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Pulmonary Embolism and PCT. PE-PCT Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02261610
First Posted: October 10, 2014
Last Update Posted: September 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Thermo Fisher Scientific
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose

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.


Condition Intervention
Pulmonary Embolism With Pulmonary Infarction and Fever Procedure: Procalcitonin algorithm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interest of PCT in the Management of Antibiotic for the Patient With a Febrile Pulmonary Embolism.

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Percentage of patient treated by antibiotics in each group [ Time Frame: at day 1 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 62
Study Start Date: November 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clinical group
In the first group of patients, the use of antibiotics will be guided by clinical (clinical group).
Procedure: Procalcitonin algorithm
Procalcitonin algorithm (usually used for lower respiratory tract) guide antibiotic therapy
PCT group
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

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 pulmonary infarction. 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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18 years
  • CT diagnosis of pulmonary embolism with signs of pulmonary infarction
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261610


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    0473751195    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Thermo Fisher Scientific
Investigators
Principal Investigator: Farès MOUSTAFA University Hospital, Clermont-Ferrand
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02261610     History of Changes
Other Study ID Numbers: CHU-0203
2014-A00046-41
First Submitted: September 5, 2014
First Posted: October 10, 2014
Last Update Posted: September 21, 2015
Last Verified: September 2015

Keywords provided by University Hospital, Clermont-Ferrand:
PCT algorithm
Antibiotic
Pulmonary embolism

Additional relevant MeSH terms:
Infarction
Embolism
Pulmonary Embolism
Pulmonary Infarction
Ischemia
Pathologic Processes
Necrosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Calcitonin
Anti-Infective Agents
Antitubercular Agents
Bone Density Conservation Agents
Physiological Effects of Drugs