Clostridium DifficilePhase 2NCT02502682
Chlorhexidine Bathing Effect on Clostridium Difficile Rates
A Phase 2 study testing Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation in people with Clostridium Difficile, run by Jared Brooks at 1 site in United States.
Trial summary
Clostridium difficile (C. diff.) infections, whether nosocomial or community borne, may present with profound diarrhea, especially in those patients receiving antibiotics. Based on a preliminary review of hospital data, the investigators have found that these symptomatic c. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2016
- Phase
- Phase 2
- 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
- Prescription of antibiotics for suspected or confirmed infection.
- Admitted to the 2600 General/Medical ward at Delnor Hospital.
Who cannot join
- Antibiotics only for surgical prophylaxis
- Not mentally capable
- Cannot provide consent in English
- Pregnant
- Documented chlorhexidine allergy
- Patient is a prisoner
- Health system employee
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medicine - Delnor Hospital
Geneva, Illinois, 60134
About this study
Official title: Effect of Daily Chlorhexidine Bathing on Clostridium Difficile Rates on the General Medical Floor in Patients Receiving Antibiotics
Clostridium difficile (C. diff.) infections, whether nosocomial or community borne, may present with profound diarrhea, especially in those patients receiving antibiotics. Based on a preliminary review of hospital data, the investigators have found that these symptomatic c. diff infections occur with a relatively high incidence at Delnor Hospital. Notwithstanding their high mortality, one recent study attributes a near quadrupling of hospitalization costs to c. diff infections. Chlorhexidine baths have been shown in multiple randomized trials to help reduce the incidence of highly virulent pathogens and hospital acquired infections. Further, several studies show a favorable effect of reducing the incidence of c. diff infections by using Chlorhexidine baths on ICU patients. Far fewer studies, however, have focused on the effects of these baths on general medical/surgical wards. This investigation seeks to study the effect of the daily use of 2% Chlorhexidine gluconate wipes in patients on the general medical/surgical wards who are exposed to antibiotics for a suspected or confirmed infection.
- Conditions
- Clostridium Difficile
- Being tested
- Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation
- Keywords
- Chlorhexidine bathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin PreparationDrug
Daily bathing.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receive the bathing standard of care. |
| Interventional | Experimental | Receive daily bathing with 2% Chlorhexidine gluconate bathing wipes. Receives: Drug: Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Relative Risk of C-diff infection
Study data will cease to be collected after 300 participants have been enrolled or until 12 months have elapsed. Data will be collected and assessed monthly.
Measured: up to 12 months
Duration of Hospital stays
Measured: expected average of six days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jared Brooks
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Medicine
- Responsible party
- Sponsor-investigator, Jared Brooks, Northwestern Medicine
- Investigators
- Brian Poustinchian, D.O., Principal investigator, Hospitalist - Northwestern Medicine Regional Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502682
- Sponsor's protocol ID
- CDiff070115
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2015
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Chlorhexidine Bathing on Clostridium Difficile Rates on the General Medical Floor in Patients Receiving Antibiotics
- ClinicalTrials.gov ID
- NCT02502682
- Acronym / sponsor ID
- CDiff070115
- Conditions
- Clostridium Difficile
- Keywords
- Chlorhexidine bathing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Jared BrooksUniversity, hospital or other
- Collaborators
- Northwestern Medicine
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Jul 2015 (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.
Clostridium difficile (C. diff.) infections, whether nosocomial or community borne, may present with profound diarrhea, especially in those patients receiving antibiotics. Based on a preliminary review of hospital data, the investigators have found that these symptomatic c. diff infections occur with a relatively high incidence at Delnor Hospital. Notwithstanding their high mortality, one recent study attributes a near quadrupling of hospitalization costs to c. diff infections. Chlorhexidine baths have been shown in multiple randomized trials to help reduce the incidence of highly virulent pathogens and hospital acquired infections. Further, several studies show a favorable effect of reducing the incidence of c. diff infections by using Chlorhexidine baths on ICU patients. Far fewer studies, however, have focused on the effects of these baths on general medical/surgical wards. This investigation seeks to study the effect of the daily use of 2% Chlorhexidine gluconate wipes in patients on the general medical/surgical wards who are exposed to antibiotics for a suspected or confirmed infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Receive the bathing standard of care. |
| Interventional | Experimental | Drug: Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin PreparationReceive daily bathing with 2% Chlorhexidine gluconate bathing wipes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prescription of antibiotics for suspected or confirmed infection.
- Admitted to the 2600 General/Medical ward at Delnor Hospital.
Key exclusion criteria (7 listed)
- Antibiotics only for surgical prophylaxis
- Not mentally capable
- Cannot provide consent in English
- Pregnant
- Documented 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 |
|---|---|---|
| Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin PreparationDaily bathing. | Drug | Interventional |
Primary outcome
Number of participants with Relative Risk of C-diff infection
Time frame: up to 12 months
Study data will cease to be collected after 300 participants have been enrolled or until 12 months have elapsed. Data will be collected and assessed monthly.
Duration of Hospital stays
Time frame: expected average of six days
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 Jul 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.
Brian Poustinchian, D.O. principal investigator
Hospitalist - Northwestern Medicine Regional Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation in people with Clostridium Difficile, run by Jared Brooks at 1 site in United States.
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 7 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 Jul 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of participants with Relative Risk of C-diff infection (time frame: up to 12 months). The study lists 2 primary outcomes in all. 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 Jul 2016.