Intensive Care UnitNCT05367011
Therapeutic Monitoring of Antibiotics in Intensive Care Patients: a Cohort Study PopTDM-ICU
An observational study of Intensive Care Unit and Antibiotic Therapy, run by Poitiers University Hospital.
Trial summary
Intensive care patients are exposed to serious infections. Mortality linked to these infections remains high and antibiotic therapy treatment optimization is one of the key points of therapeutic success . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Antibiotic Therapy, Pharmacokinetic
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with to serious infections
Who may be able to join
- Patient ≥ 18 year-old.
- Patient hospitalized in intensive care,
- Patient receiving an antibiotic for sepsis or septic shock
- Patient or family member who does not object to participating in the study
Who cannot join
- Patient at risk of death, for a cause other than infectious, within 48 hours following the introduction of antibiotic therapy.
- Patient receiving antibiotic treatment for antibiotic prophylaxis.
- Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
- Pregnant and / or lactating women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Etude de Cohorte de Suivi thérapeutique de l'antibiothérapie Chez Les Patients de réanimation
Intensive care patients are exposed to serious infections. Mortality linked to these infections remains high and antibiotic therapy treatment optimization is one of the key points of therapeutic success . Pharmacokinetic therapeutic monitoring and dosage adjustments are recommended for large families of antibiotics such as glycopeptides and aminoglycosides for a long time, but to this day still insufficiently practiced. Concerning Beta-Lactamines this practice is recommended by french society of pharmacology and therapeutic (SFPT) and french society of anesthesiology and intensive care (SFAR) since 2018.
The main goal of the POP-TDM-ICU study is to find the predictive factors of clinical therapeutic efficacy of antibiotic therapy in sepsis or septic shock in intensive care, among which the use of the dosage pharmacokinetics of antibiotic therapy (TDM = Therapeutic Drug Monitoring).
This study is a non-interventional study. Patients bacterial samples already collected in standard care and additional plasma samples will be collected as part of a biological collection with the consent of the patient or family member.
- Conditions
- Intensive Care Unit, Antibiotic Therapy, Pharmacokinetic
- Keywords
- Antibiotic, Intensive care, Therapeutic drug monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical therapeutic efficacy at the end treatment or at day 14 in the event of prolonged treatment, defined by the combination of the following 3 points.
- A disappearance of all signs and symptoms of infection, or a marked decrease in the severity of infection defined by evolution of Sequential Organ Failure Assessment (SOFA) Score. SOFA score describes the time course of multiple organ dysfunction using a limited number of routinely measured variables. The function of six organ systems is scored from 0 (no organ dysfunction) to 4 (severe organ dysfunction), and the individual organ scores are then summed to a total score between 0 and 24.
- Absence of necessary therapeutic escalation during the duration of treatment
- No antibiotic treatment for the same pathology within 48 hours of stopping treatment.
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367011
- Sponsor's protocol ID
- PopTDM-ICU
- Status last verified
- May 2022
- First submitted
- 18 Mar 2022
- Last updated
- 4 Aug 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 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de Cohorte de Suivi thérapeutique de l'antibiothérapie Chez Les Patients de réanimation
- ClinicalTrials.gov ID
- NCT05367011
- Acronym / sponsor ID
- PopTDM-ICU
- Conditions
- Intensive Care Unit, Antibiotic Therapy, Pharmacokinetic
- Keywords
- Antibiotic, Intensive care, Therapeutic drug monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 10 May 2022 (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.
Intensive care patients are exposed to serious infections. Mortality linked to these infections remains high and antibiotic therapy treatment optimization is one of the key points of therapeutic success . Pharmacokinetic therapeutic monitoring and dosage adjustments are recommended for large families of antibiotics such as glycopeptides and aminoglycosides for a long time, but to this day still insufficiently practiced. Concerning Beta-Lactamines this practice is recommended by french society of pharmacology and therapeutic (SFPT) and french society of anesthesiology and intensive care (SFAR) since 2018.
The main goal of the POP-TDM-ICU study is to find the predictive factors of clinical therapeutic efficacy of antibiotic therapy in sepsis or septic shock in intensive care, among which the use of the dosage pharmacokinetics of antibiotic therapy (TDM = Therapeutic Drug Monitoring).
This study is a non-interventional study. Patients bacterial samples already collected in standard care and additional plasma samples will be collected as part of a biological collection with the consent of the patient or family member.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients with to serious infections
Key inclusion criteria (4 listed)
- Patient ≥ 18 year-old.
- Patient hospitalized in intensive care,
- Patient receiving an antibiotic for sepsis or septic shock
- Patient or family member who does not object to participating in the study
Key exclusion criteria (4 listed)
- Patient at risk of death, for a cause other than infectious, within 48 hours following the introduction of antibiotic therapy.
- Patient receiving antibiotic treatment for antibiotic prophylaxis.
- Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
- Pregnant and / or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical therapeutic efficacy at the end treatment or at day 14 in the event of prolonged treatment, defined by the combination of the following 3 points.
Time frame: up to 14 days
* A disappearance of all signs and symptoms of infection, or a marked decrease in the severity of infection defined by evolution of Sequential Organ Failure Assessment (SOFA) Score. SOFA score describes the time course of multiple organ dysfunction using a limited number of routinely measured variables. The function of six organ systems is scored from 0 (no organ dysfunction) to 4 (severe organ dysfunction), and the individual organ scores are then summed to a total score between 0 and 24. * Absence of necessary therapeutic escalation during the duration of treatment * No antibiotic treatment for the same pathology within 48 hours of stopping treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit and Antibiotic Therapy, run by Poitiers University Hospital.
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 4 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: opening soon, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire DAHYOT-FIZELIER, Pr ((+33)5.49.44.48.40, claire.dahyot-fizelier@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical therapeutic efficacy at the end treatment or at day 14 in the event of prolonged treatment, defined by the combination of the following 3 points. (time frame: up to 14 days). 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 4 Aug 2022.