Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

How to Improve Diagnosis in Infective Endocarditis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00524212
Recruitment Status : Completed
First Posted : September 3, 2007
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date August 31, 2007
First Posted Date September 3, 2007
Last Update Posted Date January 20, 2010
Study Start Date March 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title How to Improve Diagnosis in Infective Endocarditis
Official Title Ph. D Student, Jane Byriel Knudsen, Aarhus University
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).
Detailed Description

Despite progress in surgical and medical treatment, infective endocarditis is still associated with high morbidity and mortality.

The variable clinical presentation of IE makes the diagnosis a clinical challenge.

Procalcitonin is a precursor from the hormone calcitonin and also a marker of systemic bacterial infections.

The purpose of this study is:

  • to investigate the diagnostic value of serum procalcitonin (PCT), C-reactive protein (CRP) and sedimentation rate (SR) when IE is suspected.
  • to investigate if a retrospectively generated clinical model suitable for exclusion of IE can be confirmed prospectively.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
A venous blood sample was obtained from each patients and all samples were centrifuged and immediately frozen.
Sampling Method Probability Sample
Study Population The cohort was selected from all the patients admitted to the tertiary hospital (the initial diagnosis was infective endocarditis)
Condition Endocarditis, Bacterial
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 19, 2010)
761
Original Estimated Enrollment
 (submitted: August 31, 2007)
600
Actual Study Completion Date May 2009
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Incapacity
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00524212
Other Study ID Numbers 06-10-B640-A1205-22345
20060181
SUN-2007-653
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jane Byriel Knudsen, Dept. of Cardiology, Aarhus University Hospital, Skejby - Denmark
Study Sponsor University of Aarhus
Collaborators Not Provided
Investigators
Principal Investigator: Jane B Knudsen, Dr. Aarhus University Hospital, Skejby, Department of Cardiology, 8200 Aarhus N, Denmark
PRS Account University of Aarhus
Verification Date January 2010