Klebsiella Pneumoniae Necrotizing Fasciitis: Clinical and Microbiological Features
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|ClinicalTrials.gov Identifier: NCT01139112|
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : November 15, 2012
|Condition or disease|
Background. Necrotizing fasciitis is a rapidly progressive, life-threatening infectious disease that primarily involves soft tissue. Traditionally, group A streptococcus is the major cause of this disease. In recent years, however, there are increasing case reports of necrotizing fasciitis solely caused by Klebsiella pneumoniae. There are limited data regarding clinical and microbiological features of K. pneumoniae strains causing this disease.
Methods. We plan to review the medical records of necrotizing fasciitis cases treated during 1997-2010 at National Taiwan University Hospital, and compare the clinical features of cases caused by K. pneumonia and cases caused by group A streptococcus. We also plan to retrospectively identify necrotizing fasciitis-associated K. pneumoniae strains stored at -80oC at National Taiwan University Hospital, and perform virulence-associated hypermucoviscosity phenotyping, wzy (magA locus) and rmpA genotyping, and detection of 20-kb kfu/PTS genomic region and other iron-uptake systems.
Expected Results. This study is expected to yield the following important information: (1) The prevalence of monomicrobial K. pneumoniae necrotizing fasciitis cases among all necrotizing fasciitis cases at our hospital during the study period; (2) The distinct clinical features of K. pneumoniae necrotizing fasciitis, using group A streptococcal necrotizing fasciitis as the comparison group; (3) The microbiologic characteristics of K. pneumoniae strains causing monomicrobial necrotizing fasciitis, including hypermucoviscosity phenotype, wzy (magA locus) and rmpA genotype, and the presence of iron-uptake systems.
|Study Type :||Observational|
|Actual Enrollment :||134 participants|
|Official Title:||Klebsiella Pneumoniae Necrotizing Fasciitis: Clinical and Microbiological Features|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139112
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Chi-Tai Fang, MD, PhD||National Taiwan University Hospital|