BacteremiaUniEndoNCT03153384
Impact of the Blood Culture Technique on the Diagnosis of Infective Endocarditis
An observational study of Bacteremia and Infective Endocarditis, run by Central Hospital, Nancy, France at 8 sites in France.
Trial summary
To evaluate the performance of a single high volume blood culture sampling strategy versus the actually used multiple sampling strategy for the diagnosis and categorization of infective endocarditis according to the Duke-Li classification in a Population of adults suspected of infective endocarditis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia, Infective Endocarditis
- What is being tested?
- Blood Culture
- Type of treatment
- Surgery or procedure
- How many people
- 269 participants
- Where
- 8 sitesFrance
- Study dates
- 11 Nov 2017to 8 Jul 2022
- How long will I take part?
- 6 Weeks
- 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: Hospitalized adult patients suspected of infective endocarditis
Who may be able to join
- Patients older than 18 years
- Suspected endocarditis: Patients with Duke-Li-ESC 2015 classification as a major morphological criterion or at least two minor criteria, other than a microbiological criterion, will be considered suspicious of infectious endocarditis.
- Not objecting to their inclusion in the study after delivery and explanation of the information form.
- Absence of microbiological documentation sought or available at the time of inclusion (a patient having already had negative blood cultures or being identified during the screening can be included).
Who cannot join
- Antibiotherapy adapted to a situation of endocarditis, introduced more than 24 hours or stopped for less than 7 days in case of therapeutic window.
- Any previous antibiotic therapy in the 7 days preceding the inclusion leading to an improvement in the clinical symptomatology.
- State of consciousness not allowing loyal information.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Hôpital Nord Franche Comté
Belfort, 90000
Centre Hospitalier universitaire de Besançon
Besançon, 25000
Centre Hospitalier universitaire de Dijon
Dijon, 25000
Centre hospitalier Universitaire de Nancy
Nancy, 54511
Hopital BIchat Claude Bernard
Paris, 75018
Centre Hospitalier Universitaire de Reims
Reims, 51100
Centre Hospitalier Univesitaire de Rennes
Rennes, 35000
Hôpitaux Civils de Strasbourg
Strasbourg, 67000
About this study
Official title: Impact of the Blood Culture Technique on the Diagnosis of Infectious Diseases: Case of Infective Endocarditis.
To evaluate the performance of a single high volume blood culture sampling strategy versus the actually used multiple sampling strategy for the diagnosis and categorization of infective endocarditis according to the Duke-Li classification in a Population of adults suspected of infective endocarditis.
- Conditions
- Bacteremia, Infective Endocarditis
- Being tested
- Blood Culture
- Keywords
- Diagnosis, Blood Culture
- Medical subject headings
- Bacteremia, Endocarditis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood CultureProcedure or surgery
For each patient, one single high volume blood culture (3 aerobic and 3 anaerobic of 8 to 10 mL each, numbered), and then 2 samples of 16 to 20 mL (one aerobic bottle and one anaerobic for each sample).
| Study group | Role | What they receive |
|---|---|---|
| one both experimental and control arm | Each patient experiences two methods of blood cultures. Receives: Procedure: Blood Culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared performance of a single high volume blood culture vs. multiple blood culture of usual volume for the diagnosis of infective endocarditis
Sensitivity/Specificity/Accuracy of positive bloodculture sets vs. final diagnosis assessed by the medical team (gold standard)
Measured: At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion
Secondary outcomes (3)
Diagnostic performance of the single high volume blood culture for the diagnosis of infective endocarditis
according to the level of suspicion of infective endocarditis, the type of microorganism involved, the underlying cardiopathy.
Measured: At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion
Measuring the nursing time required for both sampling methods.
Time for blood culture setting, processing and sending
Measured: At T0, i.e. at the inclusion of the patient
Diagnosis of infective endocarditis: confirmed, possible or excluded
Applying the Classification of Duke-Li according to the modified diagnostic criteria of the European Society of Cardiology Recommendations 2015.
Measured: At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start11 Nov 2017
- Primary completion5 May 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 269 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GOEHRINGER François, Central Hospital, Nancy, France
- Investigators
- François Goehringer, MD, Principal investigator, Centre Hospitalier Universitaire de Nancy, Nancy, FranceXavier Duval, MD PhD, Study chair, APHP, Hôpital Bichat Claude Bernard, Paris, France.Christine Selton-Suty, MD, Study chair, Centre Hospitalier Universitaire de Nancy, Nancy, FranceNejla Aissa, MD, Study chair, Centre Hospitalier Universitaire de Nancy, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153384
- Sponsor's protocol ID
- APJ2015/UNIENDO-GOEHRINGER/SKJ
- Acronym
- UniEndo
- Status last verified
- Mar 2024
- First submitted
- 5 May 2017
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arendrup M, Jensen IP, Justesen T. Diagnosing bacteremia at a Danish hospital using one early large blood volume for culture. Scand J Infect Dis. 1996;28(6):609-14. doi: 10.3109/00365549609037969.
PubMed 9060065Dargere S, Parienti JJ, Roupie E, Gancel PE, Wiel E, Smaiti N, Loiez C, Joly LM, Lemee L, Pestel-Caron M, du Cheyron D, Verdon R, Leclercq R, Cattoir V; UBC study group. Unique blood culture for diagnosis of bloodstream infections in emergency departments: a prospective multicentre study. Clin Microbiol Infect. 2014 Nov;20(11):O920-7. doi: 10.1111/1469-0691.12656. Epub 2014 Jun 14.
