Relationship of Staphylococcal Colonization to Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Veterans BioMedical Research Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Veterans BioMedical Research Institute
ClinicalTrials.gov Identifier:
NCT00766259
First received: October 2, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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

  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
MRSA Infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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

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:

  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

  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
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on October 23, 2014