A Phase 3 interventional study of Change of antimicrobials based on BCID2 and Reveal Rapid AST tests. Stop of antimicrobials based on PCT results. and Standard of Care in Sepsis, sponsored by Hellenic Institute for the Study of Sepsis. Active, not recruiting at 15 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Hellenic Institute for the Study of Sepsis · Phase 3, Interventional, and Diagnostic
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.
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).
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 190 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Hellenic Institute for the Study of Sepsis is the lead sponsor of 31 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
These patients will receive antibiotics according to standard practice of the attending physicians. The central lab will feedback to attending physicians and investigators the results of the conventional blood cultures and AST according to the routine SOP. The attending physicians and investigators will be allowed to decide for any change of antimicrobial treatment based on the results of conventional blood cultures provided to them by the central lab or any other culture provided to them by their hospital. Antibiotics will be stopped according to the local standard practice. BCID2, Reveal Rapid AST and PCT will be performed in the samples of these patients, attending physicians will not be provided such information.
Other: Standard of Care
These patients will start antibiotics according to standard practice of the attending physicians. It is anticipated that attending physicians will be informed in maximum 5 hours after randomization about the results of BCID2 including carriage of resistance genes and of the Reveal Rapid AST in the case of Gram-negative isolates. Physicians and investigators receiving this information are obliged to change the empirically prescribed antibiotics according to the rule provided in Box 1. The attending physicians and investigators will be allowed to decide for any change of antimicrobial treatment based on the results of conventional blood cultures provided to them by the central lab or any other culture provided to them by their hospital. PCT will be measured on day 1 and then daily starting from day 5. Attending physicians will be advised to discontinue antimicrobials 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.
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.
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.
The number of days under treatment with broad-spectrum antibiotics in the group receiving the MODIFY strategy compared to patients treated by standard of care.
The number of days under treatment with broad-spectrum antibiotics in the group receiving the MODIFY strategy compared to patients treated by standard of care.
Time frame: Through study completion, an average of 2 years
Time to first change of antimicrobial modification
Time to first change of antimicrobial modification
Time frame: Through study completion, an average of 2 years
Time to the first sterile blood culture
Time to the first sterile blood culture
Time frame: Through study completion, an average of 2 years
The number of patients in whom no changes in administered antibiotics will apply.
The number of patients in whom no changes in administered antibiotics will apply.
Time frame: Through study completion, an average of 2 years
At least 2-point decrease of baseline SOFA (Sequential organ failure assessment) score by day 7
At least 2-point decrease of baseline SOFA (Sequential organ failure assessment) score by day 7. SOFA ranges between 0-24 and the higher the score, the worst the outocome of the patient.
Time frame: Through study completion, an average of 2 years
28-day mortality
28-day mortality
Time frame: Through study completion, an average of 2 years
90-day mortality
90-day mortality
Time frame: Through study completion, an average of 2 years
Incidence of laboratory documented Clostrioides difficile infection
Incidence of laboratory documented Clostrioides difficile infection
Time frame: Through study completion, an average of 2 years
Length of hospital stay
Length of hospital stay
Time frame: Through study completion, an average of 2 years
Cost of hospitalization
Cost of hospitalization
Time frame: Through study completion, an average of 2 years
Time to escalation of antibiotics
Time to escalation of antibiotics
Time frame: Through study completion, an average of 2 years
Time to de-escalation of antibiotics
Time to de-escalation of antibiotics
Time frame: Through study completion, an average of 2 years
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Hellenic Institute for the Study of Sepsis