Healthcare-acquired InfectionNCT01565798
Efficacy Of Copper To Reduce Acquisition Of Microbes and Healthcare-acquired Infections
A study testing Copper-alloy surfaced patient care objects in people with Healthcare-acquired Infection, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare-acquired Infection
- What is being tested?
- Copper-alloy surfaced patient care objects
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients 18 years and older requiring admission to an ICU at one of the study sites were eligible
Who cannot join
- less than 18 years of age or
- pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Healthcare-acquired Infection
- Being tested
- Copper-alloy surfaced patient care objects
- Keywords
- healthcare-acquired infections, colonization, copper-alloy surfaces
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper-alloy surfaced patient care objectsOther
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 group | Role | What they receive |
|---|---|---|
| Copper Surfaced Room | Experimental | Patients sequentially randomized to this arm were admitted to an ICU room with copper surfaced objects. Receives: Other: Copper-alloy surfaced patient care objects |
| Standard Surfaced Room | No intervention | Patients sequentially randomized to this arm were admitted to an ICU room with standard surfaced objects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of incident HAI and/or colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE) in each type of room.
Patients prospectively followed from ICU admission to hospital discharge for acquisition of HAI and/or colonization with MRSA or VRE
Measured: July 2010 to June 2011 (up to 1 year)
Secondary outcomes (1)
Microbial burden and risk of HAI
The risk of HAI among patients admitted to ICU will be assessed by microbial burden of environment.
Measured: July 2010 to June 2011 (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJul 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare-acquired InfectionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, Ralph H. Johnson VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Michael G Schmidt, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565798
- Sponsor's protocol ID
- DOD W81XWH-07-C-0053
- Other IDs
- Effect of Copper on HAI
- Status last verified
- Dec 2011
- First submitted
- 26 Mar 2012
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01565798
- Acronym / sponsor ID
- DOD W81XWH-07-C-0053
- Conditions
- Healthcare-acquired Infection
- Keywords
- healthcare-acquired infections, colonization, copper-alloy surfaces
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center, Ralph H. Johnson VA Medical Center
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Copper Surfaced Room | Experimental | Other: Copper-alloy surfaced patient care objectsPatients sequentially randomized to this arm were admitted to an ICU room with copper surfaced objects. |
| Standard Surfaced Room | No intervention | –Patients sequentially randomized to this arm were admitted to an ICU room with standard surfaced objects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients 18 years and older requiring admission to an ICU at one of the study sites were eligible
Key exclusion criteria (2 listed)
- less than 18 years of age or
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copper-alloy surfaced patient care objectsCopper-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. | Other | Copper Surfaced Room |
Primary outcome
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
1 secondary outcome
Microbial burden and risk of HAI
Time frame: July 2010 to June 2011 (up to 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
Related trials for Healthcare-acquired Infection
Not yet recruiting
Combating HIV Stigma in Healthcare Settings: A Standardized Patient Approach
Hiv
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Recruiting
Striving Towards EmPowerment and Medication Adherence R01
Hiv, Mental Health Issue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G Schmidt, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copper-alloy surfaced patient care objects in people with Healthcare-acquired Infection, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: July 2010 to June 2011 (up to 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.