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Improving treatment for severe infections using rapid diagnostic tools

A Randomized Prospective Clinical Trial to Assess Procalcitonin-guidance and Molecular-guided Diagnosis as Mainstay for Therapy of Severe Infections (the MODIFY Trial)

Phase 3 Interventional Hellenic Institute for the Study of Sepsis · NCT05909683

This study is testing if using quick diagnostic tools can help doctors treat severe infections better and save lives in patients with sepsis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment190 (estimated)
Ages18 Years and up
SexAll
SponsorHellenic Institute for the Study of Sepsis Academic / other
Locations12 sites (Athens, Chaidari and 11 other locations)
Trial IDNCT05909683 on ClinicalTrials.gov

What this trial studies

The MODIFY trial is a randomized, open-label, phase 3 study conducted in multiple ICUs and internal medicine departments across Greece. It aims to enhance the management of severe infections by integrating rapid diagnostic tools, including the Blood Culture Identification 2 Panel (BCID2) and Reveal Rapid AST, along with procalcitonin (PCT) levels. This approach seeks to facilitate early identification of pathogens and their antibiotic sensitivities, thereby optimizing antimicrobial therapy and potentially reducing mortality rates associated with sepsis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with sepsis as defined by the Sepsis-3 criteria.

Not a fit: Patients who do not have sepsis or those who are unable to provide informed consent due to their medical condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and timely treatment of severe infections, ultimately improving patient outcomes.

How similar studies have performed: Other studies utilizing rapid diagnostic tools for managing severe infections have shown promising results, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or female
* For women of child-bearing potential, willingness to avoid pregnancy during the study and agreement to notify investigator if pregnancy occurs.
* Age more than or equal to 18 years
* Patients who have completed their participation in another study for more than 30 days can be included in this study.
* Written informed consent provided by the patient or by their legal representative in case of patients unable to consent due to sepsis onset affecting their mental capacity.
* Sepsis defined by the Sepsis-3 definition; this is defined separately for community-acquired sepsis and for hospital-acquired sepsis. Community-acquired sepsis is defined as any SOFA score 2 points or more for patients admitted in hospital emergencies with community-acquired pneumonia (CAP), community-acquired acute pyelonephritis (AP) or community-acquired primary bacteremia (BSI). CAP, AP and BSI are considered community-acquired for patients who have no history of hospitalization lasting more than 2 days the last 90 days or who are not under hemodialysis or who are not residents of long-term care facilities. Hospital-acquired sepsis is defined as any SOFA score increase by 2 points or more from the admission SOFA score for patients with onset of hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acute pyelonephritis (AP) or primary bacteremia (BSI) at least 48 hours after hospital admission. For patients with history of hospitalization lasting more than 2 days the last 90 days or who are under hemodialysis or who are residents of long-term care facilities and are admitted to hospital with HAP, VAP, AP and BSI the definition of hospital-acquired sepsis applies. In this case, the baseline SOFA score is considered as the known SOFA score before infection onset.
* Presence of one of the following infections: community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acute pyelonephritis (AP) and primary bacteremia (BSI).
* Positive blood culture

Exclusion Criteria:

* Failure to obtain written consent to participate
* Previous enrollment in this study within the past 90 days. Patients enrolled in another study will not be accepted.
* Patients in pregnancy or breastfeeding. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
* Patients receiving prolonged antibiotic therapies (e.g. endocarditis, implantable device-associated infection, cerebral/hepatic abscess, osteomyelitis, meningitis)
* Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.)
* Patients with infection due to Mycobacterium tuberculosis.
* Patients suffering from cystic fibrosis
* Severely immunocompromised patients such as a) patients with infection by the human immunodeficiency virus and with a CD4 count of less than 200 cells/mm3; b) neutropenic patients with less than 500 neutrophils/mm3; and c) patients with solid organ transplantation.

Where this trial is running

Athens, Chaidari and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions SepsisSevere infectionsAntibioticsProcalcitoninBlood Culture Identification 2 PanelReveal Rapid AST system
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.