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Klebsiella Pneumoniae Necrotizing Fasciitis: Clinical and Microbiological Features

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01139112
First received: June 7, 2010
Last updated: November 14, 2012
Last verified: May 2012
History of Changes
  Purpose

This is a retrospective descriptive study on the clinical and microbiological features of Klebsiella Pneumoniae Necrotizing Fasciitis.


Condition
Necrotizing Fasciitis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Klebsiella Pneumoniae Necrotizing Fasciitis: Clinical and Microbiological Features

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA

K. pneumoniae strains stored at -80oC


Enrollment: 134
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

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

Necrotizing fasciitis cases treated during 1997-2010 at National Taiwan University Hospital

Criteria

Inclusion Criteria:

  • Definitive diagnosis of necrotizing fasciitis depends on intra-operative findings characterized by a lack of resistance to blunt dissection of the normally adherent fascia, presence of necrotic fascia, and purulent malodorous discharge. Pathological findings of the involved fascia typically show neutrophils and bacterial clumps infiltrating between collagen bundles of with focal necrosis.

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139112

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chi-Tai Fang, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01139112     History of Changes
Other Study ID Numbers: 201005034R
Study First Received: June 7, 2010
Last Updated: November 14, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Necrotizing Fasciitis, Klebsiella Pneumoniae

Additional relevant MeSH terms:
Pneumonia
Klebsiella Infections
Fasciitis
Fasciitis, Necrotizing
Lung Abscess
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Musculoskeletal Diseases
Skin Diseases, Bacterial
Abscess
Suppuration
Infection

ClinicalTrials.gov processed this record on May 16, 2013