Antibiotic Resistant InfectionPhase 3NCT01989416
Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients
A Phase 3 study testing 2% chlorhexidine wipe and Soap in people with Antibiotic Resistant Infection, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing of colonization of multi-drug resistant bacteria in intensive care unit patients. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Antibiotic Resistant Infection
- What is being tested?
- 2% chlorhexidine wipe and Soap
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 481 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2013to Apr 2015
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Admission in critical care unit eg. ICU, respiratory care unit, Cardiac care unit with in 24 hours
- Expected duration of critical care unit admission > 48 hours
Who cannot join
- History of chlorhexidine allergy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing of colonization of multi-drug resistant bacteria in intensive care unit patients.
Read the detailed description
The purpose of this study is to evaluate the usefulness of bathing with chlorhexidine wipe to reduce the risks of multidrug resistant bacteria acquisition and hospital-acquired bloodstream infection among ICU patients
- Conditions
- Antibiotic Resistant Infection
- Being tested
- 2% chlorhexidine wipe, Soap
- Keywords
- colonization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% chlorhexidine wipeDrug
Also called chlorhexidine wipe
The ICU patients will be bathing with 2% chlorhexidine wipe
SoapDrug
Also called Control soap
The ICU patients will be bathing with Soap
| Study group | Role | What they receive |
|---|---|---|
| Soap bathing | Placebo comparator | ICU patients will be bathing with soap at least once daily Receives: Drug: Soap |
| 2% chlorhexidine wipes | Experimental | Use 2% chlorhexidine wipes to clean the patient at least once daily Receives: Drug: 2% chlorhexidine wipe |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing
7 days after received 2% chlorhexidine wipes,the microbiology laboratory will process surveillance specimens using either standard culture-based at both nostrils, axillar, groins, rectum
Measured: 7 days after recieved 2% chlorhexidine wipes
Secondary outcomes (1)
The overall rate of hospital-acquired bloodstream infections per 1000 patient-days with chlorhexidine wipe bathing versus with soap bathing
Measured: 48 hours after recieved 2% chlorhexidine wipes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2015
- Study completionApr 2015
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 Antibiotic Resistant InfectionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adhiratha Boonyasiri, Mahidol University
- Investigators
- Adhiratha Boonyasiri, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989416
- Sponsor's protocol ID
- 567-2556-EC4
- Status last verified
- Nov 2015
- First submitted
- 13 Oct 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boonyasiri A, Thaisiam P, Permpikul C, Judaeng T, Suiwongsa B, Apiradeewajeset N, Fakthongphan T, Suddee S, Laoagtipparos W, Thamlikitkul V. Effectiveness of Chlorhexidine Wipes for the Prevention of Multidrug-Resistant Bacterial Colonization and Hospital-Acquired Infections in Intensive Care Unit Patients: A Randomized Trial in Thailand. Infect Control Hosp Epidemiol. 2016 Mar;37(3):245-53. doi: 10.1017/ice.2015.285.
PubMed 26894621
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT01989416
- Acronym / sponsor ID
- 567-2556-EC4
- Conditions
- Antibiotic Resistant Infection
- Keywords
- colonization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Nov 2013 (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 determine 2% chlorhexidine wipes are effective in preventing of colonization of multi-drug resistant bacteria in intensive care unit patients.
Detailed description
The purpose of this study is to evaluate the usefulness of bathing with chlorhexidine wipe to reduce the risks of multidrug resistant bacteria acquisition and hospital-acquired bloodstream infection among ICU patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soap bathing | Placebo comparator | Drug: SoapICU patients will be bathing with soap at least once daily |
| 2% chlorhexidine wipes | Experimental | Drug: 2% chlorhexidine wipeUse 2% chlorhexidine wipes to clean the patient at least once daily |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Admission in critical care unit eg. ICU, respiratory care unit, Cardiac care unit with in 24 hours
- Expected duration of critical care unit admission > 48 hours
Key exclusion criteria (1 listed)
- History of chlorhexidine allergy
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 |
|---|---|---|
| 2% chlorhexidine wipeAlso: chlorhexidine wipeThe ICU patients will be bathing with 2% chlorhexidine wipe | Drug | 2% chlorhexidine wipes |
| SoapAlso: Control soapThe ICU patients will be bathing with Soap | Drug | Soap bathing |
Primary outcome
The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing
Time frame: 7 days after recieved 2% chlorhexidine wipes
7 days after received 2% chlorhexidine wipes,the microbiology laboratory will process surveillance specimens using either standard culture-based at both nostrils, axillar, groins, rectum
1 secondary outcome
The overall rate of hospital-acquired bloodstream infections per 1000 patient-days with chlorhexidine wipe bathing versus with soap bathing
Time frame: 48 hours after recieved 2% chlorhexidine wipes
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 2 Dec 2015.
- Derived from this study: PubMed 26894621Boonyasiri A, Thaisiam P, Permpikul C, Judaeng T, Suiwongsa B, Apiradeewajeset N, Fakthongphan T, Suddee S, Laoagtipparos W, Thamlikitkul V. Effectiveness of Chlorhexidine Wipes for the Prevention of Multidrug-Resistant Bacterial Colonization and Hospital-Acquired Infections in Intensive Care Unit Patients: A Randomized Trial in Thailand. Infect Control Hosp Epidemiol. 2016 Mar;37(3):245-53. doi: 10.1017/ice.2015.285.
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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.
Adhiratha Boonyasiri, MD principal investigator
Mahidol University
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 2% chlorhexidine wipe and Soap in people with Antibiotic Resistant Infection, run by Mahidol University at 1 site in Thailand.
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 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 2 Dec 2015. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing (time frame: 7 days after recieved 2% chlorhexidine wipes). 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 NCT01989416, 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 2 Dec 2015.