NCT01731483

Brief Summary

the aim of this study is to investigate the role of staphylokinase, streptokinase and MMP activation in invasive staphylococcal and streptococcal infections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 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, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

7.7 years

First QC Date

November 15, 2012

Last Update Submit

September 1, 2023

Conditions

Infective EndocarditisNecrotizing Fasciitis

Keywords

virulence factors

Outcome Measures

Primary Outcomes (1)

  • proteolytic activity

    1 day (on date of surgery (tissue sample))

Eligibility Criteria

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

Material will be collected from all patients that undergo surgical treatment for invasive streptococcal or staphylococcal infections, including acute infective endocarditis and necrotizing fasciitis, from the UZ Leuven University Hospital

You may qualify if:

  • all patients that undergo surgical treatment for invasive streptococcal or staphylococcal infections, including acute infective endocarditis and necrotizing fasciitis, from the UZ Leuven University Hospital

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven University Hospital

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

tissue specimens from endocarditis lesions and necrotizing fasciitis

MeSH Terms

Conditions

EndocarditisFasciitis, Necrotizing

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesFasciitisMusculoskeletal Diseases

Study Officials

  • Peter Verhamme, MD,PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Verhamme

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2020

Study Completion

March 18, 2020

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

BE(1)