Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in
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. intermit
| Condition(s) | Sepsis |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Adults (≥ 18 years) * Hospital-acquired sepsis (according to sepsis 3.0 definitions) : * Patient hospitalized for more than 48 hours OR Patient discharged less than 48 hours ago * AND sepsis diagnosed within the last 24 hours * One of the following risk factors for gram negative multidrug resistant pathogens: * Prior intravenous antibiotic use within 7 days prior to sepsis onset with the exception of antibiotic effective only against Gram-positive bacteria, penicillin A and macrolides * Prolonged hospital stay (≥ 15 days of hospitalization) within 3 months prior to sepsis onset Prolonged mechanical ventilation (≥ 5 days on mechanical ventilation) within 3 months prior to sepsis onset * Patients with indwelling devices (dialysis access lines, intravascular lines, urina |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Locations | Amiens, France; Argenteuil, France; Avignon, France; Bordeaux, France; Boulogne-Billancourt, France; Clermont-Ferrand, France (+22 more sites) |
| Start date | 2023-11-13 |
| NCT ID | NCT05681442 |
| Official listing | https://clinicaltrials.gov/study/NCT05681442 |