ClinicalTrials.gg
CompletedNCT01139112Updated Nov 15, 2012

Klebsiella Pneumoniae Necrotizing Fasciitis: Clinical and Microbiological Features

An observational study in Necrotizing Fasciitis, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2012-11-15.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
134
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Necrotizing Fasciitis

Browse trials for

Keywords

  • Necrotizing Fasciitis, Klebsiella Pneumoniae
03

In context

Fasciitis, Necrotizing

28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.

This study's enrollment of 134 is below the median of 152 across 16 observational studies indexed under Fasciitis, Necrotizing.

Browse Fasciitis, Necrotizing studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • none
05

Study design

Time perspective
Retrospective
Enrollment
134 participants (actual)
Biospecimen retention
Samples with dna
06

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2009, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2010
First posted
Jun 8, 2010
Start
Jul 2009
Primary completionActual
Dec 2011
CompletionActual
Dec 2011
Last update
Nov 15, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01139112
Responsible party
Sponsor
First posted
Jun 8, 2010
Start date
Jul 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Nov 15, 2012

Study contacts

Chi-Tai Fang, MD, PhD
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion