An observational study in Severe Infection, sponsored by Fondation Hôpital Saint-Joseph. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by Fondation Hôpital Saint-Joseph · Observational
Since the discovery of streptomycin in 1944, aminoglycosides retain a remarkable bactericidal activity vis-à-vis including aerobic gram-negative bacilli. Thus, their synergistic effect with beta-lactams and their rapid bactericidal on many make unavoidable pathogens and make it a cornerstone of the treatment of patients with severe sepsis or state of septic shock.
This is antibiotics exclusively parenteral administration. Their effectiveness is concentration-dependent and are administered by 30-minute infusion. Tolerance of venous is usually excellent. Their potential nephrotoxicity or cochleovestibular toxicity requires accurate monitoring of antibiotic residuals.
Moreover the fact that the effectiveness of the aminoglycosides is concentration dependent, the rate at the peak is decisive. A first sub-therapeutic dose leads to adaptively resistant bacteria compared to the aminoglycoside and therefore an increase of Minimal Inhibitory Concentrations (MIC). Many studies have been conducted in patients hospitalized in intensive care, highlighting underdoses in aminoglycosides when the prescribed dosages consistent with those used in non reanimated patients. Dr Moore showed in 89 ICU patients with bacteremia gram-negative bacilli, the relationship between the clinical course and obtaining whether therapeutic levels during the first administration of aminoglycosides. Thus, mortality in patients whose antibiotic concentrations to peak were subtherapeutic, amounted to 20.9% against 2.4% when concentrations were within the therapeutic range. In the context or an initial peak in the PK / PD ( Pharmacokinetic / Pharmacodynamic) objectives namely Cmax / MIC ≥ 8-10 desirable, individualized therapeutic drug monitoring and identification of factors that may cause a concentration of antibiotic at sub-therapeutic peak seems necessary , in patients for the majority an increased volume of distribution.
In addition to the β-lactams and glycopeptides, due to the increased volume of distribution in critically ill patients in sepsis, evaluation of serum 24 hours after starting treatment to check that the PK / PD goals for these molecules is achieved.
Primary / secondary objective
Investigators propose to conduct a study with the goal:
Evaluate the rate of patients for whom PK / PD efficiency target for related antibiotics is reached:
Methodology :
Data Monitoring and support:
Patient data will be collected on a computer CRF including clinical, biological and microbiological data of patients via the patient's medical record on DXcare: demographics, weight, height, BMI, hydration status, kidney function, liver function, shock, chronic heart failure, malnutrition, hypoalbuminemia burned, cirrhosis, chronic rheumatic disease, other antecedents, pregnancy, reason for hospitalization, etiology of sepsis motivating the introduction of aminoglycosides, β-lactam or glycopeptide and also other associated treatments. The data collected will help identify risk factors associated with a sub-therapeutic dosing aminoglycosides, β-lactam or glycopeptide.
Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult patients ≥ 18 years admitted to the intensive care unit of GH Paris Saint-Joseph and who will prescribe the entrance or during their stay an aminoglycoside treatment for severe infection
Exclusion Criteria:
Evaluation of Pharmacokinetic / Pharmacodynamic Data and Interest Individualized Therapeutic Drug Monitoring Glycopeptides and β-lactam-aminoglycoside ICU
Assessment of Pharmacokinetic Glycopeptides Cmax
Evaluate the rate of patients for whom the objective of efficiency PK / PD Cmax / MIC ≥ 8-10 is reached at the first dose of the usual doses
Time frame: 30 minutes after first injection
Assessment of Pharmacodynamic Glycopeptides Cmax
Evaluate the rate of patients for whom the objective of efficiency PK / PD Cmax / MIC ≥ 8-10 is reached at the first dose of the usual doses
Time frame: 30 minutes after first injection
Assessment of Pharmacokinetic β-lactam-aminoglycoside Cmax
Evaluate the rate of patients for whom the objective of efficiency PK / PD Cmax / MIC ≥ 8-10 is reached at the first dose of the usual doses
Time frame: 30 minutes after first injection
Assessment of Pharmacodynamic β-lactam-aminoglycoside Cmax
Evaluate the rate of patients for whom the objective of efficiency PK / PD Cmax / MIC ≥ 8-10 is reached at the first dose of the usual doses
Time frame: 30 minutes after first injection
Mortality rate
Compare the 30-day mortality among patients with subclinical a first rate versus those who have reached the desired peak
Time frame: Day 30
Assess the residual of Glycopeptides
Assess the residual to 12h after injection to an anticipation of residual dosed at 24.
Time frame: Hour 12 and Hour 24 after injection
Assess the residual of β-lactam-aminoglycoside
Assess the residual to 12h after injection to an anticipation of residual dosed at 24.
Time frame: Hour 12 and Hour 24 after injection
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Fondation Hôpital Saint-Joseph