Relationship of Staphylococcal Colonization to Infection | NCT00766259

Studies
Relationship of Staphylococcal Colonization to Infection

NCT00766259

Sponsor

Veterans BioMedical Research Institute

Status

Withdrawn

Last Update Posted

May 3, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

MRSA Infection

Interventions

Not provided

Countries

Not provided

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

poor accrual

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jun 2011Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Oct 2, 2008

First Submission Date that Met QC Criteria

Oct 2, 2008

First Posted Date

Oct 3, 2008Estimated

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

May 1, 2024

Last Update Posted Date

May 3, 2024Actual

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

Inpatients will be prospectively have nares screened and MRSA strains collected. All clinical MRSA strains of patients will also be prospectively collected. A sensitive strain discrimination test of spa typing will be used to determine if the strains are related. Hypotheses are

Strain colonization durations vary and may be very short in days to weeks.
Colonizing strains rarely infect 3) Both 1 and 2 may be affected by the patient's co-morbidity.

Detailed Description

Patients of special interest:

Skin and soft tissue infection
Nursing home patients
Vascular patients with leg lesions
ICU patients
Hemodialysis patients
Outpatients without history of infections(controls) will have nares screened for MRSA and then monthly for 1 year.

All strains will be saved and spa typed. Analysis of the data will be performed to answer the questions and hypotheses and to answer is the screening effort and the isolation of patients for MRSA as is in current practice worthwhile and is there any scientific data to support this practice

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Hemodialysis
2		Intensive care
3		vascular patients with open wounds
4		nursing home
5		skin infections
6		control- ambulatory care clinic patients with no infections

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of infection strains which were also colonizer earlier		3 years

Secondary Outcomes

Measure	Description	Time Frame
Duration of strain colonization among co-morbidity cohorts		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted and one of the co-morbid groups
Ambulatory care patient with no infections

Exclusion Criteria:

All others

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all patients admited

Sampling Method

Non-Probability Sample