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

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients hospitalized in ICU with sepsis (infection with life-threatening organ dysfunction according to sepsis 3.0 definitions) 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Criteria

Inclusion Criteria:

• Adults (≥ 18 years)

• Hospital-acquired sepsis diagnosed in the past 24 hours (according to sepsis 3.0 definitions)

• One of the following risk factors for 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 90 days prior to the occurrence of sepsis

• Prolonged mechanical ventilation (≥ 5 days on mechanical ventilation) within 90 days prior to sepsis onset

• Patients with indwelling devices (dialysis access lines, intravascular lines, urinary catheter, endotracheal or tracheostomy tube, gastrostomy or jejunostomy feeding tube)

• Patients known to be infected, colonized or carriers of MDR gram negative bacteria in the past 3 months

• Appropriate bacteriological sampling performed before starting antimicrobial therapy

• Expected stay in ICU of more than 3 days

Exclusion Criteria:

• Knowledge of the germ of inclusion infection resistant to all the proposed beta-lactams or resistant to amikacin

• Need for extrarenal treatment at inclusion according to the criteria of Gaudry et al.

• Known allergy to amikacin

• Known allergy to βL

• Non-complicated urinary tract infection (with the exception of acute prostatitis)

• Bone marrow transplant or chemotherapy-induced neutropenia