Pulmonary Embolism With FeverNCT02261610
Pulmonary Embolism and PCT. PE-PCT Study
A study testing Procalcitonin algorithm in people with Pulmonary Embolism With Fever, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism With Fever
- What is being tested?
- Procalcitonin algorithm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2014to 24 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of PCT in the Management of Antibiotic for the Patient With a Febrile Pulmonary Embolism.
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.
Read more
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).
- Conditions
- Pulmonary Embolism With Fever
- Being tested
- Procalcitonin algorithm
- Keywords
- PCT algorithm, Antibiotic, Pulmonary embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin algorithmProcedure or surgery
Procalcitonin algorithm (usually used for lower respiratory tract) guide antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| clinical group | Experimental | In the first group of patients, the use of antibiotics will be guided by clinical (clinical group). Receives: Procedure: Procalcitonin algorithm |
| PCT group | Other | In the second group, the use of antibiotics will be guided by the algorithm (PCT group). Receives: Procedure: Procalcitonin algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patient treated by antibiotics in each group
Measured: at day 1
Secondary outcomes (3)
Percentage of death
Measured: at day 1
Percentage of antibiotics stop
Measured: at day 1
Rate of new hospitalization during the following month
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study start26 Nov 2014
- Primary completion24 Jul 2019
- Study completion24 Nov 2019
Why it stopped: difficulty of recrutement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism With FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Thermo Fisher Scientific, Inc
- Responsible party
- Sponsor
- Investigators
- Farès MOUSTAFA, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261610
- Sponsor's protocol ID
- CHU-0203
- Other IDs
- 2014-A00046-41
- Status last verified
- Nov 2020
- First submitted
- 5 Sep 2014
- Last updated
- 5 Apr 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of PCT in the Management of Antibiotic for the Patient With a Febrile Pulmonary Embolism.
- ClinicalTrials.gov ID
- NCT02261610
- Acronym / sponsor ID
- CHU-0203
- Conditions
- Pulmonary Embolism With Fever
- Keywords
- PCT algorithm, Antibiotic, Pulmonary embolism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty of recrutement
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Thermo Fisher Scientific, Inc
- Study start
- 26 Nov 2014 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Nov 2019 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinical group | Experimental | Procedure: Procalcitonin algorithmIn the first group of patients, the use of antibiotics will be guided by clinical (clinical group). |
| PCT group | Other | Procedure: Procalcitonin algorithmIn the second group, the use of antibiotics will be guided by the algorithm (PCT group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procalcitonin algorithmProcalcitonin algorithm (usually used for lower respiratory tract) guide antibiotic therapy | Procedure or surgery | PCT group, clinical group |
Primary outcome
Percentage of patient treated by antibiotics in each group
Time frame: at day 1
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: difficulty of recrutement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farès MOUSTAFA principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procalcitonin algorithm in people with Pulmonary Embolism With Fever, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty of recrutement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patient treated by antibiotics in each group (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2021.