PROcalcitonin Pneumonia / Pneumonitis Associated With ASPIration (PROPASPI)

May 28, 2020 updated by: Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • CHU de Besancon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the duration of antibiotic treatment
Time Frame: during the first 15 days following admission to the ICU
during the first 15 days following admission to the ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Gilles CAPELLIER, MDPH, Centre Hospitalier Régional Universitaire de Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2015

Primary Completion (Actual)

November 28, 2019

Study Completion (Actual)

November 28, 2019

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2013/213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inhalation Pneumonia

Clinical Trials on Blood sample

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe