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

PHASE3RecruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

September 19, 2023

Primary Completion Date

December 27, 2026

Study Completion Date

December 27, 2026

Conditions
Sepsis
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.

Trial Locations (15)

11526

RECRUITING

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

11527

RECRUITING

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

RECRUITING

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

RECRUITING

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

RECRUITING

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

12462

RECRUITING

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

RECRUITING

4th Department of Internal Medicine, Attikon University Hospital, Athens

14564

RECRUITING

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

15126

NOT_YET_RECRUITING

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

18454

RECRUITING

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

18536

RECRUITING

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

19600

RECRUITING

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

54636

NOT_YET_RECRUITING

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

54642

NOT_YET_RECRUITING

Intensive Care Unit, Ippokrateion General Hospital, Thessaloniki

Unknown

NOT_YET_RECRUITING

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

All Listed Sponsors
lead

Hellenic Institute for the Study of Sepsis

OTHER