Klebsiella Pneumoniae Necrotizing Fasciitis: Clinical and Microbiological Features

November 14, 2012 updated by: National Taiwan University Hospital
This is a retrospective descriptive study on the clinical and microbiological features of Klebsiella Pneumoniae Necrotizing Fasciitis.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Chi-Tai Fang, MD, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 8, 2010

Study Record Updates

Last Update Posted (Estimate)

November 15, 2012

Last Update Submitted That Met QC Criteria

November 14, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201005034R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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