NCT02261610

Pulmonary Embolism and PCT. PE-PCT Study

Terminated NA Last updated 5 April 2021

What this trial tests

NA trial testing Procalcitonin algorithm in Pulmonary Embolism With Fever in 18 participants. Terminated before completion.

Timeline

26 November 2014

Primary endpoint
24 July 2019

24 November 2019

Quick facts

Lead sponsor	University Hospital, Clermont-Ferrand
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	18
Start date	26 November 2014
Primary completion	24 July 2019
Estimated completion	24 November 2019
Sites	1 location across France

Drugs / interventions tested

• Procalcitonin algorithm

Conditions studied

• Pulmonary Embolism With Fever — all drugs for Pulmonary Embolism With Fever →

Sponsor

University Hospital, Clermont-Ferrand

Who can join

18 and older, any sex, with Pulmonary Embolism With Fever. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The clinical manifestations of pulmonary embolism vary greatly from the absence of specific clinical symptoms to cardiogenic shock or cardiac arrest. Clinical form of EP represented by "lung superinfection", also called "pulmonary embolism superinfected" is common and represents up to 30% of initial clinical presentations; she been few evaluations in clinical research. The reality of the bacterial infection remains controversial and the clinical presentation often leads to the prescription of empirical antibiotic therapy, often unnecessary in many cases. Number of antibiotic prescriptions are probably inappropriate.

Fever has long been recognized as a sign associated with pulmonary embolism. Stein et al reported a temperature above 37.5 ° C on 50% of patients with acute pulmonary embolism without actually clarified whether this was related to temperature with a pulmonary embolism or other associated cause. Murray et al estimated that greater than 38 ° C was explained by pulmonary embolism in 57.1% of patients while in the PIOPED study, only 14% of patients had fever with no other cause identified as pulmonary embolism. Fever due to pulmonary embolism is often low intensity (often less than 38.3) and of short duration, with a peak on the day of pulmonary embolism and a gradual decrease of about 1 week. The pathophysiology of fever in pulmonary embolism has not yet was completely clarified. It is suggested that a combination of several factors involved pyrogenic myocardial tissue necrosis and releasing pro-inflammatory cytokines, hemorrhage, vascular irritation or inflammation, atelectasis or local superinfection.

Since 2004, the PCT has become a marker helping the initiation of antibiotic therapy in patients with community-acquired pneumonia. This is especially verified in patients admitted for acute exacerbation of chronic obstructive bronchitis. In the latter case, the use of PCT reduces inappropriate antibiotic prescribing. Thus helping the clinician by measuring biomarkers such as PCT is based on writing an algorithm leading or not to use antibiotics.

The use of an algorithm involving the PCT could just as for infectious pneumonia or COPD, of interest in the febrile pulmonary embolism to distinguish febrile forms related to bacterial infections febrile forms of EP to other causes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections.
   Schuetz P, Wirz Y, Sager R, Christ-Crain M, et al · · 2017 · cited 206× · PMID 29025194 · DOI 10.1002/14651858.cd007498.pub3