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

Bacteremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573894
• Other study ID #: 2020PI140
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: September 5, 2020

Study information

• Verified date: September 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: September 5, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Blood Culture Contamination
• Contamination

Intervention

Diagnostic Test:
• Procalcitonin dosage
Plasma PCT levels measured by automated enzyme immunoassay (Kryptor).

Locations

Country	Name	City	State
France	CHRU of Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (3)

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, 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. Review. — View Citation

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. Epub 2007 Sep 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	24 hours