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| Tracking Information | |||||
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| First Received Date ICMJE | August 31, 2007 | ||||
| Last Updated Date | February 4, 2009 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00524212 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | How to Improve Diagnosis in Infective Endocarditis | ||||
| Official Title ICMJE | |||||
| 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). |
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| 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:
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Other, Prospective | ||||
| Condition ICMJE | Endocarditis, Bacterial | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | Prospective, controlled, blinded study of clinical/TEE criteria of IE compare to clinical/blood test criteria of IE. | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 600 | ||||
| Estimated Completion Date | January 2009 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00524212 | ||||
| Responsible Party | Jane Byriel Knudsen, Dept. of Cardiology, Aarhus University Hospital, Skejby - Denmark | ||||
| Study ID Numbers ICMJE | 06-10-B640-A1205-22345, 20060181, SUN-2007-653 | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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