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

NCT04573894 | Completed

• 1 other identifier: 2020PI140
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Culture Contamination; Bacteremia; Contamination

Keywords

Procalcitonin

Outcome Measures

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).

  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

  24 hours

Study Arms (1)

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

Procalcitonin dosage DIAGNOSTIC_TEST

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

Positives blood cultures

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

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.

You may qualify if:

• 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

You may not qualify if:

• Patients with less than 3 blood culture bottles collected

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU of Nancy

Nancy, 54500, France

Location

Related Publications (4)

• 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.

  BACKGROUND

• 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.

  PMID: 17882355 BACKGROUND

• 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.

  PMID: 21936959 BACKGROUND

• 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.

  PMID: 34524647 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Positive blood cultures Procalcitonine

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: June 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: September 5, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)