ClinicalTrials.gov
ClinicalTrials.gov Menu

Relationship of Staphylococcal Colonization to Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00766259
Recruitment Status : Unknown
Verified October 2008 by Veterans BioMedical Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : October 3, 2008
Last Update Posted : October 3, 2008
Sponsor:
Information provided by:
Veterans BioMedical Research Institute

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

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

Condition or disease
MRSA Infection

Detailed Description:

Patients of special interest:

  1. Skin and soft tissue infection
  2. Nursing home patients
  3. Vascular patients with leg lesions
  4. ICU patients
  5. Hemodialysis patients
  6. 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


Study Type : Observational
Estimated Enrollment : 4400 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Relationship of Staphylococcal Colonization to Infection
Study Start Date : July 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2012

Group/Cohort
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



Primary Outcome Measures :
  1. Percent of infection strains which were also colonizer earlier [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Duration of strain colonization among co-morbidity cohorts [ Time Frame: 3 years ]

Biospecimen Retention:   None Retained
only bacterial strains collected


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Responsible Party: Kristen Bourgerie Executive Director, Veterans BioMedical Research Institute
ClinicalTrials.gov Identifier: NCT00766259     History of Changes
Other Study ID Numbers: Eng-MRSA
First Posted: October 3, 2008    Key Record Dates
Last Update Posted: October 3, 2008
Last Verified: October 2008

Keywords provided by Veterans BioMedical Research Institute:
methicillin-resistant Staphylococcus
colonization

Additional relevant MeSH terms:
Infection
Communicable Diseases