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

Last updated: May 30, 2024
Sponsor: Hellenic Institute for the Study of Sepsis
Overall Status: Active - Recruiting

Phase

3

Condition

Soft Tissue Infections

Treatment

Standard of Care

Change of antimicrobials based on BCID2 and Reveal Rapid AST tests. Stop of antimicrobials based on PCT results.

Clinical Study ID

NCT05909683
MODIFY
2022-502962-26-00
  • Ages > 18
  • All Genders

Study Summary

MODIFY is a randomized, open-labeled, and prospective study that will be conducted in multiple Intensive Care Units (ICUs) and departments of Internal Medicine across Greece. It aims to change the traditional approach for the management of severe infections by integrating the results of BCID2, Reveal Rapid AST, and PCT, to improve patients' outcomes. Early and precise identification of the underlying causative pathogen along with the fast acquisition of the antimicrobial sensitivity results may positively impact the uncontrolled antimicrobial prescription.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female

  • For women of child-bearing potential, willingness to avoid pregnancy during thestudy 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 30days can be included in this study.

  • Written informed consent provided by the patient or by their legal representative incase of patients unable to consent due to sepsis onset affecting their mentalcapacity.

  • Sepsis defined by the Sepsis-3 definition; this is defined separately forcommunity-acquired sepsis and for hospital-acquired sepsis. Community-acquiredsepsis is defined as any SOFA score 2 points or more for patients admitted inhospital emergencies with community-acquired pneumonia (CAP), community-acquiredacute pyelonephritis (AP) or community-acquired primary bacteremia (BSI). CAP, APand BSI are considered community-acquired for patients who have no history ofhospitalization lasting more than 2 days the last 90 days or who are not underhemodialysis or who are not residents of long-term care facilities.Hospital-acquired sepsis is defined as any SOFA score increase by 2 points or morefrom the admission SOFA score for patients with onset of hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acute pyelonephritis (AP) or primarybacteremia (BSI) at least 48 hours after hospital admission. For patients withhistory of hospitalization lasting more than 2 days the last 90 days or who areunder hemodialysis or who are residents of long-term care facilities and areadmitted to hospital with HAP, VAP, AP and BSI the definition of hospital-acquiredsepsis applies. In this case, the baseline SOFA score is considered as the knownSOFA score before infection onset.

  • Presence of one of the following infections: community-acquired pneumonia (CAP),hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acutepyelonephritis (AP) and primary bacteremia (BSI).

  • Positive blood culture

Exclusion

Exclusion Criteria:

  • Failure to obtain written consent to participate

  • Previous enrollment in this study within the past 90 days. Patients enrolled inanother study will not be accepted.

  • Patients in pregnancy or breastfeeding. Women of child-bearing potential will bescreened by a urine pregnancy test before inclusion in the study

  • Patients receiving prolonged antibiotic therapies (e.g. endocarditis, implantabledevice-associated infection, cerebral/hepatic abscess, osteomyelitis, meningitis)

  • Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasmagondii, 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 humanimmunodeficiency 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 solidorgan transplantation.

Study Design

Total Participants: 190
Treatment Group(s): 2
Primary Treatment: Standard of Care
Phase: 3
Study Start date:
September 14, 2023
Estimated Completion Date:
July 25, 2025

Study Description

Early administration of antimicrobials remains the mainstay of treatment of severe infections. The time until start of antimicrobials is so crucial that every hour of delay impacts considerably on mortality. In everyday clinical practice even when antimicrobials are administered early, it is impossible to know whether they are appropriate or not because cultures of specimens collected from the patient require at least 48 to 72 hours to provide some information about the type of pathogen and the antimicrobial susceptibilities.

BioFire ® FilmArray ® possesses four Food and Drug Administration (FDA)-cleared panels of molecular diagnosis, capable of detecting multiple targets in less than an hour of sample handling. Among them, Blood Culture Identification 2 Panel (BCID2) covers 43 targets. BCID2 provides information on the genes of resistance to antibiotics the microorganisms carry. BCID2 combined with fast AST can, however, introduce revolutionary changes in minimizing the time until the appropriate antimicrobial is prescribed. The concept of Reveal is to provide AST for a full panel of antibiotics if one Gram-negative isolate is identified in the blood flask.

Evaluation of the appropriateness of the administered therapy and decision about discontinuation or de-escalation of antimicrobials, is based on the use of biomarkers and mainly procalcitonin (PCT).

Connect with a study center

  • 2nd Propaedeutic Department of Internal Medicine, Attikon University Hospital

    Athens, Chaidari 12462
    Greece

    Active - Recruiting

  • 4th Department of Internal Medicine, Attikon University Hospital

    Athens, Chaidari 12462
    Greece

    Active - Recruiting

  • 1st Department of Internal Medicine, General Hospital of Elefsina "Thriasio"

    Athens, Elefsina 19600
    Greece

    Active - Recruiting

  • 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis

    Alexandroupolis,
    Greece

    Site Not Available

  • 1st Department of Internal Medicine - General Hospital of Athens Sismanoglio- Amalia Fleming

    Athens, 15126
    Greece

    Active - Recruiting

  • 1st Department of Internal Medicine, General Hospital of Athens KORGIALENIO-BENAKIO E.E.S.

    Athens, 11526
    Greece

    Active - Recruiting

  • 1st Department of Internal Medicine- General Hospital of Athens GENNIMATAS

    Athens, 11527
    Greece

    Active - Recruiting

  • 3rd Department of Internal Medicine - General State Hospital of Nikaia "Saint Panteleimon" - West Attica General Hospital "Agia Varvara"

    Athens, 18454
    Greece

    Active - Recruiting

  • 3rd University Department of Internal Medicine, Sotiria Athens General Hospital

    Athens, 11527
    Greece

    Active - Recruiting

  • 2nd Department of Internal Medicine, General Hospital of Piraeus "Tzaneio"

    Piraeus, 18536
    Greece

    Active - Recruiting

  • 1st University Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki

    Thessaloníki, 54636
    Greece

    Site Not Available

  • Intensive Care Unit, Ippokrateion General Hospital

    Thessaloníki, 54642
    Greece

    Site Not Available

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