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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

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

Clinicaltrials.gov identifier NCT03927079

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted April 25, 2019

Study Description

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:Antibiotics
    Pneumonia
  • Intervention/Treatment: 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
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: April 2020
  • Estimated Study Completion Date: May 2020
Outcome Measures
  • 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)
Eligibility Criteria
  • 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

Contacts and Locations
Contacts

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

Locations

France
CHU Amiens
Amiens

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

Principal Investigator: Claire Andrejak, Pr CHU Amiens

More Information
  • 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
  • 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: Pneumonia
    broncho-alveolar lavage
    Antibiotics
  • Additional relevant MeSH terms: Pneumonia