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CompletedNCT04573894Updated Oct 5, 2020

Diagnostic Performance of Plasma Procalcitonin for the Detection of Blood Cultures Contaminations

An observational study in Blood Culture Contamination, Bacteremia and Contamination, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-05.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
147
Ages
18 Years and older
Sex
All
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Study summary

In blood cultures, species considered as potentially contaminating (coagulase negative staphylococci (CNS), Bacillus spp., Corynebacterium spp., Cutibacterium acnes, Micrococcus spp., viridans group streptococci, and Clostridium perfringens) can, however, be responsable for true bacteremia.

Blood levels of the prohormone procalcitonin (PCT) markedly increase in the early stages of bacterial infections. The aim of our study is to determine the role of plasma PCT as a biomarker differentiating blood culture contaminations from true bacteremia.

Read the detailed description

Blood culture contamination is defined by the introduction into of a microorganism into blood culture bottles from either the patient's or healthcare worker's flora, or the immediate environment during specimen collection. Species considered as potentially contaminating (coagulase negative staphylococci (CNS), Bacillus spp., Corynebacterium spp., Cutibacterium acnes, Micrococcus spp., viridans group streptococci, and Clostridium perfringens) can, however, be responsible for true bacteremia. If an organism belonging to one of those species is detected in isolates, rapidly and accurately assessing its contaminant or infectious potential is hence important to ensure effective antibiotic therapy as well as to reduce financial burden caused by unnecessary treatments, and additional clinical and laboratory costs.

Blood levels of the prohormone procalcitonin (PCT) markedly increase in the early stages of bacterial infections. The aim of our study is to determine the role of plasma PCT as a biomarker differentiating blood culture contaminations from true bacteremia.

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Conditions studied

  • Blood Culture Contamination
  • Bacteremia
  • Contamination

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Keywords

  • Procalcitonin
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In context

Bacteremia

322 studies on the registry are indexed under Bacteremia; 49 are open to participants now.

This study's enrollment of 147 is below the median of 269 across 133 observational studies indexed under Bacteremia.

Browse Bacteremia studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients hospitalized at the Nancy CHRU and at the Lorraine Cancer Institute (ICL) from January 2016 to May 2019 Patients screened for positive blood culture to one of the following microorganisms: coagulase negative staphylococci, viridans group streptococci; as well as procalcitonin levels measured at 24 hours.

Inclusion criteria

  • At least one blood culture positive for of the following microorganisms: coagulase negative staphylococci, viridans group streptococci
  • PCT levels measurement on the day of blood culture specimen collection
  • Adult patients

Exclusion criteria

Exclusion Criteria:

  • Patients with less than 3 blood culture bottles collected
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
147 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Positives blood cultures

    Collection of clinical and biological data of patients with blood cultures positives for potential contaminants, as well as PCT levels measurements, from January 2016 to May 2019 at the Nancy CHRU

    Diagnostic Test: Procalcitonin dosage

Interventions

  • Diagnostic testProcalcitonin dosage

    Plasma PCT levels measured by automated enzyme immunoassay (Kryptor).

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What researchers measure

Primary outcomes

  1. To evaluate the diagnostic potential of plasma procalcitonin in detecting blood culture contamination

    True contamination will be considered if all of the following biological criteria are met: * Only one bottle collected is positive * The growth time in the first positive bottle is more than 20 hours Plasma proclacitonin levels measured by automated enzyme immunoassay (Kryptor).

    Time frame: 24 hours

Secondary outcomes

  1. To compare plasma PCT levels in patients with true bacteremia, probable bacteremia and contamination caused by the presence of bacterial species with high contaminant potential

    Bacteremia will be considered as present (" true bacteremia ") if all of the following biological criteria are met: * The same microorganism (amongst CNS, viridans group streptococci) is isolated in 100% of blood culture bottles collected from a given patient * The growth time in the first positive bottle is less than or equal to 16 hours Probable bacteremia: * When biological criteria of bacteremia and contamination are not fulled * When a antibiotic therapy is administrated without focal infection identified by cliniciens

    Time frame: 24 hours

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Study locations

1 site
  • CHRU of Nancy
    Nancy, 54500, France
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References and documents

Publications

  • Lu B, Shi L, Zhu F, Zhao H. Clinical Utility of the Time-to-Positivity/Procalcitonin Ratio to Predict Bloodstream Infection Due to Coagulase-Negative Staphylococci. Lab Med. 1 nov 2013;44(4):313-8.
  • Schuetz P, Mueller B, Trampuz A. Serum procalcitonin for discrimination of blood contamination from bloodstream infection due to coagulase-negative staphylococci. Infection. 2007 Oct;35(5):352-5. doi: 10.1007/s15010-007-7065-0. Epub 2007 Sep 19. PubMed 17882355 ↗
  • Schuetz P, Albrich W, Mueller B. Procalcitonin for diagnosis of infection and guide to antibiotic decisions: past, present and future. BMC Med. 2011 Sep 22;9:107. doi: 10.1186/1741-7015-9-107. PubMed 21936959 ↗
  • Berthezene C, Aissa N, Manteaux AE, Gueant JL, Oussalah A, Lozniewski A. Accuracy of procalcitonin for diagnosing peripheral blood culture contamination among patients with positive blood culture for potential contaminants. Infection. 2021 Dec;49(6):1249-1255. doi: 10.1007/s15010-021-01697-4. Epub 2021 Sep 15. PubMed 34524647 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04573894
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Oct 5, 2020
Start date
Jun 1, 2020
Primary completion
Jul 31, 2020
Completion
Sep 5, 2020
Last update
Oct 5, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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