NCT02862314: PROPASPI

PROcalcitonin Pneumonia / Pneumonitis Associated With ASPIration

Completed Phase 4 Last updated 20 April 2025

What this trial tests

Phase 4 trial testing Blood sample in Inhalation Pneumonia in 167 participants. Completed in 28 November 2019.

Timeline

24 February 2015

Primary endpoint
28 November 2019

28 November 2019

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Besancon
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	167
Start date	24 February 2015
Primary completion	28 November 2019
Estimated completion	28 November 2019
Sites	1 location across France

Drugs / interventions tested

• Blood sample — full drug profile →

Conditions studied

• Inhalation Pneumonia — all drugs for Inhalation Pneumonia →

Sponsor

Centre Hospitalier Universitaire de Besancon

Who can join

18 and older, any sex, with Inhalation Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Procalcitonin to initiate or discontinue antibiotics in acute respiratory tract infections.
   Schuetz P, Wirz Y, Sager R, Christ-Crain M, et al · · 2017 · cited 206× · PMID 29025194 · DOI 10.1002/14651858.cd007498.pub3
2. Impact on antimicrobial consumption of procalcitonin-guided antibiotic therapy for pneumonia/pneumonitis associated with aspiration in comatose mechanically ventilated patients: a multicenter, randomized controlled study.
   Labro G, Aptel F, Puyraveau M, Paillot J, et al · · 2021 · cited 5× · PMID 34636974 · DOI 10.1186/s13613-021-00931-4