Purpose

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).


Condition
Endocarditis, Bacterial

Genetics Home Reference related topics:   Heart Diseases   Vascular Diseases  

MedlinePlus related topics:   Endocarditis  

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective

Further study details as provided by University of Aarhus:

Estimated Enrollment:   600
Study Start Date:   March 2007
Estimated Study Completion Date:   January 2009

Groups/Cohorts
A
Prospective, controlled, blinded study of clinical/TEE criteria of IE compare to clinical/blood test criteria of 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.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Incapacity
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524212

Contacts
Contact: Jane B Knudsen, Dr.     4589496241     KnudsenJB@Gmail.com    

Locations
Denmark
Department of Cardiology, Aarhus University Hospital     Recruiting
      Aarhus, Denmark, 8200
      Contact: Jane B Knudsen, Dr.     89496241     KnudsenJB@Gmail.com    

Sponsors and Collaborators
University of Aarhus

Investigators
Principal Investigator:     Jane B Knudsen, Dr.     Aarhus University Hospital, Skejby, Department of Cardiology, 8200 Aarhus N, Denmark    
Contact: Jane B Knudsen, Dr.     4589496241     KnudsenJB@Gmail.com    
Denmark
Department of Cardiology, Aarhus University Hospital     Recruiting
      Aarhus, Denmark, 8200
      Contact: Jane B Knudsen, Dr.     89496241     KnudsenJB@Gmail.com    
University of Aarhus
Principal Investigator:     Jane B Knudsen, Dr.     Aarhus University Hospital, Skejby, Department of Cardiology, 8200 Aarhus N, Denmark    
  More Information

Study ID Numbers:   06-10-B640-A1205-22345, 20060181, SUN-2007-653
First Received:   August 31, 2007
Last Updated:   June 13, 2008
ClinicalTrials.gov Identifier:   NCT00524212
Health Authority:   Denmark: Ethics Committee;   Denmark: Danish Dataprotection Agency

Study placed in the following topic categories:
Bacterial Infections
Mycoses
Heart Diseases
Endocarditis, Bacterial
Endocarditis, infective
Infective endocarditis
Bacterial endocarditis
Endocarditis

Additional relevant MeSH terms:
Bacterial Infections and Mycoses
Cardiovascular Diseases
Cardiovascular Infections
Infection
Endocarditis, Bacterial

Source: National Library of Medicine (NLM) June 26, 2008

  
 
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