Informations générales (source: ClinicalTrials.gov)
Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis
Interventional
Phase 4
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
novembre 2023
décembre 2025
17 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE HOSPITALIER DE ST-DENIS | TIMSIT Jean-françois | 18/09/2025 17:27:15 | Contacter | ||
| CH VICTOR DUPOUY ARGENTEUIL | TIMSIT Jean-françois | 18/09/2025 17:27:15 | Contacter | ||
| CH DE VERSAILLES SITE ANDRE MIGNOT | TIMSIT Jean-françois | 18/09/2025 17:27:14 | Contacter | ||
| CH SUD ESSONNE-DOURDAN-ETAMPES | TIMSIT Jean-françois | 18/09/2025 17:27:15 | Contacter | ||
| INSTITUT MUTUALISTE MONTSOURIS | TIMSIT Jean-françois | 18/09/2025 17:27:15 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/09/2025 17:27:15 | Contacter | |||
| AP-HP - Hôpital Ambroise Paré | |||||
| AP-HP - Hôpital Beaujon | |||||
| AP-HP - Hôpital Bichat | |||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:15 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:15 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:27:15 | Contact (sur clinicalTrials) | ||||
| Réanimation polyvalente - CH de Versailles - Hôpital André Mignot - 78150 - Le Chesnay - France | Gilles TROCHE, MD - PhD | 18/09/2025 17:27:14 | Contact (sur clinicalTrials) | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Anesthésie - Réanimation - CHU Orléans - 86000 - Orléans - France | BARBIER François | Contact (sur clinicalTrials) | |||
| Institut Mutualiste du Montsouris - Paris - France | WICKY P Paul-Henri | Contact (sur clinicalTrials) | |||
| Médecine intensive - réanimation - 45000 - Orléans - France | Contact (sur clinicalTrials) | ||||
| Médecine intensive - réanimation - Ambroise Paré - 92100 - Boulogne-Billancourt - France | Antoine VIELLARD-BARON, MD-PhD | Contact (sur clinicalTrials) | |||
| Médecine intensive - réanimation - CHU Amiens-Picardie - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Médecine intensive - réanimation - CHU Bordeaux - Hôpital Pellegrin - 33000 - Bordeaux - France | Alexandre BOYER, MD - PhD | Contact (sur clinicalTrials) | |||
| Médecine intensive - réanimation - CHU de Strasbourg - Nouvel Hôpital Civil - 67091 - Strasbourg - France | Ferhat MEZIANI, MD - PhD | Contact (sur clinicalTrials) | |||
| Médecine intensive - réanimation - CHU Gabriel Montpied - 63003 - Clermont-Ferrand - France | Claire DUPUIS, MD - Phd | Contact (sur clinicalTrials) | |||
| Médecine intensive - réanimation - CHU Grenoble-Alpes Hôpital Michallon - 38700 - La Tronche - France | Anais DARTEVEL, MD - PhD | Contact (sur clinicalTrials) | |||
| Médecine intensive - réanimation - CHU Montpellier - Hôpital Lapeyronie - 34295 - Montpellier - France | Kada KLOUCHE, MD - PhD | Contact (sur clinicalTrials) | |||
| Médecine intensive - réanimation - CHU Nice - Hôpital Archet - 06202 - Nice - France | Clément SACCHERI, MD - PhD | Contact (sur clinicalTrials) | |||
| Médecine intensive - réanimation - CHU Poitiers - Site de la Milétrie - 86000 - Poitiers - France | François ARRIVE, MD - PhD | Contact (sur clinicalTrials) | |||
| Médecine intensive - réanimation - HCL - Edouard Herriot - 69437 - Lyon - France | Laurent ARGAUD, MD-PhD | Contact (sur clinicalTrials) | |||
| Médecine intensive - réanimation-Centre Hospitalier Départemental Vendée - 85000 - La Roche-sur-Yon - France | Konstantinos BACHOUMAS, MD - PhD | Contact (sur clinicalTrials) | |||
| Médecine intensive - réanimation-CH St Denis - Hôpital Delafontaine - 93200 - Saint-Denis - France | Daniel DA SILVA, MD - PhD | Contact (sur clinicalTrials) | |||
| Médecine intensive et réanimation polyvalente 6 CHU de Reims - Hôpital Robert Debré - 51100 - Reims - France | Bruno MOURVILLIER, MD- PhD | Contact (sur clinicalTrials) | |||
| Médecine Intensive Réanimation - Hôpital Croix Rousse - 69004 - Lyon - France | Jean-christophe RICHARD | Contact (sur clinicalTrials) | |||
| Médecine Intensive Réanimation - Pasteur 2 - 06100 - Nice - France | ROBERT Alexandre | Contact (sur clinicalTrials) | |||
| Réanimation Chirurgicale - Saint Eloi - 34295 - Montpellier - France | Samir JABER | Contact (sur clinicalTrials) | |||
| Réanimation Médico Chirurgicale & USC - CH Le Mans - 72037 - Le Mans - France | Cédric DARREAU, MD - PhD | Contact (sur clinicalTrials) | |||
| Réanimation polyvalente - CH Avignon - 84000 - Avignon - France | Sébastien MOSSCHIETTO, MD - PhD | Contact (sur clinicalTrials) | |||
| Réanimation polyvalente - CH d'Argenteuil - Hôpital Victor Dupuy - 95100 - Argenteuil - France | Olivier PAJOT, MD-PhD | Contact (sur clinicalTrials) | |||
| Réanimation polyvalente - CHR Metz-Thionville - Hôpital de Mercy - 57085 - Metz - France | Guillaume LOUIS, MD - PhD | Contact (sur clinicalTrials) | |||
| Réanimation polyvalente/Surveillance continue - CH Sud Essonne-Etampes - 91150 - Étampes - France | Shidasp SIAMI, MD-PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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,
urinary catheter, endotracheal or tracheostomy tube, gastrostomy or jejunostomy
feeding tube)
- Patients known to be infected, colonized or carriers of MDR gram negative
bacteria within 3 months prior to sepsis onset
- Exposure to an antibiotic (amoxicillin-clavulanic acid, C2G, C3G,
fluoroquinolones) within 3 months prior to sepsis onset
- A trip abroad to known geographical areas at risk (in particular the Indian
subcontinent, South-East Asia, the Middle East and North Africa, the
Mediterranean Basin) within 3 months prior to sepsis onset
- A functional or organic abnormality of the urinary tract in case of urinary
tract infection.
- Appropriate bacteriological sampling performed before starting antimicrobial therapy
- Expected stay in ICU of more than 3 days
- 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,
urinary catheter, endotracheal or tracheostomy tube, gastrostomy or jejunostomy
feeding tube)
- Patients known to be infected, colonized or carriers of MDR gram negative
bacteria within 3 months prior to sepsis onset
- Exposure to an antibiotic (amoxicillin-clavulanic acid, C2G, C3G,
fluoroquinolones) within 3 months prior to sepsis onset
- A trip abroad to known geographical areas at risk (in particular the Indian
subcontinent, South-East Asia, the Middle East and North Africa, the
Mediterranean Basin) within 3 months prior to sepsis onset
- A functional or organic abnormality of the urinary tract in case of urinary
tract infection.
- Appropriate bacteriological sampling performed before starting antimicrobial therapy
- Expected stay in ICU of more than 3 days
- A priori known resistance to all the proposed beta-lactams or to amikacin
- Need for extrarenal treatment at inclusion according to the criteria of Gaudry et
al.
- Known hypersensitivity to ceftazidime, piperacillin-tazobactam, cefepime, meropenem,
ceftazidime-avibactam, ceftazolane-avibactam or to any of the excipients included in
the corresponding pharmaceutical drugs,
- Known hypersensitivity to any cephalosporin antibacterial agent,
- Know hypersentitivity to any penem antibacterial agent,
- Severe known hypersensitivity (eg, anaphylactic reaction, severe skin reaction) to
any other beta-lactam antibiotic (eg, penicillins or monobactam ) or to any of its
excipients.
- Known contraindication to the aminoglycoside family including
- Hypersensitivity to the active substance, to any aminoglycoside antibacterial
agent or to any of the excipients included in the corresponding pharmaceutical
drugs,
- Cirrhosis of grades B and C according to the Child-Pugh classification.
- Myasthenia gravis.
- Simultaneous administration of another aminoglycoside
- Association with ataluren
- Non-complicated urinary tract infection (corresponding to a positive ECBU not
responsible for sepsis)
- Bone marrow transplant or chemotherapy-induced neutropenia
- Infections for which long-term antibiotic treatment > 8 days is strongly recommended
(i.e., infective endocarditis, osteoarticular infections, anterior mediastinitis
after cardiac surgery, hepatic or cerebral abscesses, chronic prostatitis for
instance
- Presence of antibiotic therapyfor the new sepsis before randomisation: (> 2 doses of
antibiotics or > 16h for continuous infusion
- Limitation of life support (comfort care applied only) at the time of screening
- Enrolment to another interventional drug study
- Pregnancy or breastfeeding
- Subject deprived of freedom, subject under a legal protective measure
- Non affiliation to any health insurance system
- Refusal to participate to the study (patient or legal representative or family
member or close relative if present)