RECRUITINGPhase 4INTERVENTIONAL
Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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,
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Exclusion Criteria:
* 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)
Treatments Being Tested
DRUG
continuous pivotal βL-AB
continuous pivotal βL-AB
DRUG
intermittent pivotal βL-AB
intermittent pivotal βL-AB (IID = control group)
DRUG
AG infusion most 1 dose
AG infusion most 1 dose (AMT group )
DRUG
AG infusion for 5 days
AG infusion for 5 days (ACT Group)
Locations (20)
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