Preventing Catheter Related InfectionPhase 4CLEANNCT01629550
Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients
A Phase 4 study testing skin disinfection prior catheter insertion in people with Preventing Catheter Related Infection, run by Poitiers University Hospital at 5 sites in France.
Trial summary
Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preventing Catheter Related Infection
- What is being tested?
- skin disinfection prior catheter insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 5 sitesFrance
- Study dates
- Oct 2012to not given
- 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
- ≥ 18 year-old
- Expected duration of ICU stay ≥ 48 hours
- Patient requiring the insertion of at least one arterial catheter and/or central venous catheter and/or catheter for hemodialysis.
Who cannot join
- Patient with history of allergy to any of the antiseptic agent studied
- Expected survival < 48 hours
- Catheter inserted outside the ICU or in emergency without respect of preventive measures.
- Use of antimicrobial impregnated catheters or antiseptic impregnated dressings.
- Pregnant woman or breast-feeding mother
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Angers University Hospital
Angers, 49933
Estain University Hospital
Clermont-Ferrand, 63000
Bichat-Claude Bernard Hospital
Paris, 75018
Lyon University Hospital
Pierre-Bénite, 69465
Poitiers University Hospital
Poitiers, 86021
About this study
Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Consequently, the quality of skin disinfection is the most effective preventive measure to reduce the incidence of these infections.
This aim of the present study is to compare four strategies of skin disinfection to determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone iodine in reducing catheter infection and to assess whether a detersion phase prior to disinfection reduces catheter colonization as compared with no detersion.
- Conditions
- Preventing Catheter Related Infection
- Being tested
- skin disinfection prior catheter insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin disinfection prior catheter insertionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PVI paint | Active comparator | 5% alcoholic povidone iodine paint Receives: Procedure: skin disinfection prior catheter insertion |
| PVI scrub and paint | Active comparator | detersion with 4% povidone iodine scrub followed by 5% alcoholic povidone iodine paint Receives: Procedure: skin disinfection prior catheter insertion |
| Chlorhexidine paint | Active comparator | 2% alcoholic chlorhexidine paint Receives: Procedure: skin disinfection prior catheter insertion |
| chlorhexidine scrub and paint | Active comparator | Detersion with 4% chlorhexidine scrub followed 2% alcoholic chlorhexidine paint Receives: Procedure: skin disinfection prior catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major catheter related infection
Secondary outcomes (7)
Catheter colonization
Catheter related bacteremia
Colonization insertion site
Prolongation hospitalization due to catheter infection
Mortality due to catheter infection
Skin allergy and anaphylactic shock
Costs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preventing Catheter Related InfectionStudies 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
- 2,400 participants
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629550
- Sponsor's protocol ID
- CLEAN
- Acronym
- CLEAN
- Status last verified
- Mar 2014
- First submitted
- 20 Jun 2012
- Last updated
- 11 Oct 2016
- Results posted
- No
Publications
Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Valette X, Daubin C, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials. Ann Intensive Care. 2023 Jan 16;13(1):5. doi: 10.1186/s13613-023-01099-9.
PubMed 36645531Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.
PubMed 35799302Buetti N, Ruckly S, Lucet JC, Bouadma L, Schwebel C, Mimoz O, Timsit JF. Ultrasound guidance and risk for intravascular catheter-related infections among peripheral arterial catheters: a post-hoc analysis of two large randomized-controlled trials. Ann Intensive Care. 2020 Jul 8;10(1):89. doi: 10.1186/s13613-020-00705-4.
PubMed 32643100Maunoury F, Farinetto C, Ruckly S, Guenezan J, Lucet JC, Lepape A, Pascal J, Souweine B, Mimoz O, Timsit JF. Cost-effectiveness analysis of chlorhexidine-alcohol versus povidone iodine-alcohol solution in the prevention of intravascular-catheter-related bloodstream infections in France. PLoS One. 2018 May 25;13(5):e0197747. doi: 10.1371/journal.pone.0197747. eCollection 2018.
PubMed 29799871Mimoz O, Lucet JC, Kerforne T, Pascal J, Souweine B, Goudet V, Mercat A, Bouadma L, Lasocki S, Alfandari S, Friggeri A, Wallet F, Allou N, Ruckly S, Balayn D, Lepape A, Timsit JF; CLEAN trial investigators. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, with and without skin scrubbing, for prevention of intravascular-catheter-related infection (CLEAN): an open-label, multicentre, randomised, controlled, two-by-two factorial trial. Lancet. 2015 Nov 21;386(10008):2069-2077. doi: 10.1016/S0140-6736(15)00244-5. Epub 2015 Sep 18.
PubMed 26388532Goudet V, Timsit JF, Lucet JC, Lepape A, Balayn D, Seguin S, Mimoz O. Comparison of four skin preparation strategies to prevent catheter-related infection in intensive care unit (CLEAN trial): a study protocol for a randomized controlled trial. Trials. 2013 Apr 27;14:114. doi: 10.1186/1745-6215-14-114.
PubMed 23782845
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Multicenter Trial of 4 Antiseptic Strategies for Prevention of Catheter Infection in Intensive Care Unit for Adults Patients
- ClinicalTrials.gov ID
- NCT01629550
- Acronym / sponsor ID
- CLEAN / CLEAN
- Conditions
- Preventing Catheter Related Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- First posted
- 27 Jun 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.
