Status:
COMPLETED
Plasma Concentrations of Amoxicillin Administered in High-doses During the First Week of Treatment (MAX-AMOX)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Infection, Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 t...
Detailed Description
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 +/-...
Eligibility Criteria
Inclusion
- Major patient, male or female, who has a bacterial infection requiring high dose intravenous amoxicillin antibiotic therapy (greater than or equal to 150 mg / kg / day with a maximum of 12 grams per day or 12 grams per day for patients over 80 kg), according to ANSM recommendations.
- Able to provide informed consent to participate.
- Covered by a Social Security scheme.
Exclusion
- Pregnant, breastfeeding, or likely to be pregnant women and in the absence of a negative pregnancy test (blood HCG beta).
- Patients under guardianship, curatorship, deprived of liberties or subject to a safeguard of justice.
- Septic shock justifying treatment with pressurized amines.
- Patient under ventilatory or circulatory support.
- Patients on dialysis at Baseline or with a creatinin clearance less than or equal to 30mL / min
- Refusal of participation
- Hypersensitivity to the active substance, to penicillins. History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam (e.g. cephalosporin, carbapenem or monobactam)
Key Trial Info
Start Date :
December 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2024
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04070469
Start Date
December 4 2019
End Date
December 19 2024
Last Update
January 10 2025
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000