter
| Study group | Role | What they receive |
|---|---|---|
| PVI et Insyte | Active comparator | Groupe A: (1) 5% (w/v) PVI-69% (v/v) ethanol (Bétadine alcoolique™, MEDA Pharma SAS); (2) InsyteTM AutoguardTM BC Winged, BD Receives: Drug: Povidone-Iodine-Alcohol; Device: Insyte Autoguard BC Winged |
| CHG et Insyte | Experimental | Groupe B: (1) 2% (w/v) CHG-70% (v/v) isopropanol (ChloraPrep™, CareFusion); (2) InsyteTM AutoguardTM BC Winged, BD Receives: Drug: Chlorhexidine-Alcohol; Device: Insyte Autoguard BC Winged |
| PVI et Nexiva | Experimental | Groupe C: (1) 5% (w/v) PVI-69% (v/v) ethanol (Bétadine alcoolique™, MEDA Pharma SAS); (2) NexivaTM single port catheter, MaxZeroTM needleless connector, , PureHub™ Desinfecting Caps, PosiflushTM prefilled saline syringes, all from BD Receives: Drug: Povidone-Iodine-Alcohol; Device: Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringes |
| CHG et Nexiva | Experimental | Groupe D: (1) 2% (w/v) CHG-70% (v/v) isopropanol (ChloraPrep™, CareFusion); (2) NexivaTM single port catheter, MaxZeroTM needleless connector, PureHub™ Desinfecting Caps, PosiflushTM prefilled saline syringes, all from BD Receives: Drug: Chlorhexidine-Alcohol; Device: Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter-related infectious complications
Incidence of catheter-related infectious complications, and include catheter colonisation, local infection and CR-BSI
Measured: 8 days
Time between catheter insertion and catheter failure
Time between catheter insertion and catheter failure: defined as any premature removal of PVC before end of treatment, other than for routine replacement, and includes phlebitis, infiltration, occlusion, accidental catheter removal, local infection and CR-BSI whichever occurred first
Measured: 8 days
Secondary outcomes (15)
Number of phlebitis
Number of phlebitis defined as two or more of the following present simultaneously: (1) patient-reported pain or tenderness (on questioning, then palpation by the research nurse) with a severity of two or more on a ten-point scale; (2) erythema extending at least 1 cm from the insertion site; (3) swelling, extending at least 1 cm from the insertion site; (4) purulent discharge; or (5) palpable venous cord beyond the intravenous catheter tip
Measured: 8 days
Number of accidental catheter removal
Measured: 8 days
Number of infiltration
Number of infiltration, defined as the infusion of non-blistering drug leaking through the normal vascular channel and resulting in the swelling of tissue peripheral to the puncture site
Measured: 8 days
Number of catheter occlusion
Number of catheter occlusion defined as the inability of the catheter to flush (not able to intravenously inject 1ml of normal saline within 30 s)
Measured: 8 days
Number of CR-BSI
Number of CR-BSI, defined as (1) at least one positive blood culture from a peripheral vein and (2) clinical signs of infection (ie, fever [body temperature >38°5], hypothermia [body temperature <36°5], chills, or hypotension [Systolic blood pressure <90 mm Hg]) and (3) no other apparent source for the bloodstream infection except the PVC (in situ within 48 h of the bloodstream infection); and (4) a colonized intravenous catheter tip culture with the same organism (same species) as identified in the blood. For commensal micro-organisms (coagulase-negative staphylococci, Corynebacterium spp. [except C. jeikeium], Lactobacillus spp., Bacillus spp. and Propionibacterium spp., or viridans group Streptococcus isolates and C. perfringens) at least two positive blood cultures will be required.
Measured: 8 days
Number of local infection
Number of local infection, defined as organisms grown from purulent discharge with no evidence of associated bloodstream infection
Measured: 8 days
Number of all-cause bloodstream infections
Number of all-cause bloodstream infections, defined as any positive blood culture drawn from a peripheral vein while intravenous catheter in situ or for 48 h after removal. For commensal micro-organisms (coagulase-negative staphylococci, Corynebacterium spp. [except C. jeikeium], Lactobacillus spp., Bacillus spp. and Propionibacterium spp., or viridans group Streptococcus isolates and C. perfringens) at least two positive blood cultures will be required
Measured: 8 days
Number of catheter colonization
Number of catheter colonization defined as the culture of intravascular catheter tip showing at least 1000 colony-forming units per ml (cfu/ml).
Measured: 8 days
Number of pathogens involved in catheter colonization, local infections, CR-BSI and all-cause bloodstream infections
Measured: 8 days
Number of days the catheter remaining in place without complication
Measured: 8 days
Length of Hospital stay censored at day 28
Measured: 28 days
Incidence of local and systemic side effects possibly linked to antiseptic use
Measured: 8 days
Patient's evaluation of the pain at the insertion of the catheter using visual analogue scale (VAS)
Visual analogue scale is increased from 0 to 10, 0 is the better outcome (no pain) and 10 is the worse outcome
Measured: 8 days
Patient's satisfaction at catheter removal using visual analogue scale (VAS)
Visual analogue scale is increased from 0 to 10, 0 is the worse outcome (no satisfaction) and 10 is the better outcome
Measured: 8 days
Evaluation impact of venous line on patients' mobility at catheter removal using visual analogue scale
Visual analogue scale is increased from 0 to 10, 0 is the better outcome (no impact of patients'mobility) and 10 is the worse outcome
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start7 Jan 2019
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intravascular-catheter ColonizationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757143
- Sponsor's protocol ID
- CLEAN3
- Acronym
- CLEAN3
- Status last verified
- Oct 2019
- First submitted
- 27 Nov 2018
- Last updated
- 31 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maunoury F, Drugeon B, Boisson M, Marjanovic N, Couvreur R, Mimoz O, Guenezan J; CLEAN-3 Study. Cost-effectiveness analysis of bundled innovative devices versus standard approach in the prevention of unscheduled peripheral venous catheters removal due to complications in France. PLoS One. 2022 Jun 14;17(6):e0269750. doi: 10.1371/journal.pone.0269750. eCollection 2022.
PubMed 35700207Guenezan J, Marjanovic N, Drugeon B, Neill RO, Liuu E, Roblot F, Palazzo P, Bironneau V, Prevost F, Paul J, Pichon M, Boisson M, Frasca D, Mimoz O; CLEAN-3 trial investigators. Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices, for prevention of short-term peripheral venous catheter infection and failure (CLEAN 3 study): an investigator-initiated, open-label, single centre, randomised-controlled, two-by-two factorial trial. Lancet Infect Dis. 2021 Jul;21(7):1038-1048. doi: 10.1016/S1473-3099(20)30738-6. Epub 2021 Feb 1.
PubMed 33539734Guenezan J, Drugeon B, O'Neill R, Caillaud D, Senamaud C, Pouzet C, Seguin S, Frasca D, Mimoz O. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, combined or not with use of a bundle of new devices, for prevention of short-term peripheral venous catheter-related infectious complications and catheter failure: an open-label, single-centre, randomised, four-parallel group, two-by-two factorial trial: CLEAN 3 protocol study. BMJ Open. 2019 Apr 2;9(4):e028549. doi: 10.1136/bmjopen-2018-028549.
PubMed 30944142
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Antisepsis With Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol, Combined or Not With Use of a Bundle of New Devices, for Prevention of Intravascular-catheter Colonization and Catheter Failure: An Open Label, Single Center, Randomized Controlled, Two-by-two Factorial Trial
- ClinicalTrials.gov ID
- NCT03757143
- Acronym / sponsor ID
- CLEAN3 / CLEAN3
- Keywords
- Skin antisepsis, Chlorhexidine, Povidone Iodine, Intravascular-catheter colonization, Catheter failure, Bundle of new devices
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 28 Nov 2018 (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.
Short peripheral intravenous catheters (PVC) are the most frequently used invasive medical devices in hospitals. Unfortunately, PVCs often fail before the end of treatment due to the occurrence of complications, which can be mechanical, vascular or infectious. Complications lead to infusion failure and device replacement, which results in interrupted therapy, pain associated with resiting and increased health care costs for resources and staff time. Catheter related bloodstream infections (CR-BSIs) prolong hospitalization and increase treatment costs and mortality.
Prevention of these complications is based on the respect of hygiene rules and the use of bio-compatible catheters. The choice of the antiseptic solution for skin disinfection is key. Similarly, the use of new technologies such as catheters designed to minimize blood exposure, zero-reflux needleless-connectors, disinfecting caps, and flushing PVCs before and after each medication administration to maintain catheter patency are of theoretical interest, but little scientific data support their use in routine.
The primary objectives of this study are, first, to demonstrate that skin preparation with 2% chlorhexidine (CHG)-70% isopropanol decreases the risk of PVC colonization compared to skin preparation with 5% povidone iodine (PVI)-69% ethanol. Second, to demonstrate that use of a bundle of technologies including a new PVC, zero-reflux needless-connectors, disinfecting caps, and single-use prefilled flush syringes extends the time between catheter insertion and catheter failure.
The secondary objectives are to compare between the four study group incidence of phlebitis, accidental catheter removal, infiltration, catheter occlusion, CR-BSI, local infection, all-cause bloodstream infections, catheter colonization, duration of catheter remaining in place without complication, length of hospital stay, safety and patient satisfaction.
The CLEAN 3 study is an open-label, single centre, investigator-initiated, randomised, four-parallel group, two-by-two factorial trial. Patients requiring PVC for an expected 48 h will be randomised in one of four groups according to skin disinfection method and type of devices used. Randomization will be carried out through a secure web-based randomization system. Inclusions are expected to begin in January 2019 and continue until July 2019, once the number of catheters required has been reached.
Patients will be enrolled at the Emergency department of the Poitiers University Hospital before being hospitalised in one of five wards (neurology, neurology, pneumology, internal medicine and downstream emergency unit).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PVI et Insyte | Active comparator | Drug: Povidone-Iodine-Alcohol, Device: Insyte Autoguard BC WingedGroupe A: (1) 5% (w/v) PVI-69% (v/v) ethanol (Bétadine alcoolique™, MEDA Pharma SAS); (2) InsyteTM AutoguardTM BC Winged, BD |
| CHG et Insyte | Experimental | Drug: Chlorhexidine-Alcohol, Device: Insyte Autoguard BC WingedGroupe B: (1) 2% (w/v) CHG-70% (v/v) isopropanol (ChloraPrep™, CareFusion); (2) InsyteTM AutoguardTM BC Winged, BD |
| PVI et Nexiva | Experimental | Drug: Povidone-Iodine-Alcohol, Device: Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringesGroupe C: (1) 5% (w/v) PVI-69% (v/v) ethanol (Bétadine alcoolique™, MEDA Pharma SAS); (2) NexivaTM single port catheter, MaxZeroTM needleless connector, , PureHub™ Desinfecting Caps, PosiflushTM prefilled saline syringes, all from BD |
| CHG et Nexiva | Experimental | Drug: Chlorhexidine-Alcohol, Device: Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringesGroupe D: (1) 2% (w/v) CHG-70% (v/v) isopropanol (ChloraPrep™, CareFusion); (2) NexivaTM single port catheter, MaxZeroTM needleless connector, PureHub™ Desinfecting Caps, PosiflushTM prefilled saline syringes, all from BD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (age ≥ 18 years) patients,
- Having clinical indication for placement of a single PVC for at least 48 hours (no minimum port access during the study duration),
- Willing and able to provide informed consent.
