BacLite Rapid MRSA Clinical Performance | NCT00541632

Studies
BacLite Rapid MRSA Clinical Performance

NCT00541632

Sponsor

Solventum US LLC

Status

Terminated

Last Update Posted

Dec 2, 2024Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Methicillin Resistance

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

Nov 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

performance variability

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Oct 6, 2007

First Submission Date that Met QC Criteria

Oct 6, 2007

First Posted Date

Oct 10, 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

Nov 27, 2024

Last Update Posted Date

Dec 2, 2024Actual

Name	Class
3M	INDUSTRY

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

The purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA test system to traditional culture methods in detecting the presence of Methicillin Resistant Staphylococcus aureus (MRSA) directly from nasal samples.

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

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects 18 years or older
Subjects willing to document demographic characteristics
Subjects willing to have their nose swabbed
Subjects (or legal representative) willing to sign consent and authorization forms

Exclusion Criteria:

Subjects who use Vicks Sinex Nasal spray or other nasal sprays
Subjects with prescribed nasal medical devices where collecting samples may resent more than minimal risk to subjects
Subjects having nasal prosthetics, jewelry or trauma to the nose or anything that may prevents sampling the anterior nares
Investigator believes that subject is unsuitable for inclusion.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Werner E Bischoff	Wake Forest University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Denver Health Medical Center		Denver	Colorado	80204	United States
Atlanta Institute for Medical Research, Inc.