Plasma Concentrations of Amoxicillin Administered in High-doses During the First Week of Treatment (MAX-AMOX)
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
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.