Amikacin TreatmentAMIDIAL-ICUNCT04322019
Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study
An observational study of Amikacin Treatment, run by CHU de Reims at 1 site in France.
Trial summary
Amikacin is the aminoglycoside of choice for treatment of severe infections in intensive care. An achievement of its objectives in pharmacokinetics and pharmacodynamics is difficult in intensive care patients because of modification of their volume of distribution and renal clearance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amikacin Treatment
- What is being tested?
- Data record
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2020to 16 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care patients on renal replacement therapy with Amikacin treatment
Who may be able to join
- patients in intensive care
- patients on extrarenal replacement
- patients with Amikacin treatment
- patients accepting to participate in the study
Who cannot join
- patients less than 18 years old
- pregnant women
- patients with Amikacin treatment in the previous 7 days
Trial locations and contacts
1 site in 1 country.
About this study
Amikacin is the aminoglycoside of choice for treatment of severe infections in intensive care. An achievement of its objectives in pharmacokinetics and pharmacodynamics is difficult in intensive care patients because of modification of their volume of distribution and renal clearance. Acute renal failure requiring renal replacement therapy is frequent in intensive care. Extrarenal purification modalities (continuous versus intermittent, type of dialysis membrane), which can influence amikacin clearance, are multiple and teams dependent. Guidelines of good practice for Amikacin in intensive care patients do not exist.
Read the detailed description
The aim of this study is to describe strategies of prescription and monitoring of Amikacin in intensive care patients on renal replacement therapy.
- Conditions
- Amikacin Treatment
- Being tested
- Data record
- Keywords
- Amikacin, intensive care, renal replacement therapy, prescription strategy,, monitoring strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data recordOther
Data record
| Study group | Role | What they receive |
|---|---|---|
| "Amikacin treatment" group | Intensive care patients on renal replacement therapy with Amikacin treatment Receives: Other: Data record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of maximum concentration observed
Monitoring of Amikacin treatment using measurement of maximum concentration observed performed or not
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start25 May 2020
- Primary completion16 Feb 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amikacin TreatmentStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322019
- Sponsor's protocol ID
- PO20032
- Acronym
- AMIDIAL-ICU
- Status last verified
- Jun 2022
- First submitted
- 24 Mar 2020
- Last updated
- 16 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT04322019
- Acronym / sponsor ID
- AMIDIAL-ICU / PO20032
- Conditions
- Amikacin Treatment
- Keywords
- Amikacin, intensive care, renal replacement therapy, prescription strategy,, monitoring strategy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Amikacin is the aminoglycoside of choice for treatment of severe infections in intensive care. An achievement of its objectives in pharmacokinetics and pharmacodynamics is difficult in intensive care patients because of modification of their volume of distribution and renal clearance. Acute renal failure requiring renal replacement therapy is frequent in intensive care. Extrarenal purification modalities (continuous versus intermittent, type of dialysis membrane), which can influence amikacin clearance, are multiple and teams dependent. Guidelines of good practice for Amikacin in intensive care patients do not exist.
Detailed description
The aim of this study is to describe strategies of prescription and monitoring of Amikacin in intensive care patients on renal replacement therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "Amikacin treatment" group | – | Other: Data recordIntensive care patients on renal replacement therapy with Amikacin treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients on renal replacement therapy with Amikacin treatment
Key inclusion criteria (4 listed)
- patients in intensive care
- patients on extrarenal replacement
- patients with Amikacin treatment
- patients accepting to participate in the study
Key exclusion criteria (3 listed)
- patients less than 18 years old
- pregnant women
- patients with Amikacin treatment in the previous 7 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data recordData record | Other | "Amikacin treatment" group |
Primary outcome
Measurement of maximum concentration observed
Time frame: Day 0
Monitoring of Amikacin treatment using measurement of maximum concentration observed performed or not
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amikacin Treatment, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of maximum concentration observed (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.