ICU Patients Requiring a Central Venous AccessPhase 4NCT00259350
Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection
A Phase 4 study testing Skin disinfection in people with ICU Patients Requiring a Central Venous Access, run by Poitiers University Hospital at 1 site in France.
Trial summary
The best antiseptic solution for cateheter care remains unknown.High concentration in aquous solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone iodine in aquous solutions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patients Requiring a Central Venous Access
- What is being tested?
- Skin disinfection
- How many people
- 520 participants
- Where
- 1 siteFrance
- Study dates
- May 2004to Apr 2006
- 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
- Patients over 18 yeras of age
- Requiring an internal jugular or sub-clavian central venous catheter for their care during at least 72 h
- Informed consent signed up
Who cannot join
- Bacteriemic infection not under control
- extensive cutaneous infection
- Women with childbearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Central Venous Catheter Infections : Comparison of the Efficacy of Skin Disinfection With 5% Povidone Iodine in Alcoholic Solution Versus 0.25% Chlorhexidine, 0.025 Benzalkonium and 4% Benzylic Alcohol
The best antiseptic solution for cateheter care remains unknown.High concentration in aquous solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone iodine in aquous solutions. No study has compare alcoholic formulations of low concentration of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central venous catheters.
To compare the incidence of central venous catheter colonization after skin disinfection with either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine, 0.025% Benzalkonium and 4% benzylic alcohol.
To compare the incidence of catheter related bacteremia in the to study groups. To compare the local and general tolerance of the two antiseptic formulations
- Being tested
- Skin disinfection
- Keywords
- Central venous catheter, Skin disinfection, Antisepsis, Nosocomial infection, Catheter infection
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin disinfectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of catheter colonization
Secondary outcomes (3)
Prevention of catheter related bacteremia
Prevention of a positive culture of the catheter whaterver the threshold
Local and general tolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startMay 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ICU Patients Requiring a Central Venous AccessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Olivier MIMOZ, MD, PhD, Study chair, University Hospital of Poitiers, france
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259350
- Sponsor's protocol ID
- Anticath
- Status last verified
- Jan 2009
- First submitted
- 27 Nov 2005
- Last updated
- 27 Jan 2009
- Results posted
- No
Publications
Mimoz O, Villeminey S, Ragot S, Dahyot-Fizelier C, Laksiri L, Petitpas F, Debaene B. Chlorhexidine-based antiseptic solution vs alcohol-based povidone-iodine for central venous catheter care. Arch Intern Med. 2007 Oct 22;167(19):2066-72. doi: 10.1001/archinte.167.19.2066.
PubMed 17954800
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Central Venous Catheter Infections : Comparison of the Efficacy of Skin Disinfection With 5% Povidone Iodine in Alcoholic Solution Versus 0.25% Chlorhexidine, 0.025 Benzalkonium and 4% Benzylic Alcohol
- ClinicalTrials.gov ID
- NCT00259350
- Acronym / sponsor ID
- Anticath
- Keywords
- Central venous catheter, Skin disinfection, Antisepsis, Nosocomial infection, Catheter infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Apr 2006
- First posted
- 29 Nov 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.
The best antiseptic solution for cateheter care remains unknown.High concentration in aquous solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone iodine in aquous solutions. No study has compare alcoholic formulations of low concentration of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central venous catheters.
To compare the incidence of central venous catheter colonization after skin disinfection with either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine, 0.025% Benzalkonium and 4% benzylic alcohol.
To compare the incidence of catheter related bacteremia in the to study groups. To compare the local and general tolerance of the two antiseptic formulations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 yeras of age
- Requiring an internal jugular or sub-clavian central venous catheter for their care during at least 72 h
- Informed consent signed up
Key exclusion criteria (3 listed)
- Bacteriemic infection not under control
- extensive cutaneous infection
- Women with childbearing potential
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 | Drug | – |
Primary outcome
Prevention of catheter colonization
3 secondary outcomes
Prevention of catheter related bacteremia
Prevention of a positive culture of the catheter whaterver the threshold
Local and general tolerance
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 27 Jan 2009.
- Derived from this study: PubMed 17954800Mimoz O, Villeminey S, Ragot S, Dahyot-Fizelier C, Laksiri L, Petitpas F, Debaene B. Chlorhexidine-based antiseptic solution vs alcohol-based povidone-iodine for central venous catheter care. Arch Intern Med. 2007 Oct 22;167(19):2066-72. doi: 10.1001/archinte.167.19.2066.
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.
Olivier MIMOZ, MD, PhD study chair
University Hospital of Poitiers, france
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 Skin disinfection in people with ICU Patients Requiring a Central Venous Access, 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 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 27 Jan 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 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?
Prevention of catheter colonization. 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 NCT00259350, which also lists 1 linked publication.
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 27 Jan 2009.