Primary Care Management of Community-Acquired, Methicilli... | NCT00996112

Studies
Primary Care Management of Community-Acquired, Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections

NCT00996112

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Jan 25, 2013Estimated

Enrollment

4,518Actual

Phase

Not provided

Conditions

Methicillin-Resistant Staphylococcus Aureus

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

ID	Type	Description	Link
AHRQ 04-109-6314

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

May 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Oct 15, 2009

First Submission Date that Met QC Criteria

Oct 15, 2009

First Posted Date

Oct 16, 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

Jan 23, 2013

Last Update Posted Date

Jan 25, 2013Estimated

Name	Class
American Academy of Family Physicians National Research Network	NETWORK

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 goal of this study is to further the investigators' understanding of community acquired methicillin-resistant Staph Aureus (CA-MRSA) and treatment of it by developing real-world sustainable strategies consistent with existing guidelines on treatment of CA-MRSA from the Centers for Disease Control and Prevention (CDC) and test these strategies in busy primary care settings.

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

4,518Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physician Behavior Change	Intervention in practice for guideline-concordant care of CA MRSA	Throughout study participation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients presenting at a primary care clinic who have a skin or soft tissue infection.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

89 Years

Standard Ages

ChildAdultOlder Adult

Study Population

The study population comprises primary care patients in ambulatory clinics from two health care systems.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David R West, PhD	Department of Family Medicine, University of Colorado Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Denver		Aurora	Colorado	80045	United States

Label	Type	Description	Intervention Names
Historical
Prospective