Chlorhexidine Bathing Effect on Clostridium Difficile Rates

NCT02502682 | Completed Phase 2

• 1 other identifier: CDiff070115
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile

Keywords

Chlorhexidine bathing

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation DRUG

Daily bathing.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jared Brooks: lead
• Northwestern Medicine: collaborator

Study Sites (1)

Northwestern Medicine - Delnor Hospital

Geneva, Illinois, 60134, United States

Location

Study Officials

• Brian Poustinchian, D.O.

  Hospitalist - Northwestern Medicine Regional Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

US (1)