Beta-lactamBLIPICNCT03897582
Beta-Lactams Dosing In Pneumonia in ICU in Patients Treated by Continuous Renal Replacement Therapy: the BLIPIC Study
An observational study of Beta-lactam and Continuous Renal Replacement Therapy, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial summary
Pneumonia are the most frequent infections in ICU. Little is known about beta-lactam doses necessary for this infection for patients treated with continuous veino-veinous hemodialysis. The pharmacokinetic variability expose to over and underdosage leading to toxicity or therapeutic failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Beta-lactam, Continuous Renal Replacement Therapy, Pneumonia
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2019to 31 May 2026
- 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: Adults with pneumonia in ICU treated with intraveinous beta-lactams and CVVHD
Who may be able to join
- Aged ≥ 18 years
- Receiving intraveinous beta-lactam : amoxicillin, amoxicillin-clavulanic acid, piperacillin-tazobactam, cefotaxime, ceftazidime, cefepime, meropenem, imipenem
- With AKI defined as any of the following, and treated with Multifiltrate Ci-Ca CVVHD 1000® kit with a dialysis dose of 25 ml/kg/h :
- Increase in creatininemia ≥ 0.3 mg/dl (≥ 26.5 µmol/l) within 48 hours
- Increase in creatininemia ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days
- Urine volume < 0.5 ml/kg/h for 6 hours
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- Hospitalized in ICU
- Presence of a catheter to facilitate sample collection
- With pneumonia defined as any of the following :
- Chest X-ray pneumonia : opacities, new or progressive infiltrates
- AND at least one of the following : hyperthermia > 38°C or hypothermia < 36°C with no other explanation ; leukopenia < 4 G/L ou leukocytosis > 12G/L
- AND at least one of the following : new onset purulent sputum or change in sputum character, new onset or worsening cough or dyspnea or tachypnea, rales or bronchial breathing, lower oxygen saturation/hypoxemia or increase of oxygen needs or respiratory assistance
- Treated within 24 hours by citrate hemodialysis AND beta-lactam respecting dose and administration conditions of the study :
- Amoxicillin : loading dose followed immediately by 2g by extended infusion for 4 hours every 8 hours
- Amoxicillin-clavulanic acid : 2g every 8 hours by intermittent bolus
- Piperacillin-tazobactam: loading dose followed immediately by 4g/0.5g by continuous infusion every 8 hours (< 80 kg) ou 6 hours (> 80 kg)
- Cefotaxime: loading dose followed immediately by 2g by continuous infusion every 8 hours Ceftazidime : loading dose followed immediately by 2g by continuous infusion every 8 hours
- Cefepime: loading dose followed immediately by 2g by continuous infusion every 8 hours
- Meropenem : loading dose followed immediately by 2g (> 60 kg) ou 1,33g (< 60 kg) by extended infusion for 4 hours every 8 hours
- Imipenem : loading dose followed immediately by 750 mg (< 80 kg) ou 1g (> 80 kg) by extended infusion for 4 hours every 6 hours In case of extrem weight, dose will be on investigator's discretion but administration conditions have be to respected.
- No objection has been obtained from the patient or their legally authorised representative
Who cannot join
- Aged < 18 years
- ECMO
- Cystic fibrosis
- Burn victim
- Pregnant woman
- Any rapidly-progressing disease or immediately life-threatening illness
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- Objection from the patients or their legally authorised representative
- No social security scheme
- Interruption of antibiotic before samples
- Patient in prison
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Valenciennes
Valenciennes, Nord, 59300
Elodie Matusik, + 33 6 37 94 22 60, elodie.matusik@gmail.com
Hanane Fodil, + 33 3 27 14 06 65, fodil-h@ch-valenciennes.fr
About this study
Official title: Beta-Lactams Dosing In Pneumonia in ICU in Patients Treated by Continuous Renal Replacement Therapy
Pneumonia are the most frequent infections in ICU. Little is known about beta-lactam doses necessary for this infection for patients treated with continuous veino-veinous hemodialysis. The pharmacokinetic variability expose to over and underdosage leading to toxicity or therapeutic failure. The aim of this study is to define if beta-lactams doses used in pneumonia for patients with acute kidney injury treated with our hemodialysis conditions lead to beta-lactam therapeutic plasma levels.
Read the detailed description
Pneumonia are the most frequent infections in ICU. Little is known about beta-lactam doses necessary for this infection for patients treated with continuous veino-veinous hemodialysis. The pharmacokinetic variability expose to over and underdosage leading to toxicity or therapeutic failure. The aim of this study is to define if beta-lactams doses used in pneumonia for patients with acute kidney injury treated with our hemodialysis conditions lead to beta-lactam therapeutic plasma levels.
This prospective observational multicenter study will include all patients with pneumonia treated by beta-lactam and continuous veino-veinous hemodialysis in 5 ICU. Blood sampling will be done at assumed pharmacokinetic steady state. Protocol sample concentrations of beta-lactams immediately prior to re-dosing, after 24 hours of association of intraveinous beta-lactam and continuous veino-veinous hemodialysis. Another sample will be done after 48 hours. The ICU measured bacterial MICs routinely when the pathogen will be determined. Surveyed ICUs will adopt SFM-EUCAST breakpoints for the targeted (or suspected) bacteria to determine pharmacokinetic/pharmacodynamic targets when a mesured MIC (Minimum inhibitory concentration) is not available. Local hospital antibiogram data can also be used to describe likely pathogen susceptibility. Target attainment is defined as 100% fT> 5 MIC. Due to the long delay to receive therapeutic drug monitoring results, doses could not be ajusted. Factors which could cause concentrations variations will be registered. When neurotoxicity is suspected, a sample will be realized to know beta-lactam concentration and the adverse event will be notified.
- Keywords
- amoxicillin, amoxicillin-clavulanic acid, piperacillin-tazobactam, cefotaxime, ceftazidime, cefepime, meropenem, imipenem, multifiltrate, citrate, CVVHD, extended and continuous infusion, TDM, Therapeutic Drug Monitoring
- Medical subject headings
- Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of beta-lactams concentrations above plasma therapeutic levels
We aimed to obtain concentrations over 5 MIC (Minimum inhibitory concentration) for at least 80% of patients.
Measured: Day 3 after start of antibiotic and continuous veino-veinous hemodialysis
Secondary outcomes (4)
Distribution of steady state beta-lactam concentrations and their variability
Description of beta-lactam concentration
Measured: Day 3 after start of antibiotic and continuous veino-veinous hemodialysis
Incidence of neurotoxicity
Percentage of neurotoxicity
Measured: Day 7 after start of antibiotic and continuous veino-veinous hemodialysis
Trends in beta-lactam concentrations between 2 days
Comparaison between 24 hours and 48 hours samples
Measured: At Day 1 and Day 2
Clinical response observed when beta-lactam concentrations achieved 5 MIC
Survival at Day 28 and Day 90
Measured: At Day 28 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start22 Feb 2019
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta-lactamStudies of the same condition, open and under way.
- 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Collaborators
- Centre Hospitalier de Lens, Centre Hospitalier de Bethune, University Hospital, Lille, General Hospital of Douai, Centre hospitalier de Boulogne
- Responsible party
- Sponsor
- Investigators
- Fabien Lambiotte, MD, Study chair, Centre Hospitalier de Valenciennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897582
- Sponsor's protocol ID
- 2018-05
- Acronym
- BLIPIC
- Status last verified
- Feb 2024
- First submitted
- 7 Mar 2019
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Lactams Dosing In Pneumonia in ICU in Patients Treated by Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT03897582
- Acronym / sponsor ID
- BLIPIC / 2018-05
- Keywords
- amoxicillin, amoxicillin-clavulanic acid, piperacillin-tazobactam, cefotaxime, ceftazidime, cefepime, meropenem, imipenem
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Collaborators
- Centre Hospitalier de Lens, Centre Hospitalier de Bethune, University Hospital, Lille, General Hospital of Douai, Centre hospitalier de Boulogne
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 1 Apr 2019 (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.
Pneumonia are the most frequent infections in ICU. Little is known about beta-lactam doses necessary for this infection for patients treated with continuous veino-veinous hemodialysis. The pharmacokinetic variability expose to over and underdosage leading to toxicity or therapeutic failure. The aim of this study is to define if beta-lactams doses used in pneumonia for patients with acute kidney injury treated with our hemodialysis conditions lead to beta-lactam therapeutic plasma levels.
Detailed description
Pneumonia are the most frequent infections in ICU. Little is known about beta-lactam doses necessary for this infection for patients treated with continuous veino-veinous hemodialysis. The pharmacokinetic variability expose to over and underdosage leading to toxicity or therapeutic failure. The aim of this study is to define if beta-lactams doses used in pneumonia for patients with acute kidney injury treated with our hemodialysis conditions lead to beta-lactam therapeutic plasma levels.
This prospective observational multicenter study will include all patients with pneumonia treated by beta-lactam and continuous veino-veinous hemodialysis in 5 ICU. Blood sampling will be done at assumed pharmacokinetic steady state. Protocol sample concentrations of beta-lactams immediately prior to re-dosing, after 24 hours of association of intraveinous beta-lactam and continuous veino-veinous hemodialysis. Another sample will be done after 48 hours. The ICU measured bacterial MICs routinely when the pathogen will be determined. Surveyed ICUs will adopt SFM-EUCAST breakpoints for the targeted (or suspected) bacteria to determine pharmacokinetic/pharmacodynamic targets when a mesured MIC (Minimum inhibitory concentration) is not available. Local hospital antibiogram data can also be used to describe likely pathogen susceptibility. Target attainment is defined as 100% fT> 5 MIC. Due to the long delay to receive therapeutic drug monitoring results, doses could not be ajusted. Factors which could cause concentrations variations will be registered. When neurotoxicity is suspected, a sample will be realized to know beta-lactam concentration and the adverse event will be notified.
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
- Adults with pneumonia in ICU treated with intraveinous beta-lactams and CVVHD
Key inclusion criteria (21 listed)
- Aged ≥ 18 years
- Receiving intraveinous beta-lactam : amoxicillin, amoxicillin-clavulanic acid, piperacillin-tazobactam, cefotaxime, ceftazidime, cefepime, meropenem, imipenem
- With AKI defined as any of the following, and treated with Multifiltrate Ci-Ca CVVHD 1000® kit with a dialysis dose of 25 ml/kg/h :
- Hospitalized in ICU
- Presence of a catheter to facilitate sample collection
Key exclusion criteria (10 listed)
- Aged < 18 years
- ECMO
- Cystic fibrosis
- Burn victim
- Pregnant woman
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
Percentage of beta-lactams concentrations above plasma therapeutic levels
Time frame: Day 3 after start of antibiotic and continuous veino-veinous hemodialysis
We aimed to obtain concentrations over 5 MIC (Minimum inhibitory concentration) for at least 80% of patients.
4 secondary outcomes
Distribution of steady state beta-lactam concentrations and their variability
Time frame: Day 3 after start of antibiotic and continuous veino-veinous hemodialysis
Incidence of neurotoxicity
Time frame: Day 7 after start of antibiotic and continuous veino-veinous hemodialysis
Trends in beta-lactam concentrations between 2 days
Time frame: At Day 1 and Day 2
Clinical response observed when beta-lactam concentrations achieved 5 MIC
Time frame: At Day 28 and day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- SFAR, SFPT, Recommandations de Pratiques Professionnelles, Optimisation du traitement par bêta-lactamines chez le patient de soins critiques 2018.Link provided by the sponsor.
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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.
Fabien Lambiotte, MD study chair
Centre Hospitalier de Valenciennes
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 Beta-lactam and Continuous Renal Replacement Therapy, run by Centre Hospitalier de Valenciennes 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 21 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabien Lambiotte, MD (+ 33 3 27 14 33 33 ext. 40258, lambiotte-f@ch-valenciennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of beta-lactams concentrations above plasma therapeutic levels (time frame: Day 3 after start of antibiotic and continuous veino-veinous hemodialysis). 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 2 Feb 2024.