A RANDOMIZED PROSPECTIVE CLINICAL TRIAL TO ASSESS PROCALCITONIN-GUIDANCE AND MOLECULAR-GUIDED DIAGNOSIS AS MAINSTAY FOR THERAPY OF SEVERE INFECTIONS (The MODIFY trial)

Phase 1

Recruiting

• Conditions: Severe infections; MedDRA version: 20.0Level: PTClassification code: 10040047Term: Sepsis Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2022-502962-26-00
• Lead Sponsor: Hellenic Institute For The Study Of Sepsis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-10
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 190

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, 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, 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., Patients who have completed their participation in another study for more than 30 days can be included in this study.

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified