Clinical Trial

Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis

Study acronym: BICCS
Recruiting Phase 4
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Summary
Patients hospitalized in ICU with sepsis (infection with life-threatening organ dysfunction according to sepsis 3.0 definitions) or septic shock presumably due to MDR-GNB (multidrug resistant Gram-negative bacteria). The study will be a prospective multicentre, randomized, open-label comparative continuous vs. intermittent pivotal βL (Beta Lactamine) antibiotic infusion strategies and combination vs. monotherapy trial conducted with a 2X2 factorial design.
Protocol Amendment History 22 amendments
This ClinicalTrials.gov record has been amended 22 times since 2022-12-26; most recent amendment 2026-02-24.
Status change: Active, Not Recruiting → Recruiting 2023-12-05
Status change: Not Yet Recruiting → Active, Not Recruiting 2023-11-14
Trial Details
NCT Number NCT05681442
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Sepsis
Enrollment 600 participants
Start Date 2023-11-13
Primary Completion 2027-01-04 (estimated)
Study Completion 2027-06-04 (estimated)
Updated on ClinicalTrials.gov 2026-02-27