Nosocomial InfectionsNCT01678612
Efficacy of Copper in Reducing Health-Acquired Infections in a Pediatric Intensive Care Unit
A study testing Copper-alloy surfaced objects in people with Nosocomial Infections, run by Codelco at 1 site in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 days to 180 months
- Conditions the study is for
- Nosocomial Infections
- What is being tested?
- Copper-alloy surfaced objects
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,012 participants
- Where
- 1 siteChile
- Study dates
- Nov 2012to Dec 2013
- 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 7 days to 180 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patient admitted to PICU
- stay at PICU > 24 hours
- informed consent by parent/legal representative
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Copper in Reducing Health-Acquired Infections and Microbial Burden as Measured on High Touch Surfaces in a Pediatric Intensive Care Unit. A Controlled Clinical Trial.
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. The purpose of this study is to assess whether placement of copper-alloy surfaced objects in a pediatric intensive care unit (PICU) reduce risk of HAI in comparison with non-copper surfaced objects.
- Conditions
- Nosocomial Infections
- Being tested
- Copper-alloy surfaced objects
- Keywords
- Copper, Health-Acquired Infections, Bacterial Load, Intensive Care Units, Pediatric
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper-alloy surfaced objectsOther
Room assigned to the Experimental arm will be furnished with copper-alloy surfaced objects,i.e. bed-rails, bed-rail levers, IV poles, nurse workstation, HCW clipboards, sink handles.
| Study group | Role | What they receive |
|---|---|---|
| Non copper standard surfaced objects | No intervention | Rooms assigned to standard surfaced objects |
| Copper-alloy surfaced objects | Experimental | Rooms furnished with copper surfaced objects, i.e. bed rails, bed rail levers, IV poles, nurse workstation, clipboards, sink handles. Receives: Other: Copper-alloy surfaced objects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-Acquired Infections (HAI) incidence density / 1,000 patient-days
Measured: Participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary outcomes (1)
Microbial Burden measured on high-touch copper and non-copper surfaced objects
Total microbial burden and selected bacteria (MRSA,VRE) will be measured twice a month in all bedrails and sink handles of the PICU study site.
Measured: 1 year study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codelco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bettina von Dessauer, MD, Principal investigator, Hospital Roberto del Rio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678612
- Sponsor's protocol ID
- CODEHRdR
- Status last verified
- Apr 2014
- First submitted
- 25 Aug 2012
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Copper in Reducing Health-Acquired Infections and Microbial Burden as Measured on High Touch Surfaces in a Pediatric Intensive Care Unit. A Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT01678612
- Acronym / sponsor ID
- CODEHRdR
- Conditions
- Nosocomial Infections
- Keywords
- Copper, Health-Acquired Infections, Bacterial Load, Intensive Care Units, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- CodelcoIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Sep 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.
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. The purpose of this study is to assess whether placement of copper-alloy surfaced objects in a pediatric intensive care unit (PICU) reduce risk of HAI in comparison with non-copper surfaced objects.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non copper standard surfaced objects | No intervention | –Rooms assigned to standard surfaced objects |
| Copper-alloy surfaced objects | Experimental | Other: Copper-alloy surfaced objectsRooms furnished with copper surfaced objects, i.e. bed rails, bed rail levers, IV poles, nurse workstation, clipboards, sink handles. |
Who may qualify
- Ages
- 7 days to 180 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patient admitted to PICU
- stay at PICU > 24 hours
- informed consent by parent/legal representative
Key exclusion criteria (0 listed)
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 objectsRoom assigned to the Experimental arm will be furnished with copper-alloy surfaced objects,i.e. bed-rails, bed-rail levers, IV poles, nurse workstation, HCW clipboards, sink handles. | Other | Copper-alloy surfaced objects |
Primary outcome
Hospital-Acquired Infections (HAI) incidence density / 1,000 patient-days
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days
1 secondary outcome
Microbial Burden measured on high-touch copper and non-copper surfaced objects
Time frame: 1 year study duration
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 10 Apr 2014.
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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.
Bettina von Dessauer, MD principal investigator
Hospital Roberto del Rio
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 objects in people with Nosocomial Infections, run by Codelco at 1 site in Chile.
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 3 inclusion and 0 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 10 Apr 2014. 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 Chile. 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?
Hospital-Acquired Infections (HAI) incidence density / 1,000 patient-days (time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days). 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 10 Apr 2014.