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

NCT05686577 | Completed

• 1 other identifier: DR200089 (PROBIty)
• Study Type: observational
• Target: 2,411
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Infection, Bacterial; Infection, Fungal; Bacteremia

Keywords

intensive care unit; blood culture; prediction; score

Outcome Measures

Primary Outcomes (1)

• Area under the ROC curve of the predictive performance of the score for predicting bacteremia or fungemia.

  day 1- day 28

Secondary Outcomes (6)

• 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

• 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

Study Arms (2)

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

Other: no intervention

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.

Other: no intervention

Interventions

no intervention OTHER

no intervention

learning database group; validation database group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

critical care patient with suspected infection.

You may qualify if:

• 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

You may not qualify if:

• Patient already included in this study during a previous hospitalisation
• Opposition expressed for participation in the study

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (10)

CHU Brest

Brest, France

Location

CHU Dijon

Dijon, France

Location

CHD La Roche sur Yon

La Roche-sur-Yon, France

Location

CH Le Mans

Le Mans, France

Location

CHU Nantes

Nantes, France

Location

CHR Orléans

Orléans, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Rennes

Rennes, France

Location

CHIU Strasbourg

Strasbourg, France

Location

CHU de Tours

Tours, 37044, France

Location

Related Publications (24)

• 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.

  PMID: 26903335 BACKGROUND

• 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.

  PMID: 28903154 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.

  PMID: 23473333 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.

  PMID: 29746948 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.

  PMID: 27552910 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.

  PMID: 21499970 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.

  PMID: 29621616 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.

  PMID: 23490046 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.

  PMID: 25753137 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.

  PMID: 27242721 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.

  PMID: 22738875 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.

  PMID: 22709932 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.

  PMID: 21194791 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.

  PMID: 24766148 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.

  PMID: 9114192 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.

  PMID: 26456740 BACKGROUND

• 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.

  PMID: 22851117 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.

  PMID: 27227924 BACKGROUND

• 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.

  PMID: 25677625 BACKGROUND

• 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.

  PMID: 18486413 BACKGROUND

• 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.

  PMID: 26656373 BACKGROUND

• 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.

  PMID: 14605527 BACKGROUND

• 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.

  PMID: 8844239 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.

  PMID: 7063747 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections; Mycoses; Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Denis GAROT

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: November 22, 2022
• Primary Completion: September 27, 2023
• Study Completion: October 25, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

FR (10)