Infectious DiseasesPhase 3NCT01361997
Isopropyl Alcohol Against Chlorhexidine - Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination
A Phase 3 study testing chlorhexidine in isopropyl alcohol and Isopropyl alcohol in people with Infectious Diseases, run by Universidad de Guanajuato at 1 site in Mexico.
Trial summary
The purpose of this study is to determinate if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70% isopropyl alcohol. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Infectious Diseases
- What is being tested?
- chlorhexidine in isopropyl alcohol and Isopropyl alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,102 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2011to Aug 2012
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected blood stream infection.
- Patients allocated in admission, hospitalization and intensive care units.
Who cannot join
- Patients with a single peripheral hemoculture.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
University of Guanajuato School of Medicine
León, Guanajuato, 37000
About this study
Official title: Comparative Study of 70% Isopropyl Alcohol Against 2% Chlorhexidine- 70% Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination
The purpose of this study is to determinate if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70% isopropyl alcohol.
Read the detailed description
The develop of contaminants in blood cultures is a problem of great impact to health institutions and patients, as they represent a waste of resources, and additionally increases the patient's hospital stay. The principal source of contaminant is the bacteria in the skin flora, so the greatest way to improve the sensibility of this test is to do an optimal skin antisepsis. It has been reported that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior that other skin disinfectants, and that 70% isopropyl alcohol has a high efficacy reducing the presence of bacteria on the skin, so both antiseptics are good options for skin antisepsis.
- Conditions
- Infectious Diseases
- Being tested
- chlorhexidine in isopropyl alcohol, Isopropyl alcohol
- Keywords
- Antiseptics, Hemoculture contamination, Anti-infecting agents, local
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidine in isopropyl alcoholBiological
Also called Chloraprep, Enturia Inc., Texas., BacT/ALERT FA, Biomérieux Inc., North Carolina.
When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.
Isopropyl alcoholBiological
Also called Alcohol Swabs, BD, Madrid., BacT/ALERT FA, Biomérieux Inc., North Carolina.
When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine in isopropyl alcohol | Experimental | This arm is composed of 545 hospitalized patients with suspected blood stream infection, to test 2% chlorhexidine gluconate in 70% isopropyl alcohol. Receives: Biological: chlorhexidine in isopropyl alcohol |
| Isopropyl alcohol | Experimental | This arm is composed of 572 hospitalized patients with suspected blood stream infection, to test 70% isopropyl alcohol. Receives: Biological: Isopropyl alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemoculture, compared with 2% chlorhexidine in 70% isopropyl alcohol.
It will determine the growth of contaminating germs in hemocultures taken with each antiseptic tested.
Measured: 120 hours
Secondary outcomes (2)
Determine the rate of contamination of each antiseptic used.
It will determine the rate of contamination at the date of primary completion and the date of study completion. We will consider contaminants the development of Staphylococcus coagulase negative and gram positive bacilli.
Measured: 1 year
Description of the most frequent bacterial contaminants.
It will determine the rate of contamination at the date of primary completion and the date of study completion. We will consider contaminants the development of Staphylococcus coagulase negative and gram positive bacilli.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseasesStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Guanajuato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro E. Macias, Universidad de Guanajuato
- Investigators
- Alejandro E. Macias, M. D., Principal investigator, Universidad de Guanajuato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361997
- Sponsor's protocol ID
- 2011HRAEB001
- Status last verified
- Aug 2012
- First submitted
- 23 May 2011
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of 70% Isopropyl Alcohol Against 2% Chlorhexidine- 70% Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination
- ClinicalTrials.gov ID
- NCT01361997
- Acronym / sponsor ID
- 2011HRAEB001
- Conditions
- Infectious Diseases
- Keywords
- Antiseptics, Hemoculture contamination, Anti-infecting agents, local
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,102 participants (actual)
- Lead sponsor
- Universidad de GuanajuatoUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 May 2011 (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 purpose of this study is to determinate if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70% isopropyl alcohol.
Detailed description
The develop of contaminants in blood cultures is a problem of great impact to health institutions and patients, as they represent a waste of resources, and additionally increases the patient's hospital stay. The principal source of contaminant is the bacteria in the skin flora, so the greatest way to improve the sensibility of this test is to do an optimal skin antisepsis. It has been reported that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior that other skin disinfectants, and that 70% isopropyl alcohol has a high efficacy reducing the presence of bacteria on the skin, so both antiseptics are good options for skin antisepsis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine in isopropyl alcohol | Experimental | Biological: chlorhexidine in isopropyl alcoholThis arm is composed of 545 hospitalized patients with suspected blood stream infection, to test 2% chlorhexidine gluconate in 70% isopropyl alcohol. |
| Isopropyl alcohol | Experimental | Biological: Isopropyl alcoholThis arm is composed of 572 hospitalized patients with suspected blood stream infection, to test 70% isopropyl alcohol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with suspected blood stream infection.
- Patients allocated in admission, hospitalization and intensive care units.
Key exclusion criteria (1 listed)
- Patients with a single peripheral hemoculture.
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 |
|---|---|---|
| chlorhexidine in isopropyl alcoholAlso: Chloraprep, Enturia Inc., Texas., BacT/ALERT FA, Biomérieux Inc., North Carolina.When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C. | Biological | Chlorhexidine in isopropyl alcohol |
| Isopropyl alcoholAlso: Alcohol Swabs, BD, Madrid., BacT/ALERT FA, Biomérieux Inc., North Carolina.When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C. | Biological | Isopropyl alcohol |
Primary outcome
Determine if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemoculture, compared with 2% chlorhexidine in 70% isopropyl alcohol.
Time frame: 120 hours
It will determine the growth of contaminating germs in hemocultures taken with each antiseptic tested.
2 secondary outcomes
Determine the rate of contamination of each antiseptic used.
Time frame: 1 year
Description of the most frequent bacterial contaminants.
Time frame: 1 year
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 19 Aug 2016.
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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.
Alejandro E. Macias, M. D. principal investigator
Universidad de Guanajuato
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 chlorhexidine in isopropyl alcohol and Isopropyl alcohol in people with Infectious Diseases, run by Universidad de Guanajuato at 1 site in Mexico.
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 2 inclusion and 1 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 19 Aug 2016. 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 Mexico. 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?
Determine if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemoculture, compared with 2% chlorhexidine in 70% isopropyl alcohol. (time frame: 120 hours). 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 19 Aug 2016.