Endocarditis, BacterialNCT00524212
How to Improve Diagnosis in Infective Endocarditis
An observational study of Endocarditis, Bacterial, run by University of Aarhus at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis, Bacterial
- How many people
- 761 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort was selected from all the patients admitted to the tertiary hospital (the initial diagnosis was infective endocarditis)
Who may be able to join
- Patients > or = 18 year with suspected or verified Infective Endocarditis
- By word of mouth or in writing consent
Who cannot join
- Incapacity
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Aarhus University Hospital
Aarhus, 8200
About this study
Official title: Ph. D Student, Jane Byriel Knudsen, Aarhus University
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).
Read the 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.
- Conditions
- Endocarditis, Bacterial
- Medical subject headings
- Endocarditis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startMar 2007
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocarditis, BacterialStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Jane B Knudsen, Dr., Principal investigator, Aarhus University Hospital, Skejby, Department of Cardiology, 8200 Aarhus N, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524212
- Sponsor's protocol ID
- 06-10-B640-A1205-22345
- Other IDs
- 20060181, SUN-2007-653
- Status last verified
- Jan 2010
- First submitted
- 31 Aug 2007
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph. D Student, Jane Byriel Knudsen, Aarhus University
- ClinicalTrials.gov ID
- NCT00524212
- Acronym / sponsor ID
- 06-10-B640-A1205-22345
- Conditions
- Endocarditis, Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- May 2009 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort was selected from all the patients admitted to the tertiary hospital (the initial diagnosis was infective endocarditis)
Key inclusion criteria (2 listed)
- Patients > or = 18 year with suspected or verified Infective Endocarditis
- By word of mouth or in writing consent
Key exclusion criteria (1 listed)
- Incapacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane B Knudsen, Dr. principal investigator
Aarhus University Hospital, Skejby, Department of Cardiology, 8200 Aarhus N, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocarditis, Bacterial, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010.