Methicillin-Resistant Staphylococcus AureusNCT01671358
Comparison of Bacterial Contamination Rates Between Isolation and Non-isolation Rooms
An observational study of Methicillin-Resistant Staphylococcus Aureus, run by West Virginia University at 1 site in United States.
Trial summary
This study is to determine if medication cabinets located outside of isolation rooms in hospitals and their contents, particularly medications and the delivery folders are at a higher risk of having harmful bacteria on them. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2013
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Inaptients at an academic medical center
Who may be able to join
- Patient rooms with isolation status for MRSA
- Patient rooms without isolation status for MRSA for 14 days
Who cannot join
- Rooms without medication cabinets directly outside the room
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Hospitals
Morgantown, West Virginia, 26506
About this study
Official title: Comparison of Contamination Rates of Medication Storage Cabinets Between Isolation and Non-isolation Rooms With Methicillin-resistant Staphylococcus Aureus (MRSA)
This study is to determine if medication cabinets located outside of isolation rooms in hospitals and their contents, particularly medications and the delivery folders are at a higher risk of having harmful bacteria on them.
Read the detailed description
Studies show high touch areas maybe contaminated with organisms such as Methicillin-resistant Staphylococcus aureus(MRSA) and vancomycin-resistant enterococci. MRSA can live on hospital surfaces for 9-14 days. Patients in rooms that were previously MRSA isolation rooms are at higher risk for developing a hospital-acquired infection.
This study is to determine if medication cabinets located outside of MRSA isolation rooms and their contents, particularly medications and the pharmacy delivery folders are at a higher risk of having MRSA colonization on them. This study will use conventional methods to determine if MRSA colonization is present and compare results between non-isolation and isolation rooms. This will evaluate if alternate measures for the reduction of MRSA colonization are needed for the MRSA isolation rooms in regards to medication delivery and storage.
- Keywords
- MRSA, Contamination, Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Isolation Rooms for MRSA | Rooms that currently have a patient in them that are in isolation status due to MRSA | |
| Non-isolation rooms | Rooms that have not been occupied by a patient in isolation due to MRSA for 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of MRSA colonization
Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. Individual colonies will be removed from the plate with an inoculation loop, then streaked onto a second sheep blood agar plate. The second plates will be incubated for 48 hours. The colonies will then be run through standard identification tests to determine if the colonies are MRSA or not. A comparison will be made between non-isolation and isolation rooms.
Measured: Hospital stay, an expected average of 14 days
Secondary outcomes (1)
Quantification of MRSA colonization
Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. A comparison between the sites of swabbing will be performed.
Measured: Hospital stay, an expected average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Methicillin-Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sweet, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671358
- Sponsor's protocol ID
- WVU-00010
- Status last verified
- Jun 2015
- First submitted
- 16 Aug 2012
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bures S, Fishbain JT, Uyehara CF, Parker JM, Berg BW. Computer keyboards and faucet handles as reservoirs of nosocomial pathogens in the intensive care unit. Am J Infect Control. 2000 Dec;28(6):465-71. doi: 10.1067/mic.2000.107267.
PubMed 11114617Sexton T, Clarke P, O'Neill E, Dillane T, Humphreys H. Environmental reservoirs of methicillin-resistant Staphylococcus aureus in isolation rooms: correlation with patient isolates and implications for hospital hygiene. J Hosp Infect. 2006 Feb;62(2):187-94. doi: 10.1016/j.jhin.2005.07.017. Epub 2005 Nov 14.
PubMed 16290319Oie S, Hosokawa I, Kamiya A. Contamination of room door handles by methicillin-sensitive/methicillin-resistant Staphylococcus aureus. J Hosp Infect. 2002 Jun;51(2):140-3. doi: 10.1053/jhin.2002.1221.
PubMed 12090803Huang SS, Datta R, Platt R. Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch Intern Med. 2006 Oct 9;166(18):1945-51. doi: 10.1001/archinte.166.18.1945.
PubMed 17030826Huang R, Mehta S, Weed D, Price CS. Methicillin-resistant Staphylococcus aureus survival on hospital fomites. Infect Control Hosp Epidemiol. 2006 Nov;27(11):1267-9. doi: 10.1086/507965. Epub 2006 Sep 28.
PubMed 17080391
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Contamination Rates of Medication Storage Cabinets Between Isolation and Non-isolation Rooms With Methicillin-resistant Staphylococcus Aureus (MRSA)
- ClinicalTrials.gov ID
- NCT01671358
- Acronym / sponsor ID
- WVU-00010
- Keywords
- MRSA, Contamination, Isolation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Aug 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.
This study is to determine if medication cabinets located outside of isolation rooms in hospitals and their contents, particularly medications and the delivery folders are at a higher risk of having harmful bacteria on them.
Detailed description
Studies show high touch areas maybe contaminated with organisms such as Methicillin-resistant Staphylococcus aureus(MRSA) and vancomycin-resistant enterococci. MRSA can live on hospital surfaces for 9-14 days. Patients in rooms that were previously MRSA isolation rooms are at higher risk for developing a hospital-acquired infection.
This study is to determine if medication cabinets located outside of MRSA isolation rooms and their contents, particularly medications and the pharmacy delivery folders are at a higher risk of having MRSA colonization on them. This study will use conventional methods to determine if MRSA colonization is present and compare results between non-isolation and isolation rooms. This will evaluate if alternate measures for the reduction of MRSA colonization are needed for the MRSA isolation rooms in regards to medication delivery and storage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolation Rooms for MRSA | – | –Rooms that currently have a patient in them that are in isolation status due to MRSA |
| Non-isolation rooms | – | –Rooms that have not been occupied by a patient in isolation due to MRSA for 14 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inaptients at an academic medical center
Key inclusion criteria (2 listed)
- Patient rooms with isolation status for MRSA
- Patient rooms without isolation status for MRSA for 14 days
Key exclusion criteria (1 listed)
- Rooms without medication cabinets directly outside the room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of MRSA colonization
Time frame: Hospital stay, an expected average of 14 days
Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. Individual colonies will be removed from the plate with an inoculation loop, then streaked onto a second sheep blood agar plate. The second plates will be incubated for 48 hours. The colonies will then be run through standard identification tests to determine if the colonies are MRSA or not. A comparison will be made between non-isolation and isolation rooms.
1 secondary outcome
Quantification of MRSA colonization
Time frame: Hospital stay, an expected average of 14 days
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 2 Jun 2015.
- Background: PubMed 11114617Bures S, Fishbain JT, Uyehara CF, Parker JM, Berg BW. Computer keyboards and faucet handles as reservoirs of nosocomial pathogens in the intensive care unit. Am J Infect Control. 2000 Dec;28(6):465-71. doi: 10.1067/mic.2000.107267.
- Background: PubMed 16290319Sexton T, Clarke P, O'Neill E, Dillane T, Humphreys H. Environmental reservoirs of methicillin-resistant Staphylococcus aureus in isolation rooms: correlation with patient isolates and implications for hospital hygiene. J Hosp Infect. 2006 Feb;62(2):187-94. doi: 10.1016/j.jhin.2005.07.017. Epub 2005 Nov 14.
- Background: PubMed 12090803Oie S, Hosokawa I, Kamiya A. Contamination of room door handles by methicillin-sensitive/methicillin-resistant Staphylococcus aureus. J Hosp Infect. 2002 Jun;51(2):140-3. doi: 10.1053/jhin.2002.1221.
- Background: PubMed 17030826Huang SS, Datta R, Platt R. Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch Intern Med. 2006 Oct 9;166(18):1945-51. doi: 10.1001/archinte.166.18.1945.
- Background: PubMed 17080391Huang R, Mehta S, Weed D, Price CS. Methicillin-resistant Staphylococcus aureus survival on hospital fomites. Infect Control Hosp Epidemiol. 2006 Nov;27(11):1267-9. doi: 10.1086/507965. Epub 2006 Sep 28.
Related trials for Methicillin-Resistant Staphylococcus Aureus
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingPhase 4
Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia
Staphylococcus Aureus Septicemia, Staphylococcus Aureus Bacteremia
Not yet recruitingObservational study
Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus
Staphylococcal Aureus Infection, Surgical Site Infection (SSI)
Not yet recruitingPhase 2
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA)
RecruitingPhase 4
Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methicillin-Resistant Staphylococcus Aureus, run by West Virginia University 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 2 inclusion and 1 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 2 Jun 2015. 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?
Presence of MRSA colonization (time frame: Hospital stay, an expected average of 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01671358, which also lists 5 linked publications.
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 2 Jun 2015.