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Prospective observational cohort consisting of all adult patients admitted to participating critical care units (ICU and CCU) during the study period, with blood cultures collected as part of their care, and who did not express any objection to participating.
For each patient, data will be collected prospectively for each blood culture set collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| learning database group | The results of blood cultures and the clinical elements of the patients in the first sample (1600 patients) will constitute the learning database. A supervised learning will be performed on these data in order to select a set of clinical elements allowing to define a predictive score of positive blood cultures |
| |
| validation database group | The score will be validated on the remaining sample (800 patients), independent of the first sample. Both samples will be constituted by randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ROC curve of the predictive performance of the score for predicting bacteremia or fungemia. | day 1- day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ROC curve of the diagnostic performance of body temperature to predict bacteremia or fungemia; | day 1- day 28 | |
| Area under the ROC curve of the diagnostic performance of the Shapiro score for predicting bacteremia or fungemia; | day 1- day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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critical care patient with suspected infection.
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| Name | Affiliation | Role |
|---|---|---|
| Denis GAROT | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Brest | France | ||||
| CHU Dijon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26903335 | Background | Seymour CW, Liu VX, Iwashyna TJ, Brunkhorst FM, Rea TD, Scherag A, Rubenfeld G, Kahn JM, Shankar-Hari M, Singer M, Deutschman CS, Escobar GJ, Angus DC. Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):762-74. doi: 10.1001/jama.2016.0288. | |
| 28903154 |
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| Proportion of bacteremia or fungemia identified by blood cultures in patients on antibiotic therapy and broad-spectrum antibiotic therapy, and factors associated with these bacteremias or fungemias; | day 1- day 28 |
| Comparison of the diagnostic performance of the score in predicting bacteremia or fungemia observed during the first 48 hours of hospitalization to later bacteremias; | 48 hours |
| Descriptive study of the contribution of blood cultures, whatever their results, to the prescription of anti-infectives. | day 1- day 28 |
| Efficiency of the new predictive score for blood culture positivity in Intensive Care, as compared with body temperature and Shapiro score, measured by two Incremental Cost-Effectiveness Ratios (ICER): ICER (incremental cost per additional well-detecte | A tree decision model will compare three strategies for predicting positive blood cultures: the new predictive score, body temperature and Shapiro score. Within-trial data will be used to define the model parameters. The model will consider the costs related to the implementation of the strategies, blood cultures, and potential delays in patient management. This will result in the estimation of the two ICERs. | less than 1 month |
| Dijon |
| France |
| CHD La Roche sur Yon | La Roche-sur-Yon | France |
| CH Le Mans | Le Mans | France |
| CHU Nantes | Nantes | France |
| CHR Orléans | Orléans | France |
| CHU Poitiers | Poitiers | France |
| CHU Rennes | Rennes | France |
| CHIU Strasbourg | Strasbourg | France |
| CHU de Tours | Tours | 37044 | France |
| Rhee C, Dantes R, Epstein L, Murphy DJ, Seymour CW, Iwashyna TJ, Kadri SS, Angus DC, Danner RL, Fiore AE, Jernigan JA, Martin GS, Septimus E, Warren DK, Karcz A, Chan C, Menchaca JT, Wang R, Gruber S, Klompas M; CDC Prevention Epicenter Program. Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014. JAMA. 2017 Oct 3;318(13):1241-1249. doi: 10.1001/jama.2017.13836. |
| 23473333 | Background | Goto M, Al-Hasan MN. Overall burden of bloodstream infection and nosocomial bloodstream infection in North America and Europe. Clin Microbiol Infect. 2013 Jun;19(6):501-9. doi: 10.1111/1469-0691.12195. Epub 2013 Mar 8. |
| 29746948 | Background | McNamara JF, Righi E, Wright H, Hartel GF, Harris PNA, Paterson DL. Long-term morbidity and mortality following bloodstream infection: A systematic literature review. J Infect. 2018 Jul;77(1):1-8. doi: 10.1016/j.jinf.2018.03.005. Epub 2018 May 7. |
| 27552910 | Background | Patel R. New Developments in Clinical Bacteriology Laboratories. Mayo Clin Proc. 2016 Oct;91(10):1448-1459. doi: 10.1016/j.mayocp.2016.06.020. Epub 2016 Aug 21. |
| 21499970 | Background | Leyssene D, Gardes S, Vilquin P, Flandrois JP, Carret G, Lamy B. Species-driven interpretation guidelines in case of a single-sampling strategy for blood culture. Eur J Clin Microbiol Infect Dis. 2011 Dec;30(12):1537-41. doi: 10.1007/s10096-011-1257-3. Epub 2011 Apr 18. |
| 29621616 | Background | Dargere S, Cormier H, Verdon R. Contaminants in blood cultures: importance, implications, interpretation and prevention. Clin Microbiol Infect. 2018 Sep;24(9):964-969. doi: 10.1016/j.cmi.2018.03.030. Epub 2018 Apr 3. |
| 23490046 | Background | Kirn TJ, Weinstein MP. Update on blood cultures: how to obtain, process, report, and interpret. Clin Microbiol Infect. 2013 Jun;19(6):513-20. doi: 10.1111/1469-0691.12180. Epub 2013 Mar 13. |
| 25753137 | Background | Opota O, Croxatto A, Prod'hom G, Greub G. Blood culture-based diagnosis of bacteraemia: state of the art. Clin Microbiol Infect. 2015 Apr;21(4):313-22. doi: 10.1016/j.cmi.2015.01.003. Epub 2015 Jan 16. |
| 27242721 | Background | Lamy B, Dargere S, Arendrup MC, Parienti JJ, Tattevin P. How to Optimize the Use of Blood Cultures for the Diagnosis of Bloodstream Infections? A State-of-the Art. Front Microbiol. 2016 May 12;7:697. doi: 10.3389/fmicb.2016.00697. eCollection 2016. |
| 22738875 | Background | Lin HH, Liu YF, Tien N, Ho CM, Hsu LN, Lu JJ. Evaluation of the blood volume effect on the diagnosis of bacteremia in automated blood culture systems. J Microbiol Immunol Infect. 2013 Feb;46(1):48-52. doi: 10.1016/j.jmii.2012.03.012. Epub 2012 Jun 26. |
| 22709932 | Background | Snyder SR, Favoretto AM, Baetz RA, Derzon JH, Madison BM, Mass D, Shaw CS, Layfield CD, Christenson RH, Liebow EB. Effectiveness of practices to reduce blood culture contamination: a Laboratory Medicine Best Practices systematic review and meta-analysis. Clin Biochem. 2012 Sep;45(13-14):999-1011. doi: 10.1016/j.clinbiochem.2012.06.007. Epub 2012 Jun 16. |
| 21194791 | Background | Caldeira D, David C, Sampaio C. Skin antiseptics in venous puncture-site disinfection for prevention of blood culture contamination: systematic review with meta-analysis. J Hosp Infect. 2011 Mar;77(3):223-32. doi: 10.1016/j.jhin.2010.10.015. Epub 2010 Dec 30. |
| 24766148 | Background | Dargere 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. |
| 9114192 | Background | Cockerill FR 3rd, Hughes JG, Vetter EA, Mueller RA, Weaver AL, Ilstrup DM, Rosenblatt JE, Wilson WR. Analysis of 281,797 consecutive blood cultures performed over an eight-year period: trends in microorganisms isolated and the value of anaerobic culture of blood. Clin Infect Dis. 1997 Mar;24(3):403-18. doi: 10.1093/clinids/24.3.403. |
| 26456740 | Background | Andrews AL, Simpson AN, Heine D, Teufel RJ 2nd. A Cost-Effectiveness Analysis of Obtaining Blood Cultures in Children Hospitalized for Community-Acquired Pneumonia. J Pediatr. 2015 Dec;167(6):1280-6. doi: 10.1016/j.jpeds.2015.09.025. Epub 2015 Oct 9. |
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| 27227924 | Background | Yamamoto S, Yamazaki S, Shimizu T, Takeshima T, Fukuma S, Yamamoto Y, Tochitani K, Tsuchido Y, Shinohara K, Fukuhara S. Body Temperature at the Emergency Department as a Predictor of Mortality in Patients With Bacterial Infection. Medicine (Baltimore). 2016 May;95(21):e3628. doi: 10.1097/MD.0000000000003628. |
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| 7063747 | Background | Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology. 1982 Apr;143(1):29-36. doi: 10.1148/radiology.143.1.7063747. |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D009181 | Mycoses |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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