RecruitingPhase 4NCT05681442

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

600 participants

Start Date

Nov 13, 2023

Study Type

INTERVENTIONAL

Conditions

Sepsis

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods of giving beta-lactam antibiotics (intermittent vs. continuous infusion) with or without an additional antibiotic (amikacin) in adult ICU patients with hospital-acquired sepsis caused by or suspected to involve resistant bacteria. The goal is to find the best antibiotic strategy to fight serious infections. **You may be eligible if...** - You are at least 18 years old - You developed sepsis (a life-threatening infection response) while already in the hospital for more than 48 hours - You have at least one risk factor for drug-resistant bacteria (e.g., prior IV antibiotics, long hospital stays, indwelling medical devices, or recent international travel) - You are expected to be in the ICU for more than 3 days **You may NOT be eligible if...** - You are known to have bacteria resistant to all the study antibiotics - You have severe kidney disease requiring dialysis at the time of enrollment - You are pregnant or breastfeeding - You have a known allergy to beta-lactam or aminoglycoside antibiotics - You have myasthenia gravis - You are enrolled in another drug study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcontinuous pivotal βL-AB

continuous pivotal βL-AB

DRUGintermittent pivotal βL-AB

intermittent pivotal βL-AB (IID = control group)

DRUGAG infusion most 1 dose

AG infusion most 1 dose (AMT group )

DRUGAG infusion for 5 days

AG infusion for 5 days (ACT Group)

Locations(28)

Médecine intensive - réanimation - CHU Amiens-Picardie

Amiens, France

Réanimation polyvalente - CH d'Argenteuil - Hôpital Victor Dupuy

Argenteuil, France

Réanimation polyvalente - CH Avignon

Avignon, France

Médecine intensive - réanimation - CHU Bordeaux - Hôpital Pellegrin

Bordeaux, France

Médecine intensive - réanimation - Ambroise Paré

Boulogne-Billancourt, France

Médecine intensive - réanimation - CHU Gabriel Montpied

Clermont-Ferrand, France

Anesthésie - Réanimation - Beaujon

Clichy, France

Réanimation polyvalente/Surveillance continue - CH Sud Essonne-Etampes

Étampes, France

Médecine intensive - réanimation-Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Médecine intensive - réanimation - CHU Grenoble-Alpes Hôpital Michallon

La Tronche, France

Réanimation polyvalente - CH de Versailles - Hôpital André Mignot

Le Chesnay, France

Réanimation Médico Chirurgicale & USC - CH Le Mans

Le Mans, France

Médecine Intensive Réanimation - Hôpital Croix Rousse

Lyon, France

Médecine intensive - réanimation - HCL - Edouard Herriot

Lyon, France

Réanimation polyvalente - CHR Metz-Thionville - Hôpital de Mercy

Metz, France

Médecine intensive - réanimation - CHU Montpellier - Hôpital Lapeyronie

Montpellier, France

Réanimation Chirurgicale - Saint Eloi

Montpellier, France

Médecine Intensive Réanimation - Pasteur 2

Nice, France

Médecine intensive - réanimation - CHU Nice - Hôpital Archet

Nice, France

Médecine intensive - réanimation

Orléans, France

Anesthésie - Réanimation - CHU Orléans

Orléans, France

Médecine intensive et réanimation infectieuse - Bichat

Paris, France

Réanimation chirurgicale - Bichat

Paris, France

Institut Mutualiste du Montsouris

Paris, France

Médecine intensive - réanimation - CHU Poitiers - Site de la Milétrie

Poitiers, France

Médecine intensive et réanimation polyvalente 6 CHU de Reims - Hôpital Robert Debré

Reims, France

Médecine intensive - réanimation-CH St Denis - Hôpital Delafontaine

Saint-Denis, France

Médecine intensive - réanimation - CHU de Strasbourg - Nouvel Hôpital Civil

Strasbourg, France

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