Sepsis Affecting SkinPhase 4NCT03489512
Comparison Trial for Chloraprep Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia
A Phase 4 study testing A (Chloraprep) and B (Clorhexidine 2%) in people with Sepsis Affecting Skin and Central Venous Catheter Related Bacteremia, run by Instituto de Investigacion Sanitaria La Fe.
Trial summary
A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis Affecting Skin, Central Venous Catheter Related Bacteremia
- What is being tested?
- A (Chloraprep) and B (Clorhexidine 2%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Apr 2021
- 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 admitted to the ICU.
- Patients with age greater than or equal to 18 years.
- Patients who require at least one central venous catheters during 48h or more.
- Obtaining informed consent.
Who cannot join
- Intolerance or known allergy to chlorhexidine, isopropyl alcohol or orange yellow S (E110).
- High probability of death within 48 hours after admission.
- Use of coated catheter.
- Previously included in the study.
About this study
Official title: Clinical Phase IV Comparison Trial for 2% Chlorhexidine Skin Asepsis +70% Alcohol Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia in Critical Patients: Preliminary Study
A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). The incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated.
Read the detailed description
A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). The incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated.
The patients will assigned to the treatment group depending on where and when they are treated (site A or site B) and will continue the treatment until the end (continuous design): the patients of Site A will receive the first treatment option and those of Site B will receive the second treatment option during the first 6 months. After this, a rest period of 1 month will be established, during which patients will not be recruited and any of the two cutaneous aseptic methods will be used indiscriminately, in the opinion of the responsible nursing staff. After the resting period, the treatments will be reversed during the following 6 months.
- Being tested
- A (Chloraprep), B (Clorhexidine 2%)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A (Chloraprep)Drug
Also called Chloraprep
Chloraprep will be used for the insertion and maintenance of the intravascular device while it is in use (Chlorhexidine 2% + alcohol 70%)
B (Clorhexidine 2%)Drug
Also called Clorhexidine 2%
Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use
| Study group | Role | What they receive |
|---|---|---|
| A (Chloraprep) | Experimental | 2% chlorhexidine gluconate with 70% isopropyl alcohol with a sterile 3ml single dose applicator. Use for the preparation of the skin before insertion of the central venous catheters and at each dressing change. Receives: Drug: A (Chloraprep) |
| B (Clorhexidine 2%) | Active comparator | 2% aqueous base chlorhexidine (10 ml single dose containers). Use for the preparation of the skin before insertion of the central venous catheters and at each dressing change. Receives: Drug: B (Clorhexidine 2%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter-related bacteremia
Measure the effect of cutaneous asepsis with chlorhexidine gluconate 2% + isopropyl gluconate 70% on the incidence of catheter-related bacteremia in the critical patient with respect to the control group.
Measured: Up to 48 hours after discharge from the ICU.
Secondary outcomes (2)
Incidence of pericatheter skin colonization
Measure the effect that cutaneous asepsis with chlorhexidine gluconate 2% + isopropyl 70% has on the incidence of pericatheter skin colonization with respect to the control group.
Measure with a microbiological culture from the skin area
Measured: Through study completion, an average of 1 year
Incidence of colonization of the central venous catheter
Measure the effect of cutaneous asepsis with chlorhexidine gluconate 2% + isopropyl 70% on the incidence of colonization of the central venous catheter with respect to the control group.
Culture of the tip of the removed catheter.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
Why it stopped: Administrative issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis Affecting SkinStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will receive one or the other treatment depending on where and when they are treated and will continue the treatment until the end.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paula Ramirez Galleymore, Principal investigator, Hospital La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489512
- Sponsor's protocol ID
- CHLORAPREP
- Status last verified
- Aug 2019
- First submitted
- 14 Mar 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phase IV Comparison Trial for 2% Chlorhexidine Skin Asepsis +70% Alcohol Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia in Critical Patients: Preliminary Study
- ClinicalTrials.gov ID
- NCT03489512
- Acronym / sponsor ID
- CHLORAPREP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 5 Apr 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.
A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). The incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated.
Detailed description
A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). The incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated.
The patients will assigned to the treatment group depending on where and when they are treated (site A or site B) and will continue the treatment until the end (continuous design): the patients of Site A will receive the first treatment option and those of Site B will receive the second treatment option during the first 6 months. After this, a rest period of 1 month will be established, during which patients will not be recruited and any of the two cutaneous aseptic methods will be used indiscriminately, in the opinion of the responsible nursing staff. After the resting period, the treatments will be reversed during the following 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will receive one or the other treatment depending on where and when they are treated and will continue the treatment until the end.
| Arm | Type | Receives |
|---|---|---|
| A (Chloraprep) | Experimental | Drug: A (Chloraprep)2% chlorhexidine gluconate with 70% isopropyl alcohol with a sterile 3ml single dose applicator. Use for the preparation of the skin before insertion of the central venous catheters and at each dressing change. |
| B (Clorhexidine 2%) | Active comparator | Drug: B (Clorhexidine 2%)2% aqueous base chlorhexidine (10 ml single dose containers). Use for the preparation of the skin before insertion of the central venous catheters and at each dressing change. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted to the ICU.
- Patients with age greater than or equal to 18 years.
- Patients who require at least one central venous catheters during 48h or more.
- Obtaining informed consent.
Key exclusion criteria (4 listed)
- Intolerance or known allergy to chlorhexidine, isopropyl alcohol or orange yellow S (E110).
- High probability of death within 48 hours after admission.
- Use of coated catheter.
- Previously included in 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 |
|---|---|---|
| A (Chloraprep)Also: ChloraprepChloraprep will be used for the insertion and maintenance of the intravascular device while it is in use (Chlorhexidine 2% + alcohol 70%) | Drug | A (Chloraprep) |
| B (Clorhexidine 2%)Also: Clorhexidine 2%Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use | Drug | B (Clorhexidine 2%) |
Primary outcome
Incidence of catheter-related bacteremia
Time frame: Up to 48 hours after discharge from the ICU.
Measure the effect of cutaneous asepsis with chlorhexidine gluconate 2% + isopropyl gluconate 70% on the incidence of catheter-related bacteremia in the critical patient with respect to the control group.
2 secondary outcomes
Incidence of pericatheter skin colonization
Time frame: Through study completion, an average of 1 year
Incidence of colonization of the central venous catheter
Time frame: Through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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.
Paula Ramirez Galleymore principal investigator
Hospital La Fe
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing A (Chloraprep) and B (Clorhexidine 2%) in people with Sepsis Affecting Skin and Central Venous Catheter Related Bacteremia, run by Instituto de Investigacion Sanitaria La Fe.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 bacteremia (time frame: Up to 48 hours after discharge from the ICU.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2020.