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PROcalcitonin Pneumonia / Pneumonitis Associated With ASPIration (PROPASPI)

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.
 
ClinicalTrials.gov Identifier: NCT02862314
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

There is actually no consensus in place defining for which patients with suspected inhalation pneumonia antibiotic treatment should be initiated and what the duration of this antibiotic treatment should be.

This absence of recommendations results in excessive use of antibiotics, in emergence of multi-resistant strains and increase of costs. Several studies have been performed investigating antibiotic treatment based on procalcitonin values and have demonstrated a decreased use of antibiotics without change in mortality rates, in duration of hospitalization, in occurrence of super-infections or in infection relapse rate. Of the studies performed in an intensive care setting, none has specifically studied inhalation pneumonia.

The objective of this study is to determine whether use of a decisional algorithm based on procalcitonin values allows reducing antibiotics exposure in patients who are intubated because of coma in comparison with standard care according to actual guidelines and clinical experience with respect to ventilator-acquired pneumonia.

The study has a prospective, multi-centre, comparative, randomized, open design. It is a superiority study, with as primary parameter the duration of antibiotic therapy during the first 15 days after admission in the intensive care unit (ICU).

Patients can be included in this study if they are intubated for coma (Glasgow Coma Scale (GCS) ≤ 8) within 48 hours following admission to the hospital and with a foreseen duration of ventilation exceeding 48 hours.

There will be two treatment groups, stratified by centre and randomised in blocs of 4: one group for which treatment initiation and discontinuation will be guided by a procalcitonin-based decisional algorithm and a control group to whom antibiotics will be administered according to the standard protocols of each participating centre.

Based on an estimated duration of antibiotic treatment of 6.2 days, a risk -significance α level- of 5%, a power of 90% and a reduction of antibiotic treatment duration of 25% in the treatment arm guided by procalcitonin values, the number of patients to be included is 83 per treatment arm. Taking into account a loss of 10% for patients lost to follow-up, 166 patients should be included.


Condition or disease Intervention/treatment Phase
Inhalation Pneumonia Biological: Blood sample Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : February 24, 2015
Actual Primary Completion Date : November 28, 2019
Actual Study Completion Date : November 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: procalcitonin group
The procalcitonin concentration is measured at inclusion.
Biological: Blood sample
No Intervention: control group
Concentrations of procalcitonin are not measured. .



Primary Outcome Measures :
  1. the duration of antibiotic treatment [ Time Frame: during the first 15 days following admission to the ICU ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • aged 18 or older,
  • have undergone oro-tracheal intubation for a coma (Glasgow Coma Score below or equal to 8),
  • with mechanical ventilation initiated in the first 48 hours following hospital admission

Exclusion Criteria:

  • pregnancy,
  • patients under legal custody,
  • patients without health insurance,
  • patients included in another interventional clinical study involving infections or antibiotics and having the same primary parameter,
  • moribund patients,
  • situation in which the procalcitonin concentration could be increased without correlation to an infectious process (poly-traumatised patients,
  • surgical interventions within the last 4 days,
  • cardiorespiratory arrest,
  • administration of anti-thymocyte globulin,
  • immunodepressed patients (bone marrow transplant patients, patients with severe neutropenia),
  • patients with an absolute indication for administration of antibiotics at the moment of ICU admission (meningitis, pneumonia) or a chronic infection for which long-term antibiotic treatment is necessary (endocarditis, osteo-articular infections, mediastinitis, deep abscesses, pneumocystis infection, toxoplasmosis, tuberculosis)
  • patients with haemodynamic instability of septic origin or a respiratory insufficiency (defined by a ratio Pa02/Fi02 ≤ 200 mmHg and PEP ≥ 5 cmH2O)

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): NCT02862314


Locations
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France
CHU de Besançon
Besançon, France, 25030
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Gilles CAPELLIER, MDPH Centre Hospitalier Régional Universitaire de Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02862314    
Other Study ID Numbers: P/2013/213
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Procalcitonin
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections