Assessing the Procalcitonin-guidance and Molecular-guided Diagnosis for Therapy of Severe Infections (the MODIFY Trial)

Launched by HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS · Jun 9, 2023

Keywords

ClinConnect Summary

The MODIFY Trial is a clinical study that aims to improve the treatment of severe infections, specifically sepsis, which is a serious condition caused by the body's response to infection. This trial will take place in various Intensive Care Units (ICUs) and medical departments in Greece. Researchers are exploring new ways to quickly identify the specific germs causing these infections and how they respond to antibiotics. By using advanced testing methods, they hope to reduce unnecessary antibiotic use and improve outcomes for patients with sepsis.

To be eligible for this study, participants must be at least 18 years old and have a confirmed case of sepsis from specific types of infections, like pneumonia or bloodstream infections. They should also be able to provide consent, or have a legal representative do so if they are unable to due to their condition. If someone joins the trial, they can expect to undergo additional tests to help guide their treatment. It's important to note that certain patients, such as those who are pregnant or have specific severe health issues, will not be able to participate. This trial is currently recruiting participants.

Gender

ALL

Eligibility 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.