Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 11:44 PM
Study NCT ID:
NCT04573894
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2020-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Performance of Plasma Procalcitonin for the Detection of Blood Cultures Contaminations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Positive blood cultures Procalcitonine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-01', 'studyFirstSubmitDate': '2020-09-28', 'studyFirstSubmitQcDate': '2020-10-01', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the diagnostic potential of plasma procalcitonin in detecting blood culture contamination', 'timeFrame': '24 hours', 'description': 'True contamination will be considered if all of the following biological criteria are met:\n\n* Only one bottle collected is positive\n* The growth time in the first positive bottle is more than 20 hours Plasma proclacitonin levels measured by automated enzyme immunoassay (Kryptor).'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '24 hours', 'description': 'Bacteremia will be considered as present (" true bacteremia ") if all of the following biological criteria are met:\n\n* The same microorganism (amongst CNS, viridans group streptococci) is isolated in 100% of blood culture bottles collected from a given patient\n* The growth time in the first positive bottle is less than or equal to 16 hours\n\nProbable bacteremia:\n\n* When biological criteria of bacteremia and contamination are not fulled\n* When a antibiotic therapy is administrated without focal infection identified by cliniciens'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Procalcitonin'], 'conditions': ['Blood Culture Contamination', 'Bacteremia', 'Contamination']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17882355', 'type': 'BACKGROUND', '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. doi: 10.1007/s15010-007-7065-0. Epub 2007 Sep 19.'}, {'pmid': '21936959', 'type': 'BACKGROUND', 'citation': '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': '34524647', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nBlood 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.', 'detailedDescription': "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.\n\nBlood 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one blood culture positive for of the following microorganisms: coagulase negative staphylococci, viridans group streptococci\n* PCT levels measurement on the day of blood culture specimen collection\n* Adult patients\n\nExclusion Criteria:\n\n* Patients with less than 3 blood culture bottles collected'}, 'identificationModule': {'nctId': 'NCT04573894', 'briefTitle': 'Diagnostic Performance of Plasma Procalcitonin for the Detection of Blood Cultures Contaminations', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Diagnostic Performance of Plasma Procalcitonin in Screening for Contamination When Detecting Potential Contaminants in Blood Cultures', 'orgStudyIdInfo': {'id': '2020PI140'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Positives blood cultures', 'description': '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', 'interventionNames': ['Diagnostic Test: Procalcitonin dosage']}], 'interventions': [{'name': 'Procalcitonin dosage', 'type': 'DIAGNOSTIC_TEST', 'description': 'Plasma PCT levels measured by automated enzyme immunoassay (Kryptor).', 'armGroupLabels': ['Positives blood cultures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Nancy', 'country': 'France', 'facility': 'CHRU of Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}