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Diagnosis of Septicaemia by Detection of Microbial DNA in Blood in Severe Infections (EVAMICA)

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ClinicalTrials.gov Identifier: NCT00709358
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : December 29, 2011
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE July 2, 2008
First Posted Date  ICMJE July 3, 2008
Last Update Posted Date December 29, 2011
Study Start Date  ICMJE May 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2008)
Number of bacteraemia and of fungemia - overall - each condition [ Time Frame: max Day 30 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2008)
  • 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: during study ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnosis of Septicaemia by Detection of Microbial DNA in Blood in Severe Infections
Official Title  ICMJE 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
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Febrile Neutropenia
  • Endocarditis
  • Severe Sepsis
Intervention  ICMJE
  • Other: 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: detection of microbial DNA in blood by blood culture
    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 Arms  ICMJE
  • Active Comparator: 2
    Detection by blood culture
    Intervention: Other: detection of microbial DNA in blood by blood culture
  • Experimental: 1
    Test LightCycler SeptiFast® (Roche)
    Intervention: Other: Detection of microbial DNA in blood by SeptiFast®
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2008)
2000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00709358
Other Study ID Numbers  ICMJE P070308
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Principal Investigator: Emmanuelle CAMBAU, PH Assistance Publique - Hôpitaux de Paris
Principal Investigator: René COURCOL, PH CHRU LILLE
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP