Blood Culture ContaminationNCT04573894
Diagnostic Performance of Plasma Procalcitonin for the Detection of Blood Cultures Contaminations
An observational study of Blood Culture Contamination and Bacteremia, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Culture Contamination, Bacteremia, Contamination
- What is being tested?
- Procalcitonin dosage
- How many people
- 147 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 5 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with less than 3 blood culture bottles collected
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance of Plasma Procalcitonin in Screening for Contamination When Detecting Potential Contaminants in Blood Cultures
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.
- Conditions
- Blood Culture Contamination, Bacteremia, Contamination
- Being tested
- Procalcitonin dosage
- Keywords
- Procalcitonin
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin dosageDiagnostic test
Plasma PCT levels measured by automated enzyme immunoassay (Kryptor).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Procalcitonin dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jun 2020
- Primary completion31 Jul 2020
- Study completion5 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood Culture ContaminationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573894
- Sponsor's protocol ID
- 2020PI140
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 17882355Schuetz 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 21936959Berthezene 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Plasma Procalcitonin in Screening for Contamination When Detecting Potential Contaminants in Blood Cultures
- ClinicalTrials.gov ID
- NCT04573894
- Acronym / sponsor ID
- 2020PI140
- Conditions
- Blood Culture Contamination, Bacteremia, Contamination
- Keywords
- Procalcitonin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 5 Sep 2020 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positives blood cultures | – | Diagnostic Test: Procalcitonin dosageCollection 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with less than 3 blood culture bottles collected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procalcitonin dosagePlasma PCT levels measured by automated enzyme immunoassay (Kryptor). | Diagnostic test | Positives blood cultures |
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- BackgroundLu 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: PubMed 17882355Schuetz 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.
- Background: PubMed 21936959Schuetz 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.
- Derived from this study: PubMed 34524647Berthezene 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.
- Individual participant dataSharing planned: No
Related trials for Blood Culture Contamination
Active, not recruiting
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RecruitingObservational study
Impact of Blood Cultures Drawn From Arterial Lines on the Incidence of Contamination, Detection of Bacteremia, and Blood Culture Volume
Bacteremia
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Blood Culture Collection Strategies for Suspected Bloodstream Infection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Culture Contamination and Bacteremia, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the diagnostic potential of plasma procalcitonin in detecting blood culture contamination (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573894, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.