Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can High-Dose amoxicillin be made safer?

NCT ID NCT04070469

Knowledge-focused Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study looks at patients receiving high-dose intravenous amoxicillin for serious bacterial infections. Researchers will measure drug levels in the blood during the first week to see how much they vary between patients and within the same patient. They will also check for side effects like kidney problems (crystalluria) and aim to identify factors linked to overdose. The goal is to gather information that could lead to safer, more personalized dosing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amoxicillin
What this could lead to
If successful, this could help define safer dosing targets for high-dose amoxicillin, reducing kidney and neurological side effects in serious infections.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may not lead to immediate practice changes, and individual responses vary widely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

142 people

The number who actually took part.

Started

Dec 2019

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Infection, bacterial are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

bacterial infectious disease Crystalluria Drug-Related Side Effects and Adverse Reactions

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infection, bacterial

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.