NCT00524212

Brief Summary

The purpose is to exam prospective if simple clinical information in combination with a normal s-procalcitonin are sufficient for exclusion of infective endocarditis (IE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
761

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

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

March 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

First QC Date

August 31, 2007

Last Update Submit

January 19, 2010

Conditions

Endocarditis, Bacterial

Study Arms (2)

IE confirmed IE rejected

Prospective, controlled, blinded study of clinical/TEE criteria of IE compare to clinical/blood test criteria of IE.

IE confirmed IE rejected

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The cohort was selected from all the patients admitted to the tertiary hospital (the initial diagnosis was infective endocarditis)

You may qualify if:

  • Patients \> or = 18 year with suspected or verified Infective Endocarditis
  • By word of mouth or in writing consent

You may not qualify if:

  • Incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A venous blood sample was obtained from each patients and all samples were centrifuged and immediately frozen.

MeSH Terms

Conditions

Endocarditis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsCardiovascular InfectionsCardiovascular DiseasesEndocarditisHeart Diseases

Study Officials

  • Jane B Knudsen, Dr.

    Aarhus University Hospital, Skejby, Department of Cardiology, 8200 Aarhus N, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 3, 2007

Study Start

March 1, 2007

Study Completion

May 1, 2009

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

DK(1)