Ongoing study
Official Study Title
A RANDOMIZED PROSPECTIVE CLINICAL TRIAL TO ASSESS PROCALCITONIN-GUIDANCE AND MOLECULAR-GUIDED DIAGNOSIS AS MAINSTAY FOR THERAPY OF SEVERE INFECTIONS (The MODIFY trial)
Brief Description
The aim of the study is to demonstrate if using a combined strategy of rapid molecular diagnosis with BioFire® FilmArray® Blood Culture Identification 2 Panel and the Reveal Rapid AST system with a PCT-guided rule of stop of antimicrobials, may impact on the outcomes of patients with severe infections. The primary outcome would be the number of days under treatment with broad-spectrum antimicrobials in the group receiving the MODIFY strategy compared to patients treated by standard of care.
Details
Status: Recruiting
Study Type: Interventional (Clinical Trial)
Study phase: III
Study sites: 15 sites in Greece
Target of enrolment: 190 participants
ClinicalTrials.gov Identifier: NCT05909683
EudraCT number: 2022-502962-26-00
National Organization for Medicines Approval: CTR011-23-00
National Ethics Committee Approval: 134/33
Study Start: September 2023
Condition/Disease studied: Sepsis; Severe Infections
Keywords: Sepsis; Severe Infections; Antimicrobials; Standard of care; PCT
Connect to the MODIFY trial portal