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Efficacy Of Copper To Reduce Acquisition Of Microbes and Healthcare-acquired Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565798
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : March 24, 2016
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Ralph H. Johnson VA Medical Center
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE March 26, 2012
First Posted Date  ICMJE March 29, 2012
Last Update Posted Date March 24, 2016
Study Start Date  ICMJE July 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room. [ Time Frame: July 2010 to June 2011 (up to 1 year) ]
Patients prospectively followed from ICU admission to hospital discharge for acquisition of HAI and/or colonization with MRSA or VRE
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
Microbial burden and risk of HAI [ Time Frame: July 2010 to June 2011 (up to 1 year) ]
The risk of HAI among patients admitted to ICU will be assessed by microbial burden of environment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Of Copper To Reduce Acquisition Of Microbes and Healthcare-acquired Infections
Official Title  ICMJE Copper Antimicrobial Research Program: Environmental and Patient Sampling For Indicator Organisms To Determine The Efficacy Of Copper To Reduce Acquisition Of Microbes From The Patient Care Environment
Brief Summary

CONTEXT: Healthcare-acquired infections (HAI) cause substantial patient morbidity and mortality. Commonly touched items in the patient care environment harbor microorganisms that may contribute to HAI risk. Thus, reduction in the surface bioburden may be an effective strategy to reduce HAI. Inherent biocidal capabilities of copper surfaces offer a theoretical advantage to conventional cleaning, as disinfection is continuous rather than episodic.

OBJECTIVE: Determine whether placement of copper-alloy surfaced objects in an intensive care unit (ICU) reduce risk of HAI.

DESIGN: An intention to treat study where patients are sequentially placed into rooms with or without copper-alloy surfaced objects.

SETTING: The ICUs of three hospitals, a tertiary academic hospital, an academic cancer center, and a Veteran's Administration Medical Center.

PATIENTS: Any patient 18 years of age or older who required admission to an ICU at a study hospital is eligible for placement into a study room if available.

INTERVENTION: Placement of copper-alloy surfaced objects in an ICU room. MAIN OUTCOME MEASURE: Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthcare-acquired Infection
Intervention  ICMJE Other: Copper-alloy surfaced patient care objects
Copper-alloy surfaced bed rails, over bed tray tables, chair arms, nurse call devices, laptop and computer monitor bezels, and IV poles were placed into the patient ICU rooms.
Study Arms  ICMJE
  • Experimental: Copper Surfaced Room
    Patients sequentially randomized to this arm were admitted to an ICU room with copper surfaced objects.
    Intervention: Other: Copper-alloy surfaced patient care objects
  • No Intervention: Standard Surfaced Room
    Patients sequentially randomized to this arm were admitted to an ICU room with standard surfaced objects
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2012)
614
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

patients 18 years and older requiring admission to an ICU at one of the study sites were eligible

Exclusion Criteria:

  • less than 18 years of age or
  • pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01565798
Other Study ID Numbers  ICMJE DOD W81XWH-07-C-0053
Effect of Copper on HAI ( Other Grant/Funding Number: U.S. Army Material Command Contract W81XWH-07-C-0053 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE
  • Memorial Sloan Kettering Cancer Center
  • Ralph H. Johnson VA Medical Center
Investigators  ICMJE
Principal Investigator: Michael G Schmidt, PhD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP