Pulmonary Embolism and PCT. PE-PCT Study

NCT02261610 | Terminated

• 2 other identifiers: CHU-02032014-A00046-41
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism With Fever

Keywords

PCT algorithm; Antibiotic; Pulmonary embolism

Outcome Measures

Primary Outcomes (1)

• Percentage of patient treated by antibiotics in each group

  at day 1

Secondary Outcomes (3)

• Percentage of death

  at day 1

• Percentage of antibiotics stop

  at day 1

• Rate of new hospitalization during the following month

  at 1 month

Study Arms (2)

clinical group

EXPERIMENTAL

In the first group of patients, the use of antibiotics will be guided by clinical (clinical group).

Procedure: Procalcitonin algorithm

PCT group

OTHER

In the second group, the use of antibiotics will be guided by the algorithm (PCT group).

Procedure: Procalcitonin algorithm

Interventions

Procalcitonin algorithm PROCEDURE

Procalcitonin algorithm (usually used for lower respiratory tract) guide antibiotic therapy

PCT group; clinical group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• CT diagnosis of pulmonary embolism
• Temperature\> 37.8 ° C
• About affiliated to the social security
• Prior agreement with the patient signing a consent

You may not qualify if:

• Pregnant Woman
• Refusal of the patient
• Pulmonary Neoplasia
• Antibiotic ongoing for more than 24 hours at the time of diagnosis of pulmonary embolism
• Cardiogenic shock (hypotension with mean arterial pressure less than 65 bpm)
• Suspicion of infection other than lung associated (associated urinary tract infection, prostatitis, ENT infection, sinusitis ...)
• Patient under guardianship
• Patients unable to give consent

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Thermo Fisher Scientific, Inc: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Farès MOUSTAFA

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: October 10, 2014
• Study Start: November 26, 2014
• Primary Completion: July 24, 2019
• Study Completion: November 24, 2019
• Last Updated: April 5, 2021

Record last verified: 2020-11

Locations

FR (1)