Actively Recruiting
Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-27
600
Participants Needed
28
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (≥ 18 years)
- Hospital-acquired sepsis diagnosed within the last 24 hours
- Hospitalized for more than 48 hours or discharged less than 48 hours ago
- At least one risk factor for multidrug-resistant Gram-negative bacteria, including prior intravenous antibiotic use within 7 days (excluding certain antibiotics), prolonged hospital stay (≥ 15 days) within 3 months, prolonged mechanical ventilation (≥ 5 days) within 3 months, presence of indwelling devices, known colonization or infection with multidrug-resistant Gram-negative bacteria within 3 months, recent exposure to specific antibiotics within 3 months, recent travel to high-risk regions within 3 months, or urinary tract abnormalities in case of urinary infection
- Appropriate bacteriological samples taken before starting antimicrobial therapy
- Expected ICU stay longer than 3 days
You will not qualify if you...
- Known resistance to all proposed beta-lactams or to amikacin
- Need for extrarenal treatment at inclusion
- Known hypersensitivity to specified beta-lactam antibiotics or their excipients
- Severe hypersensitivity to other beta-lactam antibiotics or their excipients
- Known contraindications to aminoglycosides including hypersensitivity, advanced cirrhosis, myasthenia gravis, simultaneous aminoglycoside use, or association with ataluren
- Non-complicated urinary tract infection not causing sepsis
- Bone marrow transplant or chemotherapy-induced neutropenia
- Infections requiring long-term antibiotic treatment over 8 days
- Antibiotic treatment for new sepsis started before randomization exceeding specified doses or duration
- Limitation of life support measures at screening
- Participation in another interventional drug study
- Pregnancy or breastfeeding
- Legal restrictions such as being deprived of freedom or under legal protection
- No affiliation to any health insurance system
- Refusal to participate by patient or legal representative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Médecine intensive - réanimation - CHU Amiens-Picardie
Amiens, France, 80054
Withdrawn
2
Réanimation polyvalente - CH d'Argenteuil - Hôpital Victor Dupuy
Argenteuil, France, 95100
Actively Recruiting
3
Réanimation polyvalente - CH Avignon
Avignon, France, 84000
Actively Recruiting
4
Médecine intensive - réanimation - CHU Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33000
Actively Recruiting
5
Médecine intensive - réanimation - Ambroise Paré
Boulogne-Billancourt, France, 92100
Actively Recruiting
6
Médecine intensive - réanimation - CHU Gabriel Montpied
Clermont-Ferrand, France, 63003
Actively Recruiting
7
Anesthésie - Réanimation - Beaujon
Clichy, France, 92110
Actively Recruiting
8
Réanimation polyvalente/Surveillance continue - CH Sud Essonne-Etampes
Étampes, France, 91150
Actively Recruiting
9
Médecine intensive - réanimation-Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France, 85000
Actively Recruiting
10
Médecine intensive - réanimation - CHU Grenoble-Alpes Hôpital Michallon
La Tronche, France, 38700
Actively Recruiting
11
Réanimation polyvalente - CH de Versailles - Hôpital André Mignot
Le Chesnay, France, 78150
Actively Recruiting
12
Réanimation Médico Chirurgicale & USC - CH Le Mans
Le Mans, France, 72037
Actively Recruiting
13
Médecine Intensive Réanimation - Hôpital Croix Rousse
Lyon, France, 69004
Actively Recruiting
14
Médecine intensive - réanimation - HCL - Edouard Herriot
Lyon, France, 69437
Actively Recruiting
15
Réanimation polyvalente - CHR Metz-Thionville - Hôpital de Mercy
Metz, France, 57085
Actively Recruiting
16
Médecine intensive - réanimation - CHU Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
Actively Recruiting
17
Réanimation Chirurgicale - Saint Eloi
Montpellier, France, 34295
Actively Recruiting
18
Médecine Intensive Réanimation - Pasteur 2
Nice, France, 06100
Actively Recruiting
19
Médecine intensive - réanimation - CHU Nice - Hôpital Archet
Nice, France, 06202
Actively Recruiting
20
Médecine intensive - réanimation
Orléans, France, 45000
Actively Recruiting
21
Anesthésie - Réanimation - CHU Orléans
Orléans, France, 86000
Actively Recruiting
22
Médecine intensive et réanimation infectieuse - Bichat
Paris, France, 75018
Actively Recruiting
23
Réanimation chirurgicale - Bichat
Paris, France, 75018
Actively Recruiting
24
Institut Mutualiste du Montsouris
Paris, France
Actively Recruiting
25
Médecine intensive - réanimation - CHU Poitiers - Site de la Milétrie
Poitiers, France, 86000
Actively Recruiting
26
Médecine intensive et réanimation polyvalente 6 CHU de Reims - Hôpital Robert Debré
Reims, France, 51100
Withdrawn
27
Médecine intensive - réanimation-CH St Denis - Hôpital Delafontaine
Saint-Denis, France, 93200
Actively Recruiting
28
Médecine intensive - réanimation - CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67091
Actively Recruiting
Research Team
J
Jean-François TIMSIT, MD-PhD
CONTACT
L
Lila BOUADMA, MD-PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here