NCT02898948: PCT-MI

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

Completed Last updated 23 January 2019

What this trial tests

trial testing Procalcitonin (PCT) as a diagnostic marker of bacterial infection in Systemic Inflammatory Response Syndrome in 116 participants. Completed in 18 October 2016.

Timeline

11 February 2016

Primary endpoint
18 October 2016

18 October 2016

Quick facts

Lead sponsor	Centre Hospitalier Universitaire, Amiens
Status	Completed
Study type	OBSERVATIONAL
Enrollment	116
Start date	11 February 2016
Primary completion	18 October 2016
Estimated completion	18 October 2016
Sites	1 location across France

Drugs / interventions tested

• Procalcitonin (PCT) as a diagnostic marker of bacterial infection — full drug profile →

Conditions studied

• Systemic Inflammatory Response Syndrome — all drugs for Systemic Inflammatory Response Syndrome →
• Fever — all drugs for Fever →

Sponsor

Centre Hospitalier Universitaire, Amiens

Who can join

18 and older, any sex, with Systemic Inflammatory Response Syndrome or Fever. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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PCT is used in critical care departments as a diagnostic marker, a guide to treatment (antibiotics are withdrawn if the level falls) and a prognostic marker.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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.