Coagulation and Fibrinolysis as Virulence Factors for Inv... | NCT01731483

Studies
Coagulation and Fibrinolysis as Virulence Factors for Invasive Staphylococcus Aureus and Streptococcus Infections

NCT01731483

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Sep 5, 2023Actual

Enrollment

89Actual

Phase

Not provided

Conditions

Infective Endocarditis
Necrotizing Fasciitis

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Mar 2020Actual

Completion Date

Mar 18, 2020Actual

First Submitted Date

Nov 15, 2012

First Submission Date that Met QC Criteria

Nov 20, 2012

First Posted Date

Nov 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2023

Last Update Posted Date

Sep 5, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Verhamme, Prof. Verhamme, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

89Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
proteolytic activity		1 day (on date of surgery (tissue sample))

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Verhamme, MD,PhD	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven University Hospital		Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D004696	Endocarditis
D019115	Fasciitis, Necrotizing

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D005208	Fasciitis
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided