How to Reduce Unnecessary Blood Cultures: Construction & NCT05686577

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT05686577
Other study ID #	DR200089 (PROBIty)
Secondary ID
Status	Completed
Phase
First received
Last updated
Start date	November 22, 2022
Est. completion date	October 25, 2023

Study information
Verified date	February 2024
Source	University Hospital, Tours
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status	Completed
Enrollment	2411
Est. completion date	October 25, 2023
Est. primary completion date	September 27, 2023
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	Inclusion Criteria: - Male or female, age 18 years or older - Patient admitted to an ICU or ICU - patient with a blood culture sample as part of care Exclusion Criteria: - Patient already included in this study during a previous hospitalisation - Opposition expressed for participation in the study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention

Locations
Country	Name	City
France	CHU Brest	Brest
France	CHU Dijon	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

Sponsors *(1)*
Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France,

References & Publications (24)

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. — View Citation

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. — View Citation

Coburn B, Morris AM, Tomlinson G, Detsky AS. Does this adult patient with suspected bacteremia require blood cultures? JAMA. 2012 Aug 1;308(5):502-11. doi: 10.1001/jama.2012.8262. Erratum In: JAMA. 2013 Jan 23;309(4):343. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Eliakim-Raz N, Bates DW, Leibovici L. Predicting bacteraemia in validated models--a systematic review. Clin Microbiol Infect. 2015 Apr;21(4):295-301. doi: 10.1016/j.cmi.2015.01.023. Epub 2015 Feb 10. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Laukemann S, Kasper N, Kulkarni P, Steiner D, Rast AC, Kutz A, Felder S, Haubitz S, Faessler L, Huber A, Fux CA, Mueller B, Schuetz P. Can We Reduce Negative Blood Cultures With Clinical Scores and Blood Markers? Results From an Observational Cohort Study. Medicine (Baltimore). 2015 Dec;94(49):e2264. doi: 10.1097/MD.0000000000002264. Erratum In: Medicine (Baltimore). 2017 Feb 17;96(7):e6197. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Peres Bota D, Melot C, Lopes Ferreira F, Vincent JL. Infection Probability Score (IPS): A method to help assess the probability of infection in critically ill patients. Crit Care Med. 2003 Nov;31(11):2579-84. doi: 10.1097/01.CCM.0000094223.92746.56. — View Citation

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. — View Citation

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. Erratum In: JAMA. 2016 May 24-31;315(20):2237. — View Citation

Shapiro NI, Wolfe RE, Wright SB, Moore R, Bates DW. Who needs a blood culture? A prospectively derived and validated prediction rule. J Emerg Med. 2008 Oct;35(3):255-64. doi: 10.1016/j.jemermed.2008.04.001. Epub 2008 May 16. — View Citation

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. — View Citation

Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome
Type	Measure	Description	Time frame
Primary	Area under the ROC curve of the predictive performance of the score for predicting bacteremia or fungemia.		day 1- day 28
Secondary	Area under the ROC curve of the diagnostic performance of body temperature to predict bacteremia or fungemia;		day 1- day 28
Secondary	Area under the ROC curve of the diagnostic performance of the Shapiro score for predicting bacteremia or fungemia;		day 1- day 28
Secondary	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
Secondary	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
Secondary	Descriptive study of the contribution of blood cultures, whatever their results, to the prescription of anti-infectives.		day 1- day 28
Secondary	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

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How to Reduce Unnecessary Blood Cultures: Construction and Validation of a Predictive Score for Blood Culture Positivity in Intensive Care

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

References & Publications (24)

Outcome