Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT04070469
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04070469
Study Brief:
Protocol Section:
NCT04070469