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RecruitingNCT03897582BLIPICUpdated Feb 2, 2024

Beta-Lactams Dosing In Pneumonia in ICU in Patients Treated by Continuous Renal Replacement Therapy: the BLIPIC Study

An observational study in Beta-lactam, Continuous Renal Replacement Therapy and Pneumonia, sponsored by Centre Hospitalier de Valenciennes. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-02.

Sponsored by Centre Hospitalier de Valenciennes · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Feb 2019; still recruiting 7 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Beta-lactam
  • Continuous Renal Replacement Therapy
  • Pneumonia
  • Antibiotic

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Keywords

  • amoxicillin
  • amoxicillin-clavulanic acid
  • piperacillin-tazobactam
  • cefotaxime
  • ceftazidime
  • cefepime
  • meropenem
  • imipenem
  • multifiltrate
  • citrate
  • CVVHD
  • extended and continuous infusion
  • TDM
  • Therapeutic Drug Monitoring
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 65 is below the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Centre Hospitalier de Valenciennes is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adults with pneumonia in ICU treated with intraveinous beta-lactams and CVVHD

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • Aged \< 18 years
  • ECMO
  • Cystic fibrosis
  • Burn victim
  • Pregnant woman
  • Any rapidly-progressing disease or immediately life-threatening illness
  • Objection from the patients or their legally authorised representative
  • No social security scheme
  • Interruption of antibiotic before samples
  • Patient in prison
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 3 after start of antibiotic and continuous veino-veinous hemodialysis

Secondary outcomes

  1. Distribution of steady state beta-lactam concentrations and their variability

    Description of beta-lactam concentration

    Time frame: Day 3 after start of antibiotic and continuous veino-veinous hemodialysis

  2. Incidence of neurotoxicity

    Percentage of neurotoxicity

    Time frame: Day 7 after start of antibiotic and continuous veino-veinous hemodialysis

  3. Trends in beta-lactam concentrations between 2 days

    Comparaison between 24 hours and 48 hours samples

    Time frame: At Day 1 and Day 2

  4. Clinical response observed when beta-lactam concentrations achieved 5 MIC

    Survival at Day 28 and Day 90

    Time frame: At Day 28 and day 90

07

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier de Valenciennes
    Valenciennes, Nord 59300, France
    • Elodie Matusik · Contact · elodie.matusik@gmail.com · + 33 6 37 94 22 60
    • Hanane Fodil · Contact · fodil-h@ch-valenciennes.fr · + 33 3 27 14 06 65
    • Guillaume Brunin, MD · Sub investigator
    • Nicolas Van Grunderbeeck, MD · Sub investigator
    • Christophe Vinsonneau, MD · Sub investigator
    • Geneviève Barjon, MD · Sub investigator
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03897582
Lead sponsor
Centre Hospitalier de Valenciennes
Collaborators
Centre Hospitalier de Lens, Centre Hospitalier de Bethune, University Hospital, Lille, General Hospital of Douai, Centre hospitalier de Boulogne
Responsible party
Sponsor
First posted
Apr 1, 2019
Start date
Feb 22, 2019
Primary completion
May 31, 2026 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Feb 2, 2024

Study contacts

Fabien Lambiotte, MD
Contact
lambiotte-f@ch-valenciennes.fr
+ 33 3 27 14 33 33 ext. 40258
Justine Lemtiri, Pharm D
Contact
lemtiri-j@ch-valenciennes.fr
+ 33 3 27 14 33 33 ext. 49732
Fabien Lambiotte, MD
study chair · Centre Hospitalier de Valenciennes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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