NCT01139112

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 15, 2012

Status Verified

May 1, 2012

Enrollment Period

2.4 years

First QC Date

June 7, 2010

Last Update Submit

November 14, 2012

Conditions

Necrotizing Fasciitis

Keywords

Necrotizing Fasciitis, Klebsiella Pneumoniae

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

K. pneumoniae strains stored at -80oC

MeSH Terms

Conditions

Fasciitis, Necrotizing

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal Diseases

Study Officials

  • Chi-Tai Fang, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 8, 2010

Study Start

July 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 15, 2012

Record last verified: 2012-05

Locations

TW(1)