Febrile NeutropeniaPhase 4EVAMICANCT00709358
Diagnosis of Septicaemia by Detection of Microbial DNA in Blood in Severe Infections
A Phase 4 study testing Detection of microbial DNA in blood by SeptiFast® and detection of microbial DNA in blood by blood culture in people with Febrile Neutropenia and Endocarditis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary purpose is to improve and quicken the microbial diagnosis in severe infections, since only one third of the cases are documented by blood cultures and adequate anti-infective therapy in the 48 hours reduced mortality and morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia, Endocarditis, Severe Sepsis
- What is being tested?
- Detection of microbial DNA in blood by SeptiFast® and detection of microbial DNA in blood by blood culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- May 2008to Sep 2010
- Phase
- Phase 4
- 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
Who may be able to join
- Age≥ 18 years
- Written signed and dated inform consent
- First time with fever observed in a neutropenic patient
- Severe sepsis in a patient hospitalized in ICU
- Suspicion of infective endocarditis
- Microbial investigation from Monday to Friday
Who cannot join
- Not affiliated to Health Insurance (social security)
- Included in another interventional trial testing microbial DNA detection during the time "without Septifast®"
- Included in another clinical trial for which the clinician assumes that it will not be possible to prescribe an anti-infectious therapy adequately to microbial detection in the blood
- Patient previously included in the protocol
- Sepsis with a microbial diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Economic Evaluation of Rapid Detection of Bacteraemia and Fungemia by Real Time PCR for Cases of Febrile Neutropenia, Suspicion of Endocarditis and Severe Sepsis in Intensive Care Units
The primary purpose is to improve and quicken the microbial diagnosis in severe infections, since only one third of the cases are documented by blood cultures and adequate anti-infective therapy in the 48 hours reduced mortality and morbidity.
Our hypothesis is that detection of microbial DNA in blood by real time PCR may increase the number of cases diagnosed for bacteraemia or fungemia and shorten the time to positive results, which will provide information for an adequate anti-infectious therapy.
Read the detailed description
We will evaluate the advantage of adding the molecular test to the microbial investigations usually done (blood cultures and others) in cases of febrile neutropenia, suspicion of infective endocarditis and severe sepsis in intensive care units.
This is a prospective study conducted in 18 sites (7 in the Paris area and 11 all over France) which will enrolled about 2000 patients over 18 years. Sites are randomized for starting with a 6-month period performing the test or 6-month period without the test (control time with the standard of care).
Primary outcome are the number of patients with documented bacteraemia or fungemia. Secondary outcome are (1) the number of patients with an adequate anti-infective therapy and how long it happens after the diagnosis, (2) mortality, (3) new complicated infection, (4) number of investigations (microbial and non microbial) done for the etiological diagnosis, and global hospitalization costs.
The advantage of the new test will be evaluated per protocol and with an intend to treat analyses. We hypothesized that the new test will bring 15% more microbial diagnosis than the standard of care. Consequently, and according to the number of sites interested in the study, 166 to 2500 patients will be enrolled with 480 to 750 patients with febrile neutropenia, 1000 to 1500 patients with severe sepsis in Intensive Care Units (ICU). Patients with suspicion of infective endocarditis will be evaluated for the number of diagnosis of true endocarditis according to Duke Criteria, and the time to diagnosis.
Health economic evaluation will compare the costs of hospitalization, microbial investigations including the new test, other non clinical investigations and consequences on the organization.
- Conditions
- Febrile Neutropenia, Endocarditis, Severe Sepsis
- Being tested
- Detection of microbial DNA in blood by SeptiFast®, detection of microbial DNA in blood by blood culture
- Keywords
- bacteria, fungi, real time PCR, adequate antimicrobial therapy, microbial DNA, microbial diagnosis
- Medical subject headings
- Febrile Neutropenia, Endocarditis, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of microbial DNA in blood by SeptiFast®Other
The LightCycler® SeptiFast Test, the innovative real-time PCR test from Roche Diagnostics, is designed to detect and identify the 25 most important bacterial and fungal species causing bloodstream infections within just a few hours. The LightCycler® SeptiFast Test detects the pathogenic bacteria and fungi directly from whole blood without the need for prior incubation or culture steps.
Rapid detection and identification of bacterial and fungal DNA, directly from a 1.5 ml whole blood sample, without prior incubation or culture steps in less than 6 hours.
detection of microbial DNA in blood by blood cultureOther
A blood culture is a test to find an infection in the blood. Most bacteria can be seen in the culture in 2 to 3 days, but some types can take 10 days or longer to show up. Fungus can take up to 30 days to show up in the culture.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Detection by blood culture Receives: Other: detection of microbial DNA in blood by blood culture |
| 1 | Experimental | Test LightCycler SeptiFast® (Roche) Receives: Other: Detection of microbial DNA in blood by SeptiFast® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bacteraemia and of fungemia - overall - each condition
Measured: max Day 30
Secondary outcomes (9)
Number of patients with adequate anti-infective therapy
Measured: at day 30
Adequate anti-infective therapy
Measured: at 24h, 48h, > 48h
Time between sampling for microbial investigation and positive results relevant for the diagnosis
Measured: between sampling for microbial investigation and positive results
Mortality
Measured: at Day 30
Sepsis chock, secondary infectious focus
Measured: at Day 30
For neutropenia cases, number of patients who evaluated with a clinical focus of infection
Measured: at day 30
Diagnosis of endocarditis
Measured: at Day 45
Number of non clinical investigations (microbial and non microbial)
Measured: at day 30
Length of hospital stay
Measured: at day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Emmanuelle CAMBAU, PH, Principal investigator, Assistance Publique - Hôpitaux de ParisRené COURCOL, PH, Principal investigator, CHRU LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709358
- Sponsor's protocol ID
- P070308
- Acronym
- EVAMICA
- Status last verified
- May 2011
- First submitted
- 2 Jul 2008
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cambau E, Durand-Zaleski I, Bretagne S, Brun-Buisson C, Cordonnier C, Duval X, Herwegh S, Pottecher J, Courcol R, Bastuji-Garin S; EVAMICA study team. Performance and economic evaluation of the molecular detection of pathogens for patients with severe infections: the EVAMICA open-label, cluster-randomised, interventional crossover trial. Intensive Care Med. 2017 Nov;43(11):1613-1625. doi: 10.1007/s00134-017-4766-4. Epub 2017 Apr 3.
PubMed 28374097
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Economic Evaluation of Rapid Detection of Bacteraemia and Fungemia by Real Time PCR for Cases of Febrile Neutropenia, Suspicion of Endocarditis and Severe Sepsis in Intensive Care Units
- ClinicalTrials.gov ID
- NCT00709358
- Acronym / sponsor ID
- EVAMICA / P070308
- Conditions
- Febrile Neutropenia, Endocarditis, Severe Sepsis
- Keywords
- bacteria, fungi, real time PCR, adequate antimicrobial therapy, microbial DNA, microbial diagnosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- May 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 3 Jul 2008 (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 primary purpose is to improve and quicken the microbial diagnosis in severe infections, since only one third of the cases are documented by blood cultures and adequate anti-infective therapy in the 48 hours reduced mortality and morbidity.
Our hypothesis is that detection of microbial DNA in blood by real time PCR may increase the number of cases diagnosed for bacteraemia or fungemia and shorten the time to positive results, which will provide information for an adequate anti-infectious therapy.
Detailed description
We will evaluate the advantage of adding the molecular test to the microbial investigations usually done (blood cultures and others) in cases of febrile neutropenia, suspicion of infective endocarditis and severe sepsis in intensive care units.
This is a prospective study conducted in 18 sites (7 in the Paris area and 11 all over France) which will enrolled about 2000 patients over 18 years. Sites are randomized for starting with a 6-month period performing the test or 6-month period without the test (control time with the standard of care).
Primary outcome are the number of patients with documented bacteraemia or fungemia. Secondary outcome are (1) the number of patients with an adequate anti-infective therapy and how long it happens after the diagnosis, (2) mortality, (3) new complicated infection, (4) number of investigations (microbial and non microbial) done for the etiological diagnosis, and global hospitalization costs.
The advantage of the new test will be evaluated per protocol and with an intend to treat analyses. We hypothesized that the new test will bring 15% more microbial diagnosis than the standard of care. Consequently, and according to the number of sites interested in the study, 166 to 2500 patients will be enrolled with 480 to 750 patients with febrile neutropenia, 1000 to 1500 patients with severe sepsis in Intensive Care Units (ICU). Patients with suspicion of infective endocarditis will be evaluated for the number of diagnosis of true endocarditis according to Duke Criteria, and the time to diagnosis.
Health economic evaluation will compare the costs of hospitalization, microbial investigations including the new test, other non clinical investigations and consequences on the organization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Other: detection of microbial DNA in blood by blood cultureDetection by blood culture |
| 1 | Experimental | Other: Detection of microbial DNA in blood by SeptiFast®Test LightCycler SeptiFast® (Roche) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥ 18 years
- Written signed and dated inform consent
- First time with fever observed in a neutropenic patient
- Severe sepsis in a patient hospitalized in ICU
- Suspicion of infective endocarditis
Key exclusion criteria (5 listed)
- Not affiliated to Health Insurance (social security)
- Included in another interventional trial testing microbial DNA detection during the time "without Septifast®"
- Included in another clinical trial for which the clinician assumes that it will not be possible to prescribe an anti-infectious therapy adequately to microbial detection in the blood
- Patient previously included in the protocol
- Sepsis with a microbial diagnosis
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 |
|---|---|---|
| Detection of microbial DNA in blood by SeptiFast®The LightCycler® SeptiFast Test, the innovative real-time PCR test from Roche Diagnostics, is designed to detect and identify the 25 most important bacterial and fungal species causing bloodstream infections within just a few hours. The LightCycler® SeptiFast Test detects the pathogenic bacteria and fungi directly from whole blood without the need for prior incubation or culture steps. Rapid detection and identification of bacterial and fungal DNA, directly from a 1.5 ml whole blood sample, without prior incubation or culture steps in less than 6 hours. | Other | 1 |
| detection of microbial DNA in blood by blood cultureA blood culture is a test to find an infection in the blood. Most bacteria can be seen in the culture in 2 to 3 days, but some types can take 10 days or longer to show up. Fungus can take up to 30 days to show up in the culture. | Other | 2 |
Primary outcome
Number of bacteraemia and of fungemia - overall - each condition
Time frame: max Day 30
9 secondary outcomes
Number of patients with adequate anti-infective therapy
Time frame: at day 30
Adequate anti-infective therapy
Time frame: at 24h, 48h, > 48h
Time between sampling for microbial investigation and positive results relevant for the diagnosis
Time frame: between sampling for microbial investigation and positive results
Mortality
Time frame: at Day 30
Sepsis chock, secondary infectious focus
Time frame: at Day 30
For neutropenia cases, number of patients who evaluated with a clinical focus of infection
Time frame: at day 30
Diagnosis of endocarditis
Time frame: at Day 45
Number of non clinical investigations (microbial and non microbial)
Time frame: at day 30
Length of hospital stay
Time frame: at day 30
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 29 Dec 2011.
- Derived from this study: PubMed 28374097Cambau E, Durand-Zaleski I, Bretagne S, Brun-Buisson C, Cordonnier C, Duval X, Herwegh S, Pottecher J, Courcol R, Bastuji-Garin S; EVAMICA study team. Performance and economic evaluation of the molecular detection of pathogens for patients with severe infections: the EVAMICA open-label, cluster-randomised, interventional crossover trial. Intensive Care Med. 2017 Nov;43(11):1613-1625. doi: 10.1007/s00134-017-4766-4. Epub 2017 Apr 3.
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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.
Emmanuelle CAMBAU, PH principal investigator
Assistance Publique - Hôpitaux de Paris
René COURCOL, PH principal investigator
CHRU LILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Detection of microbial DNA in blood by SeptiFast® and detection of microbial DNA in blood by blood culture in people with Febrile Neutropenia and Endocarditis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 6 inclusion and 5 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 29 Dec 2011. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of bacteraemia and of fungemia - overall - each condition (time frame: max Day 30). 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 NCT00709358, which also lists 1 linked publication.
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 29 Dec 2011.