Hospital Acquired and Community Acquired MRSA in GI Lab | NCT00577343

Studies
Hospital Acquired and Community Acquired MRSA in GI Lab

NCT00577343

Sponsor

Indiana University

Status

Withdrawn

Last Update Posted

Mar 1, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Hospital Acquired MRSA
Community Acquired MRSA

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

Feb 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study lacked funding to recruit

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Dec 19, 2007

First Submission Date that Met QC Criteria

Dec 19, 2007

First Posted Date

Dec 20, 2007Estimated

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

Feb 29, 2016

Last Update Posted Date

Mar 1, 2016Estimated

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

Hospital acquired and community acquired methicillin resistant staph aureus (MRSA) has become an important health issue for in recent years. Up to two thirds of patients that are hospitalized may be colonized with MRSA. The prevalence in the community is also on the rise and affects the young and healthy. It is unclear what the true prevalence of MRSA is in our own hospital and outpatient setting. This information would be relevant to how healthcare staff adhere to contact and universal precautions. : The purpose of this study is to determine the prevalence of MRSA in patients that have gastrointestinal endoscopy and endoscopic ultrasound.

Detailed Description

Not provided

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

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The objective of this prospective study is to identify the prevalence of MRSA in patients that use the Indiana University GI lab.		less than one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.

Subjects must provide signed written informed consent.

Exclusion Criteria:

Inability to provide written informed consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

gastrointestinal lab of oupatient and inpatients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clarian/Indiana University Hospital		Indianapolis	Indiana	46202	United States