Unit:
Faculty of MedicineLibrary of the School of Health Sciences
Author:
Kyriazopoulou Evdoxia
Dissertation committee:
Μπούμπας Δημήτριος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Ορφανός Στυλιανός, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Δημόπουλος Γεώργιος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Γιαμαρέλλος-Μπουρμπούλης Ευάγγελος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Σαμπατάκου Ελένη, Αναπληρώτρια Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Σαμάρκος Μιχαήλ, Αναπληρωτής Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Πουλάκου Γαρυφαλλιά, Επίκουρη Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Original Title:
Mια προοπτική τυχαιοποιημένη κλινική μελέτη για την εκτίμηση της χρήσης της προκαλσιτονίνης στον καθορισμό της διάρκειας της αντιμικροβιακής αγωγής με παράλληλη ωφέλεια τη μείωση των χρόνιων λοιμωδών επιπλοκών: Μελέτη PROGRESS
Translated title:
Α randomized prospective clinical trial to assess the role of procalcitonin-guided antimicrobial therapy to reduce long-term infections sequelae (Τhe PROGRESS trial)
Summary:
Rationale Although early antimicrobial discontinuation guided by procalcitonin (PCT) has showed decreased antibiotic consumption in lower respiratory tract infections (LRTIs), the outcomes in long-term sepsis sequelae remain unclear.
Objective To investigate if PCT-guidance may reduce the incidence of long-term infection-associated adverse events in sepsis.
Methods In this multicenter trial, 266 sepsis (by Sepsis-3 definitions) patients with LRTIs, acute pyelonephritis, or primary bloodstream infection were randomized (1:1) to receive either PCT-guided discontinuation of antimicrobials or standard-of-care (SOC). The discontinuation criterion was ≥80% reduction in PCT levels or any PCT ≤0.5 μg/l at day 5 or later. The primary outcome was the rate of infection-associated adverse events at day 180, a composite of the incidence of any new infection by Clostridioides difficile or multidrug-resistant organisms (MDRO), or any death attributed to baseline C. difficile or MDRO infection. Secondary outcomes included 28-day mortality, length of antibiotic therapy (LOT), and cost of hospitalization.
Measurements and Main Results The rate of infection-associated adverse events was 7.2% (95% CI, 3.8-13.1%; 9/125) versus 15.3% (95% CI, 10.1-22.4%; 20/131) (hazard ratio [HR], 0.45; 95% CI, 0.20-0.98; P=0.045); 28-day mortality 15.2% (95% CI,10-22.5%; 19/125) versus 28.2% (95% CI, 21.2-36.5%; 37/131) (HR, 0.51; 95% CI, 0.29-0.89; P =0.02); and median LOT 5 (range 5 to 7) versus 10 (range 7 to 15) days (P <0.001) in the PCT and SOC arms, respectively. The cost of hospitalization was also reduced in the PCT arm.
Conclusions In sepsis, PCT-guidance was effective in reducing infection-associated adverse events, 28-day mortality, and cost of hospitalization.
Main subject category:
Health Sciences
Keywords:
Procalcitonin, Sepsis, Multidrug-resistant, Mortality
Number of references:
249
