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A pHase III cluster randomIsed controlled, cross-over, non-inferiority Trial of a short course, High dose AntimicRobials vs conventional dose and Duration in critically ill patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514730-21-00
Enrollment
1282
Registered
2025-04-18
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-09-05

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

Conditions

Bacterial infections and mycoses

Brief summary

All-cause mortality within 90 days after inclusion.

Detailed description

All-cause ICU mortality., All-cause hospital mortality., New colonization or infection with a multi-resistant organism (MRSA, VRE, MDR P. aeruginosa, CRE, ESBL Enterobacterales, Acinetobacter baumannii) or C. difficile diarrhea/infection up to 28 days post inclusion., Antimicrobial free days., Recurrence of infection., Toxicity., Health related quality of life (EQ-5D-5L measured at D90)., Exposure., Clinical cure, 10. ICU length of stay, 11. Hospital length of stay, 12. Organ support free days, 13. DDDs and DOTs

Interventions

DRUGMEROPENEM
DRUGPIPERACILLIN AND BETA-LACTAMASE INHIBITOR
DRUGCEFUROXIME
DRUGCEFTRIAXONE
DRUGCEFOTAXIME

Sponsors

Universitair Ziekenhuis Gent
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
All-cause mortality within 90 days after inclusion.—

Secondary

MeasureTime frame
All-cause ICU mortality., All-cause hospital mortality., New colonization or infection with a multi-resistant organism (MRSA, VRE, MDR P. aeruginosa, CRE, ESBL Enterobacterales, Acinetobacter baumannii) or C. difficile diarrhea/infection up to 28 days post inclusion., Antimicrobial free days., Recurrence of infection., Toxicity., Health related quality of life (EQ-5D-5L measured at D90)., Exposure., Clinical cure, 10. ICU length of stay, 11. Hospital length of stay, 12. Organ support free days, 13. DDDs and DOTs—

Countries

Belgium, Netherlands

Outcome results

None listed

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