Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis (NCT05681442) | Clinical Trial Compass
RecruitingPhase 4
Beta-lactam Intermittent Versus Continuous Infusion and Combination Antibiotic Therapy in Sepsis
France600 participantsStarted 2023-11-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 per…
What they're measuring
1
To compare the 30-day mortality of patients with hospital-acquired sepsis in the ICU