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TerminatedNCT02261610Updated Apr 5, 2021

Pulmonary Embolism and PCT. PE-PCT Study

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

Why this study was terminated
difficulty of recrutement
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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).

02

Conditions studied

  • Pulmonary Embolism With Fever

Keywords

  • PCT algorithm
  • Antibiotic
  • Pulmonary embolism
03

In context

Pulmonary Embolism

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 →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    clinical group

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

    Procedure: Procalcitonin algorithm

  • Other
    PCT group

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

    Procedure: Procalcitonin algorithm

Interventions

  • ProcedureProcalcitonin algorithm

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

06

What researchers measure

Primary outcomes

  1. Percentage of patient treated by antibiotics in each group

    Time frame: at day 1

Secondary outcomes

  1. Percentage of death

    Time frame: at day 1

  2. Percentage of antibiotics stop

    Time frame: at day 1

  3. Rate of new hospitalization during the following month

    Time frame: at 1 month

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02261610
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Thermo Fisher Scientific, Inc
Responsible party
Sponsor
First posted
Oct 10, 2014
Start date
Nov 26, 2014
Primary completion
Jul 24, 2019
Completion
Nov 24, 2019
Last update
Apr 5, 2021

Study contacts

Farès MOUSTAFA
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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