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Procalcitonin (PCT) as a Diagnostic Marker of Bacterial Infection in the Patients Admitted for Fever and/or Inflammatory Syndrome to the Internal Medicine Department (PCT-MI)

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ClinicalTrials.gov Identifier: NCT02898948
Recruitment Status : Unknown
Verified September 2016 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was:  Recruiting
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

Levels of PCT (a marker of bacterial infection) are highest during sepsis: in fact, PCT is normally produced by the C cells in the thyroid gland. PCT was initially studied by Assicot1 for distinguishing between bacterial meningitis and viral meningitis. The CALC-I gene codes for PCT. In the absence of infection, the extrathyroid mRNA expression of the CALC-I gene is repressed, and expression is restricted to neuroendocrine thyroid and pulmonary cells. Infection induces the ubiquitous expression of the CALC-I gene. PCT is not transformed into calcitonin in parenchymatous tissues. In a context of sepsis, the whole body acts as a neuroendocrine gland. Sepsis upregulates PCT mRNA expression much more than that of other cytokines.

PCT is used in critical care departments as a diagnostic marker, a guide to treatment (antibiotics are withdrawn if the level falls) and a prognostic marker.

There are few data on the diagnostic use of PCT in an internal medicine department. The available studies yielded contradictory results and only one prospective study has been performed . The objective was to study PCT in non-infectious, inflammatory pathologies and to establish whether PCT could distinguish infections from other inflammatory pathologies in patients in an internal medicine department. In a ROC curve analysis, a PCT threshold of 0.35 µmol/l gave the greatest specificity (88%) and sensitivity (72%). Other studies have been performed but featured small sample sizes and a retrospective design.

Of the various studies performed in internal medicine departments, none included patients presenting with a suspected bacterial infection (according to the clinician's interpretation) and lacking information on their bacterial status. In fact, these diagnoses are a core component of hospitalisation in internal medicine departments for fever or inflammatory syndrome. The investigators intend to include all patients, including those lacking information on their microbiological status).


Condition or disease Intervention/treatment
Systemic Inflammatory Response Syndrome Fever Biological: Procalcitonin (PCT) as a diagnostic marker of bacterial infection

Study Type : Observational
Estimated Enrollment : 133 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procalcitonin (PCT) as a Diagnostic Marker of Bacterial Infection in the Patients Admitted for Fever and/or Inflammatory Syndrome to the Internal Medicine Department
Study Start Date : February 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. PCT level [ Time Frame: Day 0 ]
    to determine whether PCT is a good diagnostic marker in patients presenting with fever and/or inflammatory syndrome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18 or over hospitalized in the internal medicine department at Amiens University Hospital, presenting with fever (>38.5°C) and/or inflammatory syndrome (CRP >5 mg/l)
Criteria

Inclusion Criteria:

  • Patients aged 18 or over hospitalized in the internal medicine department at Amiens University Hospital, presenting with fever (>38.5°C) and/or inflammatory syndrome (CRP >5 mg/l) and having given their consent will be included.

Exclusion Criteria:

  • Haemodialyzed patients.
  • Age under 18.
  • Legal guardianship.
  • Refusal by the patient, or inability to give consent.
  • Patients on antibiotics for more than 12 hours at the time of the PCT assay (the half-life of PCT is 22 hours, and the level falls rapidly when antibiotics are administered).
  • PCT assays more than 12 hours after hospitalisation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898948


Contacts
Contact: Jean SCHMIDT, MD +33 3 22 66 76 90 schmidt.jean@chu-amiens.fr

Locations
France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Jean SCHMIDT, MD    +33 3 22 66 76 90    schmidt.jean@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Jean SCHMIDT, MD CHU Amiens

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02898948     History of Changes
Other Study ID Numbers: RNI2015-38 Dr Schmidt
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Keywords provided by Centre Hospitalier Universitaire, Amiens:
procalcitonin
bacterial infection

Additional relevant MeSH terms:
Syndrome
Infection
Fever
Bacterial Infections
Systemic Inflammatory Response Syndrome
Disease
Pathologic Processes
Body Temperature Changes
Signs and Symptoms
Inflammation
Shock
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs