Relationship of Staphylococcal Colonization to Infection - Full Text View

Sponsored by:	Veterans BioMedical Research Institute
Information provided by:	Veterans BioMedical Research Institute
ClinicalTrials.gov Identifier:	NCT00766259

Purpose

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.

Condition
MRSA Infection

Drug Information available for: Methicillin Methicillin sodium

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Relationship of Staphylococcal Colonization to Infection

Further study details as provided by Veterans BioMedical Research Institute:

Primary Outcome Measures:

Percent of infection strains which were also colonizer earlier [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of strain colonization among co-morbidity cohorts [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

only bacterial strains collected

Estimated Enrollment:	4400
Study Start Date:	July 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

all patients admited

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

All others

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Veterans BioMedical Research Institute ( Kristen Bourgerie Executive Director )
Study ID Numbers:	Eng-MRSA
Study First Received:	October 2, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00766259
Health Authority:	United States: Institutional Review Board

Keywords provided by Veterans BioMedical Research Institute:

methicillin-resistant Staphylococcus
colonization

Study placed in the following topic categories:

Methicillin

Additional relevant MeSH terms:

Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009