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Pulmonary Embolism and PCT. PE-PCT Study

Primary Purpose

Pulmonary Embolism With Fever

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Procalcitonin algorithm
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Embolism With Fever focused on measuring PCT algorithm, Antibiotic, Pulmonary embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

clinical group

PCT group

Arm Description

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).

Outcomes

Primary Outcome Measures

Percentage of patient treated by antibiotics in each group

Secondary Outcome Measures

Percentage of death
Percentage of antibiotics stop
Rate of new hospitalization during the following month

Full Information

First Posted
September 5, 2014
Last Updated
April 1, 2021
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Thermo Fisher Scientific, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02261610
Brief Title
Pulmonary Embolism and PCT. PE-PCT Study
Official Title
Interest of PCT in the Management of Antibiotic for the Patient With a Febrile Pulmonary Embolism.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
difficulty of recrutement
Study Start Date
November 26, 2014 (Actual)
Primary Completion Date
July 24, 2019 (Actual)
Study Completion Date
November 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Thermo Fisher Scientific, Inc

4. Oversight

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism With Fever
Keywords
PCT algorithm, Antibiotic, Pulmonary embolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clinical group
Arm Type
Experimental
Arm Description
In the first group of patients, the use of antibiotics will be guided by clinical (clinical group).
Arm Title
PCT group
Arm Type
Other
Arm Description
In the second group, the use of antibiotics will be guided by the algorithm (PCT group).
Intervention Type
Procedure
Intervention Name(s)
Procalcitonin algorithm
Intervention Description
Procalcitonin algorithm (usually used for lower respiratory tract) guide antibiotic therapy
Primary Outcome Measure Information:
Title
Percentage of patient treated by antibiotics in each group
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Percentage of death
Time Frame
at day 1
Title
Percentage of antibiotics stop
Time Frame
at day 1
Title
Rate of new hospitalization during the following month
Time Frame
at 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farès MOUSTAFA
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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Pulmonary Embolism and PCT. PE-PCT Study

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