Catheter related infection is the third cause of nosocomial infection in ICUs. Most of them are avoidable and can be prevent by improving aseptic practices during catheter insertion and maintenance. Indeed, the main route of catheter contamination for short-term catheters is the insertion site. Consequently, the quality of skin disinfection is the most effective preventive measure to reduce the incidence of these infections.
This aim of the present study is to compare four strategies of skin disinfection to determine whether a 2% alcoholic solution of chlorhexidine acts better than 5% alcoholic povidone iodine in reducing catheter infection and to assess whether a detersion phase prior to disinfection reduces catheter colonization as compared with no detersion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PVI paint | Active comparator | Procedure: skin disinfection prior catheter insertion5% alcoholic povidone iodine paint |
| PVI scrub and paint | Active comparator | Procedure: skin disinfection prior catheter insertiondetersion with 4% povidone iodine scrub followed by 5% alcoholic povidone iodine paint |
| Chlorhexidine paint | Active comparator | Procedure: skin disinfection prior catheter insertion2% alcoholic chlorhexidine paint |
| chlorhexidine scrub and paint | Active comparator | Procedure: skin disinfection prior catheter insertionDetersion with 4% chlorhexidine scrub followed 2% alcoholic chlorhexidine paint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 year-old
- Expected duration of ICU stay ≥ 48 hours
- Patient requiring the insertion of at least one arterial catheter and/or central venous catheter and/or catheter for hemodialysis.
Key exclusion criteria (5 listed)
- Patient with history of allergy to any of the antiseptic agent studied
- Expected survival < 48 hours
- Catheter inserted outside the ICU or in emergency without respect of preventive measures.
- Use of antimicrobial impregnated catheters or antiseptic impregnated dressings.
- Pregnant woman or breast-feeding mother
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 |
|---|---|---|
| skin disinfection prior catheter insertion | Procedure or surgery | Chlorhexidine paint, PVI paint, PVI scrub and paint, chlorhexidine scrub and paint |
Primary outcome
Major catheter related infection
7 secondary outcomes
Catheter colonization
Catheter related bacteremia
Colonization insertion site
Prolongation hospitalization due to catheter infection
Mortality due to catheter infection
Skin allergy and anaphylactic shock
Costs
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 11 Oct 2016.
- Derived from this study: PubMed 36645531Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Valette X, Daubin C, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials. Ann Intensive Care. 2023 Jan 16;13(1):5. doi: 10.1186/s13613-023-01099-9.
- Derived from this study: PubMed 35799302Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.
- Derived from this study: PubMed 32643100Buetti N, Ruckly S, Lucet JC, Bouadma L, Schwebel C, Mimoz O, Timsit JF. Ultrasound guidance and risk for intravascular catheter-related infections among peripheral arterial catheters: a post-hoc analysis of two large randomized-controlled trials. Ann Intensive Care. 2020 Jul 8;10(1):89. doi: 10.1186/s13613-020-00705-4.
- Derived from this study: PubMed 29799871Maunoury F, Farinetto C, Ruckly S, Guenezan J, Lucet JC, Lepape A, Pascal J, Souweine B, Mimoz O, Timsit JF. Cost-effectiveness analysis of chlorhexidine-alcohol versus povidone iodine-alcohol solution in the prevention of intravascular-catheter-related bloodstream infections in France. PLoS One. 2018 May 25;13(5):e0197747. doi: 10.1371/journal.pone.0197747. eCollection 2018.
- Derived from this study: PubMed 26388532Mimoz O, Lucet JC, Kerforne T, Pascal J, Souweine B, Goudet V, Mercat A, Bouadma L, Lasocki S, Alfandari S, Friggeri A, Wallet F, Allou N, Ruckly S, Balayn D, Lepape A, Timsit JF; CLEAN trial investigators. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, with and without skin scrubbing, for prevention of intravascular-catheter-related infection (CLEAN): an open-label, multicentre, randomised, controlled, two-by-two factorial trial. Lancet. 2015 Nov 21;386(10008):2069-2077. doi: 10.1016/S0140-6736(15)00244-5. Epub 2015 Sep 18.
- Derived from this study: PubMed 23782845Goudet V, Timsit JF, Lucet JC, Lepape A, Balayn D, Seguin S, Mimoz O. Comparison of four skin preparation strategies to prevent catheter-related infection in intensive care unit (CLEAN trial): a study protocol for a randomized controlled trial. Trials. 2013 Apr 27;14:114. doi: 10.1186/1745-6215-14-114.
Related trials for Preventing Catheter Related Infection
Not yet recruitingPhase 4
Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies
Hydrocephalus, Ventriculoperitoneal Shunt Infection
RecruitingObservational study
Epidemiological Investigation of Central Venous Catheter-related Bloodstream Infections in Icus in China
CLABSI - Central Line Associated Bloodstream Infection
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing skin disinfection prior catheter insertion in people with Preventing Catheter Related Infection, run by Poitiers University Hospital at 5 sites 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 5 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 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Major catheter related infection. 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 NCT01629550, which also lists 6 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 11 Oct 2016.