PubMed 24766148The 2015 ESC Guidelines for the management of infective endocarditis. Eur Heart J. 2015 Nov 21;36(44):3036-7. doi: 10.1093/eurheartj/ehv488.
PubMed 26590409Li JS, Sexton DJ, Mick N, Nettles R, Fowler VG Jr, Ryan T, Bashore T, Corey GR. Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis. Clin Infect Dis. 2000 Apr;30(4):633-8. doi: 10.1086/313753. Epub 2000 Apr 3.
PubMed 10770721
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Blood Culture Technique on the Diagnosis of Infectious Diseases: Case of Infective Endocarditis.
- ClinicalTrials.gov ID
- NCT03153384
- Acronym / sponsor ID
- UniEndo / APJ2015/UNIENDO-GOEHRINGER/SKJ
- Conditions
- Bacteremia, Infective Endocarditis
- Keywords
- Diagnosis, Blood Culture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 15 May 2017 (actual)
- 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.
To evaluate the performance of a single high volume blood culture sampling strategy versus the actually used multiple sampling strategy for the diagnosis and categorization of infective endocarditis according to the Duke-Li classification in a Population of adults suspected of infective endocarditis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one both experimental and control arm | – | Procedure: Blood CultureEach patient experiences two methods of blood cultures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adult patients suspected of infective endocarditis
Key inclusion criteria (4 listed)
- Patients older than 18 years
- Suspected endocarditis: Patients with Duke-Li-ESC 2015 classification as a major morphological criterion or at least two minor criteria, other than a microbiological criterion, will be considered suspicious of infectious endocarditis.
- Not objecting to their inclusion in the study after delivery and explanation of the information form.
- Absence of microbiological documentation sought or available at the time of inclusion (a patient having already had negative blood cultures or being identified during the screening can be included).
Key exclusion criteria (3 listed)
- Antibiotherapy adapted to a situation of endocarditis, introduced more than 24 hours or stopped for less than 7 days in case of therapeutic window.
- Any previous antibiotic therapy in the 7 days preceding the inclusion leading to an improvement in the clinical symptomatology.
- State of consciousness not allowing loyal information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood CultureFor each patient, one single high volume blood culture (3 aerobic and 3 anaerobic of 8 to 10 mL each, numbered), and then 2 samples of 16 to 20 mL (one aerobic bottle and one anaerobic for each sample). | Procedure or surgery | one both experimental and control arm |
Primary outcome
Compared performance of a single high volume blood culture vs. multiple blood culture of usual volume for the diagnosis of infective endocarditis
Time frame: At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion
Sensitivity/Specificity/Accuracy of positive bloodculture sets vs. final diagnosis assessed by the medical team (gold standard)
3 secondary outcomes
Diagnostic performance of the single high volume blood culture for the diagnosis of infective endocarditis
Time frame: At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion
Measuring the nursing time required for both sampling methods.
Time frame: At T0, i.e. at the inclusion of the patient
Diagnosis of infective endocarditis: confirmed, possible or excluded
Time frame: At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion
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 19 Mar 2024.
- Background: PubMed 9060065Arendrup M, Jensen IP, Justesen T. Diagnosing bacteremia at a Danish hospital using one early large blood volume for culture. Scand J Infect Dis. 1996;28(6):609-14. doi: 10.3109/00365549609037969.
- Background: PubMed 24766148Dargere S, Parienti JJ, Roupie E, Gancel PE, Wiel E, Smaiti N, Loiez C, Joly LM, Lemee L, Pestel-Caron M, du Cheyron D, Verdon R, Leclercq R, Cattoir V; UBC study group. Unique blood culture for diagnosis of bloodstream infections in emergency departments: a prospective multicentre study. Clin Microbiol Infect. 2014 Nov;20(11):O920-7. doi: 10.1111/1469-0691.12656. Epub 2014 Jun 14.
- Background: PubMed 26590409The 2015 ESC Guidelines for the management of infective endocarditis. Eur Heart J. 2015 Nov 21;36(44):3036-7. doi: 10.1093/eurheartj/ehv488.
- Background: PubMed 10770721Li JS, Sexton DJ, Mick N, Nettles R, Fowler VG Jr, Ryan T, Bashore T, Corey GR. Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis. Clin Infect Dis. 2000 Apr;30(4):633-8. doi: 10.1086/313753. Epub 2000 Apr 3.
- Individual participant dataSharing planned: No
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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.
François Goehringer, MD principal investigator
Centre Hospitalier Universitaire de Nancy, Nancy, France
Xavier Duval, MD PhD study chair
APHP, Hôpital Bichat Claude Bernard, Paris, France.
Christine Selton-Suty, MD study chair
Centre Hospitalier Universitaire de Nancy, Nancy, France
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia and Infective Endocarditis, run by Central Hospital, Nancy, France at 8 sites in France.
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 4 inclusion and 3 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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.
What does the primary outcome measure?
Compared performance of a single high volume blood culture vs. multiple blood culture of usual volume for the diagnosis of infective endocarditis (time frame: At the end of the hospitalization, or at the time of death if occurred during hospitalization; i.e. an average of 6 weeks after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153384, which also lists 4 linked publications.
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 19 Mar 2024.