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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897582
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborators:
Centre Hospitalier de Lens
Centre Hospitalier de Bethune
University Hospital, Lille
General Hospital of Douai
Centre hospitalier de Boulogne
Information provided by (Responsible Party):
Centre Hospitalier de Valenciennes

Brief 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.

Condition or disease
Beta-lactam Continuous Renal Replacement Therapy Pneumonia Antibiotic

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.

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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Beta-Lactams Dosing In Pneumonia in ICU in Patients Treated by Continuous Renal Replacement Therapy
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Distribution of steady state beta-lactam concentrations and their variability [ Time Frame: Day 3 after start of antibiotic and continuous veino-veinous hemodialysis ]
    Description of beta-lactam concentration

  2. Incidence of neurotoxicity [ Time Frame: Day 7 after start of antibiotic and continuous veino-veinous hemodialysis ]
    Percentage of neurotoxicity

  3. Trends in beta-lactam concentrations between 2 days [ Time Frame: At Day 1 and Day 2 ]
    Comparaison between 24 hours and 48 hours samples

  4. Clinical response observed when beta-lactam concentrations achieved 5 MIC [ Time Frame: At Day 28 and day 90 ]
    Survival at Day 28 and Day 90



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with pneumonia in ICU treated with intraveinous beta-lactams and CVVHD
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897582


Contacts
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Contact: Fabien Lambiotte, MD + 33 3 27 14 33 33 ext 40258 lambiotte-f@ch-valenciennes.fr
Contact: Justine Lemtiri, Pharm D + 33 3 27 14 33 33 ext 49732 lemtiri-j@ch-valenciennes.fr

Locations
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France
Centre Hospitalier de Valenciennes Recruiting
Valenciennes, Nord, France, 59300
Contact: Elodie Matusik    + 33 6 37 94 22 60    elodie.matusik@gmail.com   
Contact: Hanane Fodil    + 33 3 27 14 06 65    fodil-h@ch-valenciennes.fr   
Sub-Investigator: Guillaume Brunin, MD         
Sub-Investigator: Nicolas Van Grunderbeeck, MD         
Sub-Investigator: Christophe Vinsonneau, MD         
Sub-Investigator: Chloé Rousselin, MD         
Sponsors and Collaborators
Centre Hospitalier de Valenciennes
Centre Hospitalier de Lens
Centre Hospitalier de Bethune
University Hospital, Lille
General Hospital of Douai
Centre hospitalier de Boulogne
Investigators
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Study Chair: Fabien Lambiotte, MD Centre Hospitalier de Valenciennes

Additional Information:
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Responsible Party: Centre Hospitalier de Valenciennes
ClinicalTrials.gov Identifier: NCT03897582    
Other Study ID Numbers: 2018-05
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier de Valenciennes:
amoxicillin
amoxicillin-clavulanic acid
piperacillin-tazobactam
cefotaxime
ceftazidime
cefepime
meropenem
imipenem
multifiltrate
citrate
CVVHD
extended and continuous infusion
TDM
Therapeutic Drug Monitoring
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Lactams
beta-Lactams
Anti-Bacterial Agents
Anti-Infective Agents