Key exclusion criteria (13 listed)
- Known allergies to CHG, PVI, isopropanol or ethanol,
- Participation to another clinical trial aimed at reducing PVC complications,
- Suspicion of bloodstream infection at catheter insertion,
- Skin injury a catheter insertion site increasing the risk of catheter infection,
- PVC inserted extremely urgently, making it impossible to comply with the protocol,
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 |
|---|---|---|
| Povidone-Iodine-AlcoholPovidone-Iodine-Alcohol will be used to disinfect the skin | Drug | PVI et Insyte, PVI et Nexiva |
| Chlorhexidine-AlcoholChlorhexidine-Alcohol will be used to disinfect the skin | Drug | CHG et Insyte, CHG et Nexiva |
| Insyte Autoguard BC WingedPose of Insyte Autoguard BC Winged | Device | CHG et Insyte, PVI et Insyte |
| Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringesPose of Nexiva single port catheter | Device | CHG et Nexiva, PVI et Nexiva |
Primary outcome
Incidence of catheter-related infectious complications
Time frame: 8 days
Incidence of catheter-related infectious complications, and include catheter colonisation, local infection and CR-BSI
Time between catheter insertion and catheter failure
Time frame: 8 days
Time between catheter insertion and catheter failure: defined as any premature removal of PVC before end of treatment, other than for routine replacement, and includes phlebitis, infiltration, occlusion, accidental catheter removal, local infection and CR-BSI whichever occurred first
15 secondary outcomes
Number of phlebitis
Time frame: 8 days
Number of accidental catheter removal
Time frame: 8 days
Number of infiltration
Time frame: 8 days
Number of catheter occlusion
Time frame: 8 days
Number of CR-BSI
Time frame: 8 days
Number of local infection
Time frame: 8 days
Number of all-cause bloodstream infections
Time frame: 8 days
Number of catheter colonization
Time frame: 8 days
Number of pathogens involved in catheter colonization, local infections, CR-BSI and all-cause bloodstream infections
Time frame: 8 days
Number of days the catheter remaining in place without complication
Time frame: 8 days
Length of Hospital stay censored at day 28
Time frame: 28 days
Incidence of local and systemic side effects possibly linked to antiseptic use
Time frame: 8 days
Patient's evaluation of the pain at the insertion of the catheter using visual analogue scale (VAS)
Time frame: 8 days
Patient's satisfaction at catheter removal using visual analogue scale (VAS)
Time frame: 8 days
Evaluation impact of venous line on patients' mobility at catheter removal using visual analogue scale
Time frame: 8 days
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 31 Oct 2019.
- Derived from this study: PubMed 35700207Maunoury F, Drugeon B, Boisson M, Marjanovic N, Couvreur R, Mimoz O, Guenezan J; CLEAN-3 Study. Cost-effectiveness analysis of bundled innovative devices versus standard approach in the prevention of unscheduled peripheral venous catheters removal due to complications in France. PLoS One. 2022 Jun 14;17(6):e0269750. doi: 10.1371/journal.pone.0269750. eCollection 2022.
- Derived from this study: PubMed 33539734Guenezan J, Marjanovic N, Drugeon B, Neill RO, Liuu E, Roblot F, Palazzo P, Bironneau V, Prevost F, Paul J, Pichon M, Boisson M, Frasca D, Mimoz O; CLEAN-3 trial investigators. Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices, for prevention of short-term peripheral venous catheter infection and failure (CLEAN 3 study): an investigator-initiated, open-label, single centre, randomised-controlled, two-by-two factorial trial. Lancet Infect Dis. 2021 Jul;21(7):1038-1048. doi: 10.1016/S1473-3099(20)30738-6. Epub 2021 Feb 1.
- Derived from this study: PubMed 30944142Guenezan J, Drugeon B, O'Neill R, Caillaud D, Senamaud C, Pouzet C, Seguin S, Frasca D, Mimoz O. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, combined or not with use of a bundle of new devices, for prevention of short-term peripheral venous catheter-related infectious complications and catheter failure: an open-label, single-centre, randomised, four-parallel group, two-by-two factorial trial: CLEAN 3 protocol study. BMJ Open. 2019 Apr 2;9(4):e028549. doi: 10.1136/bmjopen-2018-028549.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Povidone-Iodine-Alcohol, Chlorhexidine-Alcohol and Insyte Autoguard BC Winged in people with Intravascular-catheter Colonization and Catheter Failure, run by Poitiers University Hospital at 1 site in France.
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 13 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 31 Oct 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 France. 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?
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?
Incidence of catheter-related infectious complications (time frame: 8 days). The study lists 2 primary outcomes in all. 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 NCT03757143, which also lists 3 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 31 Oct 2019.