Chlorhexidine Bathing Effect on Clostridium Difficile Rates | NCT02502682

Studies
Chlorhexidine Bathing Effect on Clostridium Difficile Rates

NCT02502682

Sponsor

Jared Brooks

Status

Completed

Last Update Posted

Jul 11, 2016Estimated

Enrollment

167Actual

Phase

Phase 2

Conditions

Clostridium Difficile

Interventions

Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Jul 14, 2015

First Submission Date that Met QC Criteria

Jul 17, 2015

First Posted Date

Jul 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2016

Last Update Posted Date

Jul 11, 2016Estimated

Name	Class
Northwestern Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

167Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Receive the bathing standard of care.
Interventional	Experimental	Receive daily bathing with 2% Chlorhexidine gluconate bathing wipes.	Drug: Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation	Drug	Daily bathing.	Interventional

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	up to 12 months
Duration of Hospital stays		expected average of six days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Prescription of antibiotics for suspected or confirmed infection.
Admitted to the 2600 General/Medical ward at Delnor Hospital.

Exclusion Criteria:

Antibiotics only for surgical prophylaxis
Not mentally capable
Cannot provide consent in English
Pregnant
Documented chlorhexidine allergy
Patient is a prisoner
Health system employee

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian Poustinchian, D.O.	Hospitalist - Northwestern Medicine Regional Medical Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern Medicine - Delnor Hospital		Geneva	Illinois	60134	United States