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An Evaluation Of Respiratory Samples for Staphylococcus Resistance PatternsS (MRSA)
This study has been completed.
Sponsor:
University of Kentucky
Collaborator:
Pfizer
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00754273
First received: September 16, 2008
Last updated: March 22, 2011
Last verified: March 2011
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Purpose
To determine the prevalence of MRSA isolates with marginal susceptibility to vancomycin or heteroresistance.
| Condition | Intervention |
|---|---|
| Methicillin-resistant Staphylococcal Aureus Pneumonia | Other: etest susceptability testing |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Prospective Evaluation Of Protected Alveolar Lavage (PAL) Staphylococcus Aurues Resistance Patterns |
Resource links provided by NLM:
Further study details as provided by University of Kentucky:
Primary Outcome Measures:
- Determine the prevalence of PAL hetero-VISA within MRSA isolates using vancomycin E-tests and contrast this with E-tests for teicoplanin, linezolid and tigecycline. [ Time Frame: 1 time ]
Secondary Outcome Measures:
- Determine the sensitivity and specificity of automated susceptibility testing for PAL MRSA for vancomycin and alternative agents teicoplanin, linezolid and tigecycline by comparing automated sensitivity testing to E-test results. [ Time Frame: 1 time ]
| Estimated Enrollment: | 1250 |
| Study Start Date: | September 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
PAL samples collected for pneumonia evaluation
|
Other: etest susceptability testing
E-test methodology is performed on all MRSA samples using standardized inoculum (0.5 McFarland) for Tigecycline, Vancomycin, Teicoplanin, and Linezolid. E test is performed using heavy inoculum for Vancomycin and Teicoplanin (2.0 McFarland).
|
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Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
One hundred consecutive isolates of MRSA will be analyzed.
Criteria
Inclusion Criteria:
- Isolates of MRSA from PAL samples
Exclusion Criteria:
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754273
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754273
Locations
| United States, Kentucky | |
| University of Kentucky Medical Center | |
| Lexington, Kentucky, United States, 40536 | |
Sponsors and Collaborators
University of Kentucky
Pfizer
Investigators
| Principal Investigator: | Andrew C. Bernard, M.D. | University of Kentucky |
More Information
| Responsible Party: | Andrew Bernard, M.D., University of Kentucky Medical Center |
| ClinicalTrials.gov Identifier: | NCT00754273 History of Changes |
| Other Study ID Numbers: |
07-0775-P6H |
| Study First Received: | September 16, 2008 |
| Last Updated: | March 22, 2011 |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on August 22, 2017