An interventional study of Procalcitonin algorithm in Pulmonary Embolism With Fever, sponsored by University Hospital, Clermont-Ferrand. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-05.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
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.
The investigators propose to realize a single-center prospective, randomized, parallel group, to compare two groups of patients admitted with febrile pulmonary embolism . In the first group of patients, the use of antibiotics will be guided by clinical (clinical group). In the second group, the use of antibiotics will be guided by the algorithm (PCT group). The guided by the PCT algorithm is only given aid the clinician in the therapeutic management without its application only requires the doctor in charge of the patient. So if your doctor may advocate (or deemed necessary) to continue (or start) antibiotics even if the PCT algorithm would allow him to stop (or not initiate).
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 18 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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In the first group of patients, the use of antibiotics will be guided by clinical (clinical group).
Procedure: Procalcitonin algorithm
In the second group, the use of antibiotics will be guided by the algorithm (PCT group).
Procedure: Procalcitonin algorithm
Procalcitonin algorithm (usually used for lower respiratory tract) guide antibiotic therapy
Percentage of patient treated by antibiotics in each group
Time frame: at day 1
Percentage of death
Time frame: at day 1
Percentage of antibiotics stop
Time frame: at day 1
Rate of new hospitalization during the following month
Time frame: at 1 month
This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand