Plasma Concentrations of Amoxicillin Administered in High-doses During the First Week of Treatment (MAX-AMOX)

NCT04070469 | Completed Phase 4

• 2 other identifiers: RBHP 2019 VIDAL (MAX-AMOX)2019-002824-34
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Infection, Bacterial

Keywords

amoxycillin; drug kinetics; drug toxicity; crystalluria

Outcome Measures

Primary Outcomes (3)

• Residual plasma concentrations of administered in high doses amoxicillin

  research of Residual plasma concentrations of amoxicillin

  Day 7

• Residual plasma concentrations of administered in high doses amoxicillin

  research of Residual plasma concentrations of amoxicillin

  Day 4

• Residual plasma concentrations of administered in high doses amoxicillin

  research of Residual plasma concentrations of amoxicillin

  Day 1

Secondary Outcomes (30)

• search for cystalluria, description of crystals, and infrared spectropscopy to determine crystals composition

  Day 7

• search for cystalluria, description of crystals, and infrared spectropscopy to determine crystals composition

  Day 4

• search for cystalluria, description of crystals, and infrared spectropscopy to determine crystals composition

  Day 1

• proportion of residual plasma concentrations above 10 minimal inhibitory concentration (MIC)

  day 7

• proportion of residual plasma concentrations above 10 minimal inhibitory concentration (MIC)

  day 4

Study Arms (1)

Patient reveiving amoxycillin

EXPERIMENTAL

all patient included in this study

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

dosage of plasma concentration of amoxicillin

Also known as: amoxicillin treatment

Patient reveiving amoxycillin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Bacterial Infections; Drug-Related Side Effects and Adverse Reactions; Crystalluria

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Chemically-Induced Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Magali VIDAL

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 28, 2019
• Study Start: December 4, 2019
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

FR (1)