NCT03601741

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

May 2, 2018

Last Update Submit

September 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    7 Days

Secondary Outcomes (1)

  • Rate of hospital acquired MRSA infection in patients treated by participating residents

    14 Days

Study Arms (2)

Antimicrobial Stethoscope Diaphragm Covers

ACTIVE COMPARATOR
Other: Daily Antimicrobial Stethoscope Diaphragm CoverOther: Uncovered Stethoscopes

Uncovered Stethoscopes

ACTIVE COMPARATOR
Other: Daily Antimicrobial Stethoscope Diaphragm CoverOther: Uncovered Stethoscopes

Interventions

Patients will receive package with instructions to use stethoscope cover, and are then instructed to switch in 7 days

Antimicrobial Stethoscope Diaphragm CoversUncovered Stethoscopes

Patients receive instruction to begin with no covers, and are then instructed to switch in 7 days

Antimicrobial Stethoscope Diaphragm CoversUncovered Stethoscopes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Internal Medicine Residents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

  • Marwa Moussa, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2018

First Posted

July 26, 2018

Study Start

June 8, 2018

Primary Completion

April 5, 2019

Study Completion

April 5, 2019

Last Updated

September 13, 2019

Record last verified: 2019-09

Locations