Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients

Antibiotic Resistant Infection Clinical Trial

Official title:

Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989416
• Other study ID #: 567-2556-EC4
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2013
• Last updated: November 30, 2015
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: November 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing of colonization of multi-drug resistant bacteria in intensive care unit patients.

Description:

The purpose of this study is to evaluate the usefulness of bathing with chlorhexidine wipe to reduce the risks of multidrug resistant bacteria acquisition and hospital-acquired bloodstream infection among ICU patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Age > 18 years

• Admission in critical care unit eg. ICU, respiratory care unit, Cardiac care unit with in 24 hours

• Expected duration of critical care unit admission > 48 hours

Exclusion Criteria:

• History of chlorhexidine allergy

Study Design

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection

Intervention

Drug:
• 2% chlorhexidine wipe
The ICU patients will be bathing with 2% chlorhexidine wipe
• Soap
The ICU patients will be bathing with Soap

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall rate of Multidrug resistant bacteria acquisition at 7 days after received 2% chlorhexidine wipe bathing versus with soap bathing	7 days after received 2% chlorhexidine wipes,the microbiology laboratory will process surveillance specimens using either standard culture-based at both nostrils, axillar, groins, rectum	7 days after recieved 2% chlorhexidine wipes	Yes
Secondary	The overall rate of hospital-acquired bloodstream infections per 1000 patient-days with chlorhexidine wipe bathing versus with soap bathing		48 hours after recieved 2% chlorhexidine wipes	Yes