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Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage (ABBA)

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ClinicalTrials.gov Identifier: NCT03927079
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
Respiratory infections are common and sometimes very severe. An insufficient dosage of the antibiotic could lead to a treatment failure A correct plasmatic antibiotic concentration is not a guarantee of a clinical success as it could not be a reflect of pulmonary concentration. The aim of this study is to determinate the predictive factors of pulmonary penetration of antibiotics in patients with a beta lactamines failure and who undergoes a flexible bronchoscopy.

Condition or disease Intervention/treatment Phase
Antibiotics Pneumonia Biological: measure of intra-alveolar antibiotic concentration in µg/ml Procedure: broncho-alveolar lavage (BAL) Biological: blood test to measure plasmatic antibiotic concentration in µg/ml Not Applicable

Detailed Description:
To check if pulmonary concentrations of antibiotic are enough we will measure antibiotic concentration in the broncho-alveolar lavage (BAL). This technique which is clinically relevant and reliable could determinate the pulmonary diffusion level for antibiotics by calculating the ratio between plasmatic and intra-alveolar antibiotic concentration. This ratio will be correlated with potential limitation factors of pulmonary diffusion as respiratory diseases (COPD, cystic fibrosis, fibrosis…), sepsis, hypoalbuminemia. We have chosen to study the beta lactamin antibiotics because they are the most frequently used in pneumonia. Moreover, the beta lactamins pulmonary diffusion is likely to be the lowest. Finally, for patients with a known pathogen, we will divide this pulmonary concentration with minimal inhibitory concentration (MIC). Indeed, in severe pneumonia, to be sure of bactericidal activity, a pulmonary concentration of beta lactamines should be always higher than 4 to 5 times MIC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Factors of Good Pulmonary Penetration of Antibiotics : AntiBiotics Dosage in Broncho-Alveolar Lavage
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics


Intervention Details:
  • Biological: measure of intra-alveolar antibiotic concentration in µg/ml
    included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic concentration
  • Procedure: broncho-alveolar lavage (BAL)
    included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic concentration
  • Biological: blood test to measure plasmatic antibiotic concentration in µg/ml
    included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic


Primary Outcome Measures :
  1. pulmonary diffusion level for beta lactamins [ Time Frame: on the day of the bronco-alveolar lavage ]
    pulmonary diffusion level for beta lactamins is determined by ratio between bronchoalveolar concentration and plasmatic concentration of tested antibiotics


Secondary Outcome Measures :
  1. measure of apyrexia duration in days [ Time Frame: from day of inclusion to 15 days after inclusion ]
    measure of apyrexia duration in days

  2. duration in days for regression of the biological inflammatory syndrome [ Time Frame: from day of inclusion to 15 days after inclusion ]
    duration in days for regression of the biological inflammatory syndrome (CRP concentration in mg/l divided by 2)

  3. measure of length of hospitalisation [ Time Frame: from day of inclusion to 15 days after inclusion ]
    measure of length of hospitalisation in days

  4. Number of deaths at 28-day [ Time Frame: 28 days after inclusion ]
    28-day mortality will be measured

  5. virus presence in BAL [ Time Frame: day of bronchoalveolar lavage (BAL) ]
    virus presence will be detected in bronchoalveolar lavage (BAL)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who undergo a flexible bronchoscopic lavage and with a beta lactamines treatment as cephalosporin of 3rd generation (CEFTRIAXONE / CEFOTAXIME, CEFTAZIDIME), of 4th generation (CEFEPIM), or AMOXICILLIN-CLAVULANIC ACID, or PIPERACILLIN-TAZOBACTAM
  • patient major
  • informed and signed consent form

Exclusion Criteria:

  • patient under chronic dialysis
  • patient placed under judicial protection

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): NCT03927079


Contacts
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Contact: Claire Andrejak, Pr (33)3 22 08 78 93 andrejak.claire@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: claire Andrejak, Pr    (33)3 22 08 78 93    andrejak.claire@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Claire Andrejak, Pr CHU Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03927079     History of Changes
Other Study ID Numbers: PI2018_843_0032
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Universitaire, Amiens:
Antibiotics
Pneumonia
broncho-alveolar lavage

Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents