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ACTIVE NOT RECRUITING
NCT05909683
PHASE3

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

Sponsor: Hellenic Institute for the Study of Sepsis

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2023-09-19

Completion Date

2026-04-15

Last Updated

2026-01-16

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

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

After the patient's blood flask is flagged positive for bloodstream infection, the blood sample will be assessed in the BCID2 diagnostic test in order to identify the underlying pathogens the patient is infected with. After the identification, and in the presence of gram-negative bacteria, the sample will be assessed in the Reveal Rapid AST test to provide information about which antimicrobials the specific pathogens are sensitive to. When both the identification of the pathogen and the sensitivities are available, the central laboratory will inform the attending physicians, who are obliged to change the standard of care antimicrobial therapy administered based on the rule in Box1 of the protocol. Finally, based on the results of the procalcitonin (PCT) on the first day by day 5 when PCT value is less than 80% of the initial value or it remains below 0.5 ng/ml, the attending physicians should discontinue the antimicrobial therapy.

OTHER

Standard of Care

Standard of care practices of the specific study site. Antimicrobials will be administered based on the attending physicians' critical opinion, and discontinuation will be done based on the standard procedures of the study site.

Locations (15)

Intensive Care Unit of Center for Respiratory Failure, Sotiria Chest Diseases Athens General Hospital

Athens, Attica, Greece

New Multivalent Intensive Care Unit, Sotiria Chest Diseases Athens General Hospital

Athens, Attica, Greece

2nd Propaedeutic Department of Internal Medicine, Attikon University Hospital

Athens, Chaidari, Greece

4th Department of Internal Medicine, Attikon University Hospital

Athens, Chaidari, Greece

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

Athens, Elefsina, Greece

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

Alexandroupoli, Greece

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

Athens, Greece

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

Athens, Greece

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

Athens, Greece

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

Athens, Greece

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

Athens, Greece

Clinic of Intensive Care and Pulmonary Diseases, Aghioi Anargyroi Kifissia General Oncologic Hospital

Kifissia, Greece

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

Piraeus, Greece

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

Thessaloniki, Greece

Intensive Care Unit, Ippokrateion General Hospital

Thessaloniki, Greece