Critical IllnessDOSATBNCT04530045
Target Attainment of TDM-guided Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients
An observational study of Critical Illness and Antibiotic Toxicity, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
Although alternative dosing strategies can improve antimicrobial exposure in critically ill patients, the high PK variability in this population means that some may still receive sub-optimal antibiotic exposure leading to unfavourable clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Antibiotic Toxicity, Sepsis
- What is being tested?
- dosage of concentration of piperacillin and cefepim
- Type of treatment
- Injection or infusion
- How many people
- 99 participants
- Where
- 2 sitesFrance
- Study dates
- 2 May 2018to 2 Nov 2019
- 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: Critically ill patients admitted to the surgical intensive care unit whatever the reason of admission and who received piperacilin or cefepim with a TDM for sepsis or septic shock during their stay.
Who may be able to join
- Minimun age limits 18 years
- Critically ill patient receiving piperacillin or cefepim administered continuously
Who cannot join
- Beta lactam allergy
- Pregnancy
- Age less than 18 years
Trial locations and contacts
2 sites in 1 country.
France2 sites
Emmanuel NOVY
Vandœuvre-lès-Nancy, Lorraine, 54500
Central Hospital
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Target Attainment of TDM-guided Continuous Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients: a Prospective Observational Study
Although alternative dosing strategies can improve antimicrobial exposure in critically ill patients, the high PK variability in this population means that some may still receive sub-optimal antibiotic exposure leading to unfavourable clinical outcomes.
Therapeutic drug management (TDM) guided dosing is the only safe and effective way to ensure that all critically ill patients achieve therapeutic antimicrobial exposures and to minimise the likelihood of toxicity.
For experts, TDM should be a standard of care, in particular for β-lactams. Nevertheless, because of the assay method for β-lactams and the need for bioanalytical experts, delays in obtaining results frequently occurred. These barriers, combined with difficulties in the interpretation of TDM results, need to be addressed in order to increase its routine utilization. Consequently, study aiming at identify which subgroup of patients or infection are more likely to benefit from TDM are urgently warranted This prospective observational study aimed at evaluating target attainment of piperacillin/tazobactam (PIP/TAZ) and cefepim (CEF) with the use of a Therapeutic Drug Monitoring (TDM) in critically patients during the routine care
- Conditions
- Critical Illness, Antibiotic Toxicity, Sepsis, Septic Shock
- Being tested
- dosage of concentration of piperacillin and cefepim
- Keywords
- therapeutic drug monitoring
- Medical subject headings
- Critical Illness, Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dosage of concentration of piperacillin and cefepimOther
Dosage of total plasma concentration of piperacillin and cefepim at different timepoints
| Study group | Role | What they receive |
|---|---|---|
| critically ill patients | Critically ill patients receiving continuous infusion of piperacillin/tazbactam or cefepim and dosage of plasma concentration of the B lactam administered Receives: Other: dosage of concentration of piperacillin and cefepim |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the percentage of patients who met the PK/PD targets at 24 hours
PK/PD target was defined as follows:
Concentration of piperacillin or cefepim between a lower and a upper limit:
- The lower limit was defined as estimated free concentration above 4 times the epidemiological cut-off value of suspected bacteria
- The upper limit was based on known limit of neurotoxicity, namely 35 and 160 mg/L for cefepim and piperacillin, respectively
Consequently :
- for piperacillin : the PK/PD target is considered to be reach if the free concentration of PIPERACILLIN/TAZOBACTAM is between 32 and 160 mg/l
- for cefepim : the PK/PD target is considered to be reach if the free concentration of CEFEPIM is between 4 and 35 mg/l
Measured: Day 1
Secondary outcomes (6)
to determine the percentage of patients who met the PK/PD targets "exposure" at 24 hours
PK/PD target "exposure" take into account only the the lower limit was defined as estimated free concentration above 4 times the epidemiological cut-off value of suspected bacteria
Consequently :
- for piperacillin : the PK/PD target is considered to be reach if the free concentration of PIPERACILLIN/TAZOBACTAM is above 32 mg/l
- for cefepim : the PK/PD target is considered to be reach if the free concentration of CEFEPIM is above 4 mg/l
Measured: Day 1
factors associated with target attainment at day 1
effect of age on antibiotic concentration
Measured: Statistical analysis after 2 years of inclusion
factors associated with target attainment at day 1
effect of renal clearance on antibiotic concentration
Measured: Statistical analysis after 2 years of inclusion
factors associated with target attainment at day 1
effect of presence of septic shock on antibiotic concentration
Measured: Statistical analysis after 2 years of inclusion
factors associated with dose changing
effect of presence of septic shock on number of dose changing after analyse of antibiotic concentration
Measured: Statistical analysis after 2 years of inclusion
factors associated with dose changing
effect of renal clearance on number of dose changing after analyse of antibiotic concentration
Measured: Statistical analysis after 2 years of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start2 May 2018
- Primary completion1 Nov 2019
- Study completion2 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel NOVY, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530045
- Sponsor's protocol ID
- PSS2018/DOSATB-NOVY/YB
- Acronym
- DOSATB
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Attainment of TDM-guided Continuous Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04530045
- Acronym / sponsor ID
- DOSATB / PSS2018/DOSATB-NOVY/YB
- Conditions
- Critical Illness, Antibiotic Toxicity, Sepsis, Septic Shock
- Keywords
- therapeutic drug monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 2 Nov 2019 (actual)
- First posted
- 28 Aug 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.
Although alternative dosing strategies can improve antimicrobial exposure in critically ill patients, the high PK variability in this population means that some may still receive sub-optimal antibiotic exposure leading to unfavourable clinical outcomes.
Therapeutic drug management (TDM) guided dosing is the only safe and effective way to ensure that all critically ill patients achieve therapeutic antimicrobial exposures and to minimise the likelihood of toxicity.
For experts, TDM should be a standard of care, in particular for β-lactams. Nevertheless, because of the assay method for β-lactams and the need for bioanalytical experts, delays in obtaining results frequently occurred. These barriers, combined with difficulties in the interpretation of TDM results, need to be addressed in order to increase its routine utilization. Consequently, study aiming at identify which subgroup of patients or infection are more likely to benefit from TDM are urgently warranted This prospective observational study aimed at evaluating target attainment of piperacillin/tazobactam (PIP/TAZ) and cefepim (CEF) with the use of a Therapeutic Drug Monitoring (TDM) in critically patients during the routine care
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| critically ill patients | – | Other: dosage of concentration of piperacillin and cefepimCritically ill patients receiving continuous infusion of piperacillin/tazbactam or cefepim and dosage of plasma concentration of the B lactam administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to the surgical intensive care unit whatever the reason of admission and who received piperacilin or cefepim with a TDM for sepsis or septic shock during their stay.
Key inclusion criteria (2 listed)
- Minimun age limits 18 years
- Critically ill patient receiving piperacillin or cefepim administered continuously
Key exclusion criteria (3 listed)
- Beta lactam allergy
- Pregnancy
- Age less than 18 years
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 |
|---|---|---|
| dosage of concentration of piperacillin and cefepimDosage of total plasma concentration of piperacillin and cefepim at different timepoints | Other | critically ill patients |
Primary outcome
to determine the percentage of patients who met the PK/PD targets at 24 hours
Time frame: Day 1
PK/PD target was defined as follows: Concentration of piperacillin or cefepim between a lower and a upper limit: * The lower limit was defined as estimated free concentration above 4 times the epidemiological cut-off value of suspected bacteria * The upper limit was based on known limit of neurotoxicity, namely 35 and 160 mg/L for cefepim and piperacillin, respectively Consequently : * for piperacillin : the PK/PD target is considered to be reach if the free concentration of PIPERACILLIN/TAZOBACTAM is between 32 and 160 mg/l * for cefepim : the PK/PD target is considered to be reach if the free concentration of CEFEPIM is between 4 and 35 mg/l
6 secondary outcomes
to determine the percentage of patients who met the PK/PD targets "exposure" at 24 hours
Time frame: Day 1
factors associated with target attainment at day 1
Time frame: Statistical analysis after 2 years of inclusion
factors associated with target attainment at day 1
Time frame: Statistical analysis after 2 years of inclusion
factors associated with target attainment at day 1
Time frame: Statistical analysis after 2 years of inclusion
factors associated with dose changing
Time frame: Statistical analysis after 2 years of inclusion
factors associated with dose changing
Time frame: Statistical analysis after 2 years of inclusion
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 28 Aug 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Emmanuel NOVY principal investigator
Central Hospital, Nancy, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Antibiotic Toxicity, run by Central Hospital, Nancy, France at 2 sites 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 2 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 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
to determine the percentage of patients who met the PK/PD targets at 24 hours (time frame: Day 1). 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 28 Aug 2020.