Chlorhexidine Bathing Effect on Clostridium Difficile Rates

Clostridium Difficile Clinical Trial

Official title:

Effect of Daily Chlorhexidine Bathing on Clostridium Difficile Rates on the General Medical Floor in Patients Receiving Antibiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502682
• Other study ID #: CDiff070115
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2015
• Last updated: July 6, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Northwestern Medicine Delnor Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Clostridium Difficile

Intervention

Drug:
• Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation
Daily bathing.

Locations

Country	Name	City	State
United States	Northwestern Medicine - Delnor Hospital	Geneva	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Jared Brooks	Northwestern Medicine Delnor Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Duration of Hospital stays		expected average of six days	No