MRSANCT03601741
Use of Disposable Stethoscope Covers for Reduction of Stethoscope MRSA Contamination
A study testing Daily Antimicrobial Stethoscope Diaphragm Cover and Uncovered Stethoscopes in people with MRSA, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a prospective pilot study using a randomized, controlled, single blinded, crossover trial design, evaluating the effect of daily antimicrobial stethoscope diaphragm covers versus uncovered stethoscope. Stethoscopes will be cleaned Sani-cloth germicidal disposable wipes which are effective against MRSA. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- MRSA
- What is being tested?
- Daily Antimicrobial Stethoscope Diaphragm Cover and Uncovered Stethoscopes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2018to 5 Apr 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Internal Medicine Residents
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This is a prospective pilot study using a randomized, controlled, single blinded, crossover trial design, evaluating the effect of daily antimicrobial stethoscope diaphragm covers versus uncovered stethoscope. Stethoscopes will be cleaned Sani-cloth germicidal disposable wipes which are effective against MRSA. Each participant will then be randomly assigned to 7 days in either the intervention or the control arm. At the end of the 7 days participants stethoscopes will be cleaned again. This will be followed by another 7 days in the arm that they are not in during the first 7 days.
The primary endpoint is MRSA colony count from stethoscope diaphragms cultures at 7 days, focusing on the difference between the intervention and the control periods. The secondary endpoint is the rate of hospital acquired MRSA infection in patients treated by residents during each period.
- Conditions
- MRSA
- Being tested
- Daily Antimicrobial Stethoscope Diaphragm Cover, Uncovered Stethoscopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Antimicrobial Stethoscope Diaphragm CoverOther
Patients will receive package with instructions to use stethoscope cover, and are then instructed to switch in 7 days
Uncovered StethoscopesOther
Patients receive instruction to begin with no covers, and are then instructed to switch in 7 days
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial Stethoscope Diaphragm Covers | Active comparator | Not described Receives: Other: Daily Antimicrobial Stethoscope Diaphragm Cover; Other: Uncovered Stethoscopes |
| Uncovered Stethoscopes | Active comparator | Not described Receives: Other: Daily Antimicrobial Stethoscope Diaphragm Cover; Other: Uncovered Stethoscopes |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRSA colony count cultured from stethoscope diaphragms
Total CFU of each selected pathogen at 7 days compared by paired Mann-Whitney U tests, with each patient serving as their own control
Measured: 7 Days
Secondary outcomes (1)
Rate of hospital acquired MRSA infection in patients treated by participating residents
Rates on nosocomial infection in each arm compared through use of Kaplan Meier curves
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start8 Jun 2018
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSAStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marwa Moussa, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601741
- Sponsor's protocol ID
- 17-01633
- Status last verified
- Sep 2019
- First submitted
- 2 May 2018
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Disposable Stethoscope Covers for Reduction of Stethoscope MRSA Contamination
- ClinicalTrials.gov ID
- NCT03601741
- Acronym / sponsor ID
- 17-01633
- Conditions
- MRSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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 is a prospective pilot study using a randomized, controlled, single blinded, crossover trial design, evaluating the effect of daily antimicrobial stethoscope diaphragm covers versus uncovered stethoscope. Stethoscopes will be cleaned Sani-cloth germicidal disposable wipes which are effective against MRSA. Each participant will then be randomly assigned to 7 days in either the intervention or the control arm. At the end of the 7 days participants stethoscopes will be cleaned again. This will be followed by another 7 days in the arm that they are not in during the first 7 days.
The primary endpoint is MRSA colony count from stethoscope diaphragms cultures at 7 days, focusing on the difference between the intervention and the control periods. The secondary endpoint is the rate of hospital acquired MRSA infection in patients treated by residents during each period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial Stethoscope Diaphragm Covers | Active comparator | Other: Daily Antimicrobial Stethoscope Diaphragm Cover, Other: Uncovered Stethoscopes |
| Uncovered Stethoscopes | Active comparator | Other: Daily Antimicrobial Stethoscope Diaphragm Cover, Other: Uncovered Stethoscopes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Internal Medicine Residents
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| Daily Antimicrobial Stethoscope Diaphragm CoverPatients will receive package with instructions to use stethoscope cover, and are then instructed to switch in 7 days | Other | Antimicrobial Stethoscope Diaphragm Covers, Uncovered Stethoscopes |
| Uncovered StethoscopesPatients receive instruction to begin with no covers, and are then instructed to switch in 7 days | Other | Antimicrobial Stethoscope Diaphragm Covers, Uncovered Stethoscopes |
Primary outcome
MRSA colony count cultured from stethoscope diaphragms
Time frame: 7 Days
Total CFU of each selected pathogen at 7 days compared by paired Mann-Whitney U tests, with each patient serving as their own control
1 secondary outcome
Rate of hospital acquired MRSA infection in patients treated by participating residents
Time frame: 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 13 Sep 2019.
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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.
Marwa Moussa, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Antimicrobial Stethoscope Diaphragm Cover and Uncovered Stethoscopes in people with MRSA, run by NYU Langone Health 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 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 13 Sep 2019. 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?
MRSA colony count cultured from stethoscope diaphragms (time frame: 7 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 13 Sep 2019.