CHU Clermont-Ferrand
Clermont-Ferrand, 63000, France
NCT Number: NCT04070469
Amoxicillin is the most prescribed antibiotic in France. High dose intravenous amoxicillin, (dosage greater than or equal to 150 mg / kg / day or 12 g per day for patients over 80 kg) is used in the treatment, in particular, of infectious streptococcal endocarditis. oral, streptococci gallolyticus and enterococci, infections of the central nervous system with sensitive germs including Streptococcus pneumoniae and Listeria monocytogenes, osteo articular infections. The dose-related adverse effects of this antibiotic are nephrological (crystalluria may lead to acute renal failure) and neurologic. Recently, the number of amoxicillin crystalluria reported to pharmacovigilance centers has increased, having led the National Agency of drug and health products safety (ANSM) to recommend the determination of the residual level of amoxicillin during the first week of treatment of these patients. Nevertheless, there is no precise therapeutic target in patients treated with high dose amoxicillin except in the context of critical care. The authors suggest the interest of a target between 4 and 10 times the minimum inhibitory concentration (MIC) based on in vitro efficacy studies, and retrospective observations of toxicity cases.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Clermont-Ferrand, 63000, France
Patients will be followed for 8 days. After inclusion, (day of the introduction of high-dose amoxicillin treatment), the residual amoxicillin plasma concentrations will be determined at Day1, Day4 +/- 1 day and Day7 +/- 1 day of the start of treatment. A urine collection will be performed the same day to search for crystalluria and measure the pH and urinary density.
In case of KDIGO (Kidney Disease Improving Global Outcomes) 2 or 3 stage renal failure or neurological signs compatible with overdose, residual amoxicillin and crystalluria and urinary density and urinary pH will be measured during the day of discovery of renal failure.
In the case of KDIGO stage 1 kidney failure, a residual level of amoxicillin and a crystalluria search and the measurement of urinary density and urinary pH will be carried out the following day, when serum creatinine is checked according to usual practices.
At day 7 the clinical and infectious biological evolution of the patient will be collected.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
dosage of plasma concentration of amoxicillin
Other names: amoxicillin treatment
Time frame: Day 7
research of Residual plasma concentrations of amoxicillin
Time frame: Day 4
research of Residual plasma concentrations of amoxicillin
Time frame: Day 1
research of Residual plasma concentrations of amoxicillin
Time frame: Day 7
research in fresh morning urine sample, examined by microscope then infrared spectroscopy in case of crystalluria
Time frame: Day 4
research in fresh morning urine sample, examined by microscope then infrared spectroscopy in case of crystalluria
Time frame: Day 1
research in fresh morning urine sample, examined by microscope then infrared spectroscopy in case of crystalluria
Time frame: day 7
plasma concentrations on blood sample
Time frame: day 4
plasma concentrations on blood sample
Time frame: day 1
plasma concentrations on blood sample
Time frame: Day 7
research in fresh morning urine sample
Time frame: Day 7
research in fresh morning urine sample
Time frame: Day 4
research in fresh morning urine sample
Time frame: Day 4
research in fresh morning urine sample
Time frame: Day 1
research in fresh morning urine sample
Time frame: Day 1
research in fresh morning urine sample
Time frame: Day 1
Glasgow coma scale
Time frame: Day 4
Glasgow coma scale
Time frame: Day 7
Glasgow coma scale
Time frame: Day 1
focal neurological signs
Time frame: Day 4
focal neurological signs
Time frame: Day 7
focal neurological signs
Time frame: Day 1
abnormal movement disorders, seizures and status epilepticus
Time frame: Day 4
abnormal movement disorders, seizures and status epilepticus
Time frame: Day 7
abnormal movement disorders, seizures and status epilepticus
Time frame: Day 0
in years
Time frame: Day 0
weight in kg and height in meters will be combined to report BMI in kg/m^2
Time frame: Day 0
CKD EPI clearance, based on serum creatinine in µmol/L
Time frame: Day 1
stage of acute kidney injury (based on KDIGO guidelines using variation of serum creatinine in µmol/L compared with baseline, and measure of urine output)
Time frame: Day 4
stage of acute kidney injury (based on KDIGO guidelines using variation of serum creatinine in µmol/L compared with baseline, and measure of urine output)
Time frame: Day 7
stage of acute kidney injury (based on KDIGO guidelines using variation of serum creatinine in µmol/L compared with baseline, and measure of urine output)
Time frame: Day 0
full name of bacteria
Time frame: Day 0
MIC in mg/L
Time frame: Day 0
infected organs
University Hospital, Clermont-Ferrand
Other
Plasma Concentrations of Amoxicillin Administered in High-doses During the First Week of Treatment : Intra- and Inter-individual Variability, Factors Associated With Overdose and Adverse Events
Acronym: MAX-AMOX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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