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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02502682
Other study ID # CDiff070115
Secondary ID
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


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
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