Incidence of Methicillin Resistant Staphylococcus Aureus... | NCT00929435

Studies
Incidence of Methicillin Resistant Staphylococcus Aureus (MRSA) Carriage Rates in Resident Physicians

NCT00929435

Sponsor

University of Oklahoma

Status

Terminated

Last Update Posted

Apr 9, 2012Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

MRSA Colonization

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Minimal enrollment

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jun 24, 2009

First Submission Date that Met QC Criteria

Jun 25, 2009

First Posted Date

Jun 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2012

Last Update Posted Date

Apr 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

One hundred new residents will be recruited prior to the start of residency and followed prospectively for a year. Monthly nasal swabs will be performed to identify colonization with methicillin resistant staphylococcus aureus (MRSA).The proportion of study subjects colonized with MRSA at the end of 1 year will be calculated.

Detailed Description

This is a prospective observational study looking at the incidence of MRSA colonization. New residents will be monitored every month with nasal swabs.We would like to elucidate factors responsible for MRSA colonization in healthcare workers.We would like to see if health care workers who are colonized spontaneously cleared MRSA and if there was any factors involved.

Nasal swabs will be plated on the spot by trained individuals and the plates then incubated for 48 hours. Plates will be read by microbiologist after incubation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRSA surveillance		Newly recruited resident physicians will be monitored for a year with nasal swabs monthly.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To detect an increase in MRSA nasal carriage rate among newly appointed residents after 1 year of regular patient contact.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Study subjects will be newly appointed residents at the OU medical center

Exclusion Criteria:

Previous MRSA infection
Current use of mupirocin

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

All newly recruited residents will be eligible for enrollment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gary T Kinasewitz, MD	University of Oklahoma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oklahoma University health science center		Oklahoma City	Oklahoma	73104	United States