Skip to main content
OpenTrials
Completed

NCT Number: NCT04573894

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Blood Culture Contamination Bacteremia Bacterial Infections Bacterial Infections and Mycoses Contamination Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU of Nancy

Nancy, 54500, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients with less than 3 blood culture bottles collected

Treatment and study plan

Procalcitonin dosage

Diagnostic Test

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

Primary outcomes

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

    Time frame: 24 hours

    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).

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

    Time frame: 24 hours

    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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Diagnostic Performance of Plasma Procalcitonin in Screening for Contamination When Detecting Potential Contaminants in Blood Cultures

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2020
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.