AG infusion for 5 days / continuous pivotal βL-AB / AG infusion most 1 dose · Phase 4 Trial
ClinicalTrials.gov · September 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for a Phase 4 multicentre factorial randomized trial comparing continuous versus intermittent beta-lactam infusion and monotherapy versus combination aminoglycoside therapy in ICU patients with hospital-acquired sepsis due to multidrug-resistant Gram-negative bacteria. No results are posted in this record; the study is active but no longer recruiting.
Phase 4, Interventional, Randomized, Parallel, Open label, Treatment purpose. Sepsis; age from 18 Years. Intervention: continuous infusion dosing of a pivotal AND AG infusion for…; intermittent infusion dosing of a pivotal βL-AB ND AG infus…; continuous infusion dosing of a pivotal βL-AB AND AG infusi…; intermittent infusion dosing of a pivotal βL-AB AND A…. Compared with: Intermittent pivotal beta-lactam antibiotic infusion and/or aminoglycoside infusion for a single dose. n = 600. 26 sites: France.
This is a registry record for a Phase 4 multicentre factorial randomized trial comparing continuous versus intermittent beta-lactam infusion and monotherapy versus combination aminoglycoside therapy in ICU patients with hospital-acquired sepsis due to multidrug-resistant Gram-negative bacteria. No results are posted in this record; the study is active but no longer recruiting.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a clinical trial registry record with no reported results; the study is active but not yet recruiting-complete, and outcomes have not been posted.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05681442). This is a study registration, not published results. Lead sponsor: Assistance Publique - Hôpitaux de Paris. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 600 participants (ESTIMATED). Conditions: Sepsis. Interventions: DRUG: continuous pivotal βL-AB; DRUG: intermittent pivotal βL-AB; DRUG: AG infusion most 1 dose; DRUG: AG infusion for 5 days. Primary outcome measures: To compare the 30-day mortality of patients with hospital-acquired sepsis in the ICU , 30 days after acquiring sepsis. Brief 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.
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