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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502962-26-00
Acronym
MODIFY
Enrollment
190
Registered
2023-04-27
Start date
2023-09-14
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe infections

Brief summary

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.

Detailed description

Time to first change of antibiotics, Time to the first sterile blood culture, Maintenance of the same antimicrobial(s) in case of activity against the pathogen, At least 2-point decrease of baseline SOFA score by day 7, 28-day mortality, 90-day mortality, Incidence of laboratory documented Clostrioides difficile infection, Length of hospital stay, Cost of hospitalization, Time to escalation of antibiotics, Time to de-escalation of antibiotics

Interventions

DRUGMICAFUNGIN
DRUGVABORBACTAM
DRUGLINEZOLID
DRUGVANCOMYCIN
DRUGCEFTRIAXONE
DRUGTEICOPLANIN
DRUGIMIPENEM
DRUGANIDULAFUNGIN
DRUGCEFTAZIDIME
DRUGMEROPENEM
DRUGCEFUROXIME

Sponsors

Hellenic Institute For The Study Of Sepsis
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Time to first change of antibiotics, Time to the first sterile blood culture, Maintenance of the same antimicrobial(s) in case of activity against the pathogen, At least 2-point decrease of baseline SOFA score by day 7, 28-day mortality, 90-day mortality, Incidence of laboratory documented Clostrioides difficile infection, Length of hospital stay, Cost of hospitalization, Time to escalation of antibiotics, Time to de-escalation of antibiotics

Countries

Greece